{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T14:31:59Z","timestamp":1782916319183,"version":"3.54.5"},"reference-count":122,"publisher":"National Institute for Health and Care Research","issue":"39","license":[{"start":{"date-parts":[[2019,8,1]],"date-time":"2019-08-01T00:00:00Z","timestamp":1564617600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["12\/200\/04"],"award-info":[{"award-number":["12\/200\/04"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000265","name":"Medical Research Council","doi-asserted-by":"publisher","award":["MR\/K025643\/1"],"award-info":[{"award-number":["MR\/K025643\/1"]}],"id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"\n Background<\/jats:title>\n Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n Phase A \u2013 semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B \u2013 pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved.<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n Usual NHS care.<\/jats:p>\n <\/jats:sec>\n \n Participants<\/jats:title>\n Patients undergoing elective\/non-elective abdominal surgery, including caesarean section.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Phase A \u2013 none. Phase B \u2013 simple dressing, glue-as-a-dressing (tissue adhesive) or \u2018no dressing\u2019.<\/jats:p>\n <\/jats:sec>\n \n Main outcome measures<\/jats:title>\n Phase A \u2013 pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B \u2013 participants screened, proportions consented\/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers.<\/jats:p>\n <\/jats:sec>\n \n Data sources<\/jats:title>\n Phase A \u2013 interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B \u2013 participants and HCPs in five hospitals.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Phase A \u2013 we interviewed 102 participants. HCPs interpreted \u2018dressing\u2019 variably and reported using available products. HCPs suggested practical\/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a \u2018no dressing\u2019 group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of \u00a320,000 per quality-adjusted life-year. Phase B \u2013 from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n<\/jats:italic>\u2009=\u2009133; glue, n<\/jats:italic>\u2009=\u2009129; no dressing, n<\/jats:italic>\u2009=\u2009132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients\u2019 understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test\u2013retest and Cronbach\u2019s alpha of >\u20090.7) and diagnostic accuracy (c<\/jats:italic>-statistic\u2009=\u20090.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments.<\/jats:p>\n <\/jats:sec>\n \n Limitations<\/jats:title>\n Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4\u20138 weeks.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n Phase A \u2013 Current Controlled Trials ISRCTN06792113; Phase B \u2013 Current Controlled Trials ISRCTN49328913.<\/jats:p>\n <\/jats:sec>\n \n Funding<\/jats:title>\n This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment<\/jats:italic>; Vol. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR\/K025643\/1).<\/jats:p>\n <\/jats:sec>","DOI":"10.3310\/hta23390","type":"journal-article","created":{"date-parts":[[2019,8,8]],"date-time":"2019-08-08T09:21:06Z","timestamp":1565256066000},"page":"1-166","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":13,"title":["Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT"],"prefix":"10.3310","volume":"23","clinical-trial-number":[{"clinical-trial-number":"isrctn06792113","registry":"10.18810\/isrctn","type":"results"},{"clinical-trial-number":"isrctn49328913","registry":"10.18810\/isrctn","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5101-9487","authenticated-orcid":true,"given":"Barnaby C","family":"Reeves","sequence":"first","affiliation":[{"name":"Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6166-6055","authenticated-orcid":true,"given":"Leila","family":"Rooshenas","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6606-5427","authenticated-orcid":true,"given":"Rhiannon C","family":"Macefield","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9808-8842","authenticated-orcid":true,"given":"Mark","family":"Woodward","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2198-3205","authenticated-orcid":true,"given":"Nicky J","family":"Welton","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6277-8833","authenticated-orcid":true,"given":"Benjamin R","family":"Waterhouse","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0558-8280","authenticated-orcid":true,"given":"Andrew D","family":"Torrance","sequence":"additional","affiliation":[{"name":"Department of Surgery, Sandwell and West Birmingham NHS Trust, West Bromwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1001-7127","authenticated-orcid":true,"given":"Sean","family":"Strong","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"},{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1078-9856","authenticated-orcid":true,"given":"Dimitrios","family":"Siassakos","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"},{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6061-7342","authenticated-orcid":true,"given":"William","family":"Seligman","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9624-2615","authenticated-orcid":true,"given":"Chris A","family":"Rogers","sequence":"additional","affiliation":[{"name":"Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1165-2587","authenticated-orcid":true,"given":"Lloyd","family":"Rickard","sequence":"additional","affiliation":[{"name":"University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2199-1777","authenticated-orcid":true,"given":"Anne","family":"Pullyblank","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4539-8123","authenticated-orcid":true,"given":"Caroline","family":"Pope","sequence":"additional","affiliation":[{"name":"Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7320-6673","authenticated-orcid":true,"given":"Thomas D","family":"Pinkney","sequence":"additional","affiliation":[{"name":"Academic Department of Surgery, Queen Elizabeth Hospital, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0535-1470","authenticated-orcid":true,"given":"Samir","family":"Pathak","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2537-7643","authenticated-orcid":true,"given":"Anwar","family":"Owais","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9898-5930","authenticated-orcid":true,"given":"Jamie","family":"O\u2019Callaghan","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3133-8920","authenticated-orcid":true,"given":"Stephen","family":"O\u2019Brien","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2171-2862","authenticated-orcid":true,"given":"Dmitri","family":"Nepogodiev","sequence":"additional","affiliation":[{"name":"University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"},{"name":"Academic Department of Surgery, Queen Elizabeth Hospital, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0181-1089","authenticated-orcid":true,"given":"Khaldoun","family":"Nadi","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0838-2694","authenticated-orcid":true,"given":"Charlotte E","family":"Murkin","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"},{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5995-6275","authenticated-orcid":true,"given":"Tonia","family":"Munder","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4168-8943","authenticated-orcid":true,"given":"Tom","family":"Milne","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9880-2073","authenticated-orcid":true,"given":"David","family":"Messenger","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0878-1513","authenticated-orcid":true,"given":"Christel M","family":"McMullan","sequence":"additional","affiliation":[{"name":"Institute of Applied Health Research, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6651-6286","authenticated-orcid":true,"given":"Jonathan M","family":"Mathers","sequence":"additional","affiliation":[{"name":"Institute of Applied Health Research, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5067-8272","authenticated-orcid":true,"given":"Matthew","family":"Mason","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1017-7814","authenticated-orcid":true,"given":"Morwena","family":"Marshall","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4347-5607","authenticated-orcid":true,"given":"Richard","family":"Lovegrove","sequence":"additional","affiliation":[{"name":"Worcestershire Acute Hospitals NHS Trust, Worcester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6398-6386","authenticated-orcid":true,"given":"Robert J","family":"Longman","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1012-4026","authenticated-orcid":true,"given":"Jessica","family":"Lloyd","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8126-6737","authenticated-orcid":true,"given":"Jeffrey","family":"Lim","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0150-4513","authenticated-orcid":true,"given":"Kathryn","family":"Lee","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6946-0345","authenticated-orcid":true,"given":"Vijay","family":"Korwar","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7167-1325","authenticated-orcid":true,"given":"Daniel","family":"Hughes","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9863-5658","authenticated-orcid":true,"given":"George","family":"Hill","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2405-667X","authenticated-orcid":true,"given":"Rosie","family":"Harris","sequence":"additional","affiliation":[{"name":"Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7315-3441","authenticated-orcid":true,"given":"Mohammed","family":"Hamdan","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"},{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6130-4118","authenticated-orcid":true,"given":"Hannah Gould","family":"Brown","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3353-2882","authenticated-orcid":true,"given":"Rachael","family":"Gooberman-Hill","sequence":"additional","affiliation":[{"name":"Musculoskeletal Research Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7688-5018","authenticated-orcid":true,"given":"James","family":"Glasbey","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2121-7028","authenticated-orcid":true,"given":"Caroline","family":"Fryer","sequence":"additional","affiliation":[{"name":"University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8179-5172","authenticated-orcid":true,"given":"Lucy","family":"Ellis","sequence":"additional","affiliation":[{"name":"Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8143-9549","authenticated-orcid":true,"given":"Daisy","family":"Elliott","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6546-3685","authenticated-orcid":true,"given":"Jo C","family":"Dumville","sequence":"additional","affiliation":[{"name":"Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1825-4864","authenticated-orcid":true,"given":"Tim","family":"Draycott","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6488-5472","authenticated-orcid":true,"given":"Jenny L","family":"Donovan","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"},{"name":"National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West at University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5165-3579","authenticated-orcid":true,"given":"David","family":"Cotton","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3537-5166","authenticated-orcid":true,"given":"Joanna","family":"Coast","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7645-1199","authenticated-orcid":true,"given":"Madeleine","family":"Clout","sequence":"additional","affiliation":[{"name":"Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1856-837X","authenticated-orcid":true,"given":"Melanie J","family":"Calvert","sequence":"additional","affiliation":[{"name":"Institute of Applied Health Research, University of Birmingham, Birmingham, UK"},{"name":"Centre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2183-8166","authenticated-orcid":true,"given":"Benjamin E","family":"Byrne","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5781-7116","authenticated-orcid":true,"given":"Oliver D","family":"Brown","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6111-2175","authenticated-orcid":true,"given":"Natalie S","family":"Blencowe","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"},{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3795-6762","authenticated-orcid":true,"given":"Katarzyna D","family":"Bera","sequence":"additional","affiliation":[{"name":"Clinical Academic Graduate School, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7077-5800","authenticated-orcid":true,"given":"Joanne","family":"Bennett","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8328-0906","authenticated-orcid":true,"given":"Richard","family":"Bamford","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1906-5069","authenticated-orcid":true,"given":"Danya","family":"Bakhbakhi","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3584-6404","authenticated-orcid":true,"given":"Muhammad","family":"Atif","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9163-0512","authenticated-orcid":true,"given":"Kate","family":"Ashton","sequence":"additional","affiliation":[{"name":"Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7609-2453","authenticated-orcid":true,"given":"Elizabeth","family":"Armstrong","sequence":"additional","affiliation":[{"name":"North Bristol NHS Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7998-7431","authenticated-orcid":true,"given":"Lazaros","family":"Andronis","sequence":"additional","affiliation":[{"name":"Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4360-8991","authenticated-orcid":true,"given":"Piriyankan","family":"Ananthavarathan","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3354-3330","authenticated-orcid":true,"given":"Jane M","family":"Blazeby","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"},{"name":"University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2019,8]]},"reference":[{"key":"key20190807105109648_ref1-bib1","unstructured":"Royal College of Surgeons. From Theory to Theatre: Overcoming Barriers to Innovation in Surgery. London: Royal College of Surgeons; 2011."},{"key":"key20190807105109648_ref1-bib2","doi-asserted-by":"publisher","first-page":"f4305","DOI":"10.1136\/bmj.f4305","article-title":"Impact of wound edge protection devices on surgical site infection after laparotomy: multi-centre randomised controlled trial (ROSSINI trial)","volume":"347","author":"Pinkney","year":"2013","journal-title":"BMJ"},{"key":"key20190807105109648_ref1-bib3","doi-asserted-by":"publisher","first-page":"93","DOI":"10.1016\/j.jhin.2004.10.019","article-title":"Adverse impact of surgical site infections in English hospitals","volume":"60","author":"Coello","year":"2005","journal-title":"J Hosp Infect"},{"key":"key20190807105109648_ref1-bib4","doi-asserted-by":"publisher","first-page":"725","DOI":"10.1086\/501572","article-title":"The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs","volume":"20","author":"Kirkland","year":"1999","journal-title":"Infect Control Hosp Epidemiol"},{"key":"key20190807105109648_ref1-bib5","doi-asserted-by":"publisher","first-page":"198","DOI":"10.1053\/jhin.2000.0881","article-title":"The rate and cost of hospital-acquired infections occurring in patients admitted to selected specialties of a district general hospital in England and the national burden imposed","volume":"47","author":"Plowman","year":"2001","journal-title":"J Hosp Infect"},{"key":"key20190807105109648_ref1-bib6","doi-asserted-by":"publisher","first-page":"243","DOI":"10.1016\/j.jhin.2009.03.021","article-title":"Post-discharge surveillance to identify colorectal surgical site infection rates and related costs","volume":"72","author":"Tanner","year":"2009","journal-title":"J Hosp Infect"},{"key":"key20190807105109648_ref1-bib7","doi-asserted-by":"publisher","first-page":"623","DOI":"10.1086\/589331","article-title":"Economic burden of surgical site infections at a European university hospital","volume":"29","author":"Weber","year":"2008","journal-title":"Infect Control Hosp Epidemiol"},{"key":"key20190807105109648_ref1-bib8","first-page":"1","article-title":"Postoperative wound infections: the influence of ultraviolet irradiation of the operating room and of various other factors","volume":"160","author":"Berard","year":"1964","journal-title":"Ann Surg"},{"key":"key20190807105109648_ref1-bib9","doi-asserted-by":"publisher","first-page":"470","DOI":"10.1016\/j.ajic.2004.10.001","article-title":"A report from the NNIS System. National Nosocomial Infections Surveillance (NNIS) System Report, data summary from January 1992 through June 2004, issued October 2004","volume":"32","year":"2004","journal-title":"Am J Infect Control"},{"key":"key20190807105109648_ref1-bib10","volume-title":"Surveillance of Surgical Site Infections in NHS Hospitals in England, 2011\/2012","author":"Health Protection Agency"},{"key":"key20190807105109648_ref1-bib11","doi-asserted-by":"publisher","first-page":"704","DOI":"10.1016\/j.surg.2007.05.012","article-title":"Surgical site infections after colorectal surgery: do risk factors vary depending on the type of infection considered?","volume":"142","author":"Blumetti","year":"2007","journal-title":"Surgery"},{"key":"key20190807105109648_ref1-bib12","doi-asserted-by":"publisher","first-page":"230","DOI":"10.1016\/j.jhin.2008.04.020","article-title":"Four country healthcare associated infection prevalence survey 2006: overview of the results","volume":"69","author":"Smyth","year":"2008","journal-title":"J Hosp Infect"},{"key":"key20190807105109648_ref1-bib13","volume-title":"Surgical Site Infection \u2013 Prevention and Treatment of Surgical Site Infection","author":"National Institute for Health and Care Excellence (NICE)","year":"2008"},{"key":"key20190807105109648_ref1-bib14","doi-asserted-by":"publisher","first-page":"i2270","DOI":"10.1136\/bmj.i2270","article-title":"Do dressings prevent infection of closed primary wounds after surgery?","volume":"353","author":"Blazeby","year":"2016","journal-title":"BMJ"},{"key":"key20190807105109648_ref1-bib15","volume-title":"Appendix 5: Wound Management Products and Elasticated Garments 2016","author":"British National Formulary"},{"key":"key20190807105109648_ref1-bib16","doi-asserted-by":"publisher","first-page":"1871","DOI":"10.1016\/j.jpedsurg.2004.08.017","article-title":"Pediatric clean surgical wounds: is dressing necessary?","volume":"39","author":"Merei","year":"2004","journal-title":"J Pediatr Surg"},{"key":"key20190807105109648_ref1-bib17","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD003091.pub4","article-title":"Dressings for the prevention of surgical site infection","volume":"12","author":"Dumville","year":"2016","journal-title":"Cochrane Database Syst Rev"},{"key":"key20190807105109648_ref1-bib18","doi-asserted-by":"publisher","first-page":"267","DOI":"10.1053\/jhin.2001.1003","article-title":"Morbidity and mortality associated with surgical site infections: results from the 1997\u20131999 INCISO surveillance","volume":"48","author":"Astagneau","year":"2001","journal-title":"J Hosp Infect"},{"key":"key20190807105109648_ref1-bib19","doi-asserted-by":"publisher","first-page":"160","DOI":"10.1177\/003335490712200205","article-title":"Estimating health care-associated infections and deaths in U.S. hospitals, 2002","volume":"122","author":"Klevens","year":"2007","journal-title":"Public Health Rep"},{"key":"key20190807105109648_ref1-bib20","doi-asserted-by":"publisher","first-page":"720","DOI":"10.1136\/bmj.38232.646227.DE","article-title":"Surgical wound infection as a performance indicator: agreement of common definitions of wound infection in 4773 patients","volume":"329","author":"Wilson","year":"2004","journal-title":"BMJ"},{"key":"key20190807105109648_ref1-bib21","doi-asserted-by":"publisher","first-page":"e276","DOI":"10.1016\/S1473-3099(16)30398-X","article-title":"New WHO recommendations on preoperative measures for surgical site infection prevention: an evidence-based global perspective","volume":"16","author":"Allegranzi","year":"2016","journal-title":"Lancet Infect Dis"},{"key":"key20190807105109648_ref1-bib22","doi-asserted-by":"publisher","first-page":"e288","DOI":"10.1016\/S1473-3099(16)30402-9","article-title":"New WHO recommendations on intraoperative and postoperative measures for surgical site infection prevention: an evidence-based global perspective","volume":"16","author":"Allegranzi","year":"2016","journal-title":"Lancet Infect Dis"},{"key":"key20190807105109648_ref1-bib23","first-page":"27","article-title":"Grounded theory: the discovery of grounded theory","volume":"12","author":"Glaser","year":"1967","journal-title":"Sociology"},{"key":"key20190807105109648_ref1-bib24","volume-title":"Severn and Peninsula Audit and Research Collaborative for Surgeons","author":"Health Education England"},{"key":"key20190807105109648_ref1-bib25","doi-asserted-by":"publisher","first-page":"e165","DOI":"10.1002\/bjs.10432","article-title":"Multicentre observational study of adherence to Sepsis Six guidelines in emergency general surgery","volume":"104","author":"UK National Surgical Research Collaborative","year":"2017","journal-title":"Br J Surg"},{"key":"key20190807105109648_ref1-bib26","doi-asserted-by":"publisher","first-page":"193","DOI":"10.1017\/S0195941700064080","article-title":"CDC guideline for prevention of surgical wound infections, 1985. Supersedes guideline for prevention of surgical wound infections published in 1982. (Originally published in November 1985). Revised","volume":"7","author":"Garner","year":"1986","journal-title":"Infect Control"},{"key":"key20190807105109648_ref1-bib27","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1016\/S0039-6109(16)42031-1","article-title":"The epidemiology of wound infection. A 10-year prospective study of 62,939 wounds","volume":"60","author":"Cruse","year":"1980","journal-title":"Surg Clin North Am"},{"issue":"22","key":"key20190807105109648_ref1-bib28","doi-asserted-by":"publisher","DOI":"10.3310\/hta5220","article-title":"The measurement and monitoring of surgical adverse events","volume":"5","author":"Bruce","year":"2001","journal-title":"Health Technol Assess"},{"key":"key20190807105109648_ref1-bib29","doi-asserted-by":"publisher","first-page":"606","DOI":"10.1017\/S0195941700015241","article-title":"CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections","volume":"13","author":"Horan","year":"1992","journal-title":"Infect Control Hosp Epidemiol"},{"key":"key20190807105109648_ref1-bib30","doi-asserted-by":"publisher","first-page":"311","DOI":"10.1016\/S0140-6736(86)90838-X","article-title":"A scoring method (ASEPSIS) for postoperative wound infections for use in clinical trials of antibiotic prophylaxis","volume":"1","author":"Wilson","year":"1986","journal-title":"Lancet"},{"key":"key20190807105109648_ref1-bib31","unstructured":"PHE. Protocol for the Surveillance of Surgical Site Infection \u2013 Surgical Site Infection Surveillance Service. Version 6. London: PHE; 2013."},{"issue":"30","key":"key20190807105109648_ref1-bib32","doi-asserted-by":"publisher","DOI":"10.3310\/hta15300","article-title":"Identification of risk factors by systematic review and development of risk-adjusted models for surgical site infection","volume":"15","author":"Gibbons","year":"2011","journal-title":"Health Technol Assess"},{"key":"key20190807105109648_ref1-bib33","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD003091.pub2","article-title":"Dressings for the prevention of surgical site infection","volume":"7","author":"Dumville","year":"2011","journal-title":"Cochrane Database Syst Rev"},{"key":"key20190807105109648_ref1-bib34","doi-asserted-by":"publisher","first-page":"1087","DOI":"10.1007\/s11136-010-9677-6","article-title":"PRO development: rigorous qualitative research as the crucial foundation","volume":"19","author":"Lasch","year":"2010","journal-title":"Qual Life Res"},{"key":"key20190807105109648_ref1-bib35","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1007\/BF00434800","article-title":"The European Organization for Research and Treatment of Cancer. Approach to quality of life assessment: guidelines for developing questionnaire modules. EORTC Study Group on Quality of Life","volume":"2","author":"Sprangers","year":"1993","journal-title":"Qual Life Res"},{"key":"key20190807105109648_ref1-bib36","doi-asserted-by":"publisher","first-page":"967","DOI":"10.1016\/j.jval.2011.06.014","article-title":"Content validity \u2013 establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1 \u2013 eliciting concepts for a new PRO instrument","volume":"14","author":"Patrick","year":"2011","journal-title":"Value Health"},{"key":"key20190807105109648_ref1-bib37","doi-asserted-by":"publisher","first-page":"978","DOI":"10.1016\/j.jval.2011.06.013","article-title":"Content validity \u2013 establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2 \u2013 assessing respondent understanding","volume":"14","author":"Patrick","year":"2011","journal-title":"Value Health"},{"key":"key20190807105109648_ref1-bib38","first-page":"273","volume-title":"Handbook of Qualitative Research","author":"Strauss","year":"1994"},{"key":"key20190807105109648_ref1-bib39","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD003091.pub3","article-title":"Dressings for the prevention of surgical site infection","volume":"9","author":"Dumville","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"key20190807105109648_ref1-bib40","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD004287.pub4","article-title":"Tissue adhesives for closure of surgical incisions","volume":"11","author":"Dumville","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"key20190807105109648_ref1-bib41","doi-asserted-by":"publisher","first-page":"114","DOI":"10.1016\/j.jamcollsurg.2010.03.013","article-title":"Use of tissue glue for surgical incision closure: a systematic review and meta-analysis of randomized controlled trials","volume":"211","author":"Chow","year":"2010","journal-title":"J Am Coll Surg"},{"key":"key20190807105109648_ref1-bib42","unstructured":"US Department of Health and Human Services Food and Drug Administration (FDA). Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Silver Spring, MD: FDA; 2009."},{"key":"key20190807105109648_ref1-bib43","doi-asserted-by":"publisher","first-page":"363","DOI":"10.2165\/00019053-200826050-00002","article-title":"Perspectives on patient-reported outcomes: content validity and qualitative research in a changing clinical trial environment","volume":"26","author":"Leidy","year":"2008","journal-title":"PharmacoEconomics"},{"key":"key20190807105109648_ref1-bib44","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1093\/poq\/nfm006","article-title":"Research synthesis: the practice of cognitive interviewing","volume":"71","author":"Beatty","year":"2007","journal-title":"Public Opin Q"},{"key":"key20190807105109648_ref1-bib45","unstructured":"Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. URL: www.medicinescomplete.com (accessed 25 April 2018)."},{"key":"key20190807105109648_ref1-bib46","volume-title":"Statistical Decision Theory","author":"Pratt","year":"2001","edition":"3rd edn."},{"key":"key20190807105109648_ref1-bib47","volume-title":"Guide to the Methods of Technology Appraisal 2013","author":"National Institute for Health and Care Excellence (NICE)","year":"2013"},{"key":"key20190807105109648_ref1-bib48","volume-title":"Surgery and the NHS in Numbers 2013\/14","author":"Royal College of Surgeons"},{"key":"key20190807105109648_ref1-bib49","doi-asserted-by":"publisher","first-page":"1738","DOI":"10.1002\/bjs.10274","article-title":"Feasibility work to inform the design of a randomized clinical trial of wound dressings in elective and unplanned abdominal surgery","volume":"103","author":"SPARCS and WMRC on behalf of the Bluebelle Study Group","year":"2016","journal-title":"Br J Surg"},{"key":"key20190807105109648_ref1-bib50","doi-asserted-by":"publisher","first-page":"24","DOI":"10.1016\/j.jhin.2013.09.012","article-title":"Clinical and economic burden of surgical site infection (SSI) and predicted financial consequences of elimination of SSI from an English hospital","volume":"86","author":"Jenks","year":"2014","journal-title":"J Hosp Infect"},{"key":"key20190807105109648_ref1-bib51","unstructured":"PHE. Surveillance of Surgical Site Infections in NHS Hospitals in England 2014\u201315. London: PHE; 2015. URL: www.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/484874\/Surveillance_of_Surgical_Site_Infections_in_NHS_Hospitals_in_England_report_2014-15.pdf (accessed 25 April 2018)."},{"key":"key20190807105109648_ref1-bib52","unstructured":"Office for National Statistics. ONS Consumer Price Index: Medical Services. Newport: Office for National Statistics; 2016."},{"key":"key20190807105109648_ref1-bib53","volume-title":"Unit Costs of Health and Social Care 2015","author":"Curtis","year":"2015"},{"key":"key20190807105109648_ref1-bib54","doi-asserted-by":"publisher","first-page":"1126","DOI":"10.1016\/j.jval.2015.08.004","article-title":"Health utility values associated with surgical site infection: a systematic review","volume":"18","author":"Gheorghe","year":"2015","journal-title":"Value Health"},{"key":"key20190807105109648_ref1-bib55","doi-asserted-by":"publisher","first-page":"183","DOI":"10.1086\/502033","article-title":"The impact of surgical-site infections following orthopedic surgery at a community hospital and a university hospital: adverse quality of life, excess length of stay, and extra cost","volume":"23","author":"Whitehouse","year":"2002","journal-title":"Infect Control Hosp Epidemiol"},{"key":"key20190807105109648_ref1-bib56","doi-asserted-by":"publisher","first-page":"399","DOI":"10.3171\/2011.5.SPINE10825","article-title":"Effect of deep wound infection following lumbar arthrodesis for degenerative disc disease on long-term outcome: a prospective study: clinical article","volume":"15","author":"Falavigna","year":"2011","journal-title":"J Neurosurg Spine"},{"key":"key20190807105109648_ref1-bib57","first-page":"5","article-title":"Development of a single, practical measure of surgical site infection (SSI) for patient self-report or observer completion","volume":"16","author":"Macefield","year":"2015","journal-title":"J Infect Prev"},{"key":"key20190807105109648_ref1-bib58","doi-asserted-by":"publisher","first-page":"337","DOI":"10.3109\/07853890109002087","article-title":"EQ-5D: a measure of health status from the EuroQol Group","volume":"33","author":"Rabin","year":"2001","journal-title":"Ann Med"},{"key":"key20190807105109648_ref1-bib59","unstructured":"Department of Health and Social Care. National Schedules of Reference Costs: The Main Schedule. London: Department of Health and Social Care; 2016."},{"key":"key20190807105109648_ref1-bib60","unstructured":"Joint Formulary Committee. British National Formulary. [70 ed]. London: BMJ Group and Pharmaceutical Press; 2016."},{"key":"key20190807105109648_ref1-bib61","volume-title":"Unit Costs of Health and Social Care 2016","author":"Curtis","year":"2016"},{"key":"key20190807105109648_ref1-bib62","doi-asserted-by":"publisher","first-page":"670","DOI":"10.1136\/bmj.319.7211.670","article-title":"What is meant by intention to treat analysis? Survey of published randomised controlled trials","volume":"319","author":"Hollis","year":"1999","journal-title":"BMJ"},{"key":"key20190807105109648_ref1-bib63","doi-asserted-by":"publisher","first-page":"3219","DOI":"10.1002\/1097-0258(20001215)19:23<3219::AID-SIM623>3.0.CO;2-P","article-title":"Analysis of cost data in randomized trials: an application of the non-parametric bootstrap","volume":"19","author":"Barber","year":"2000","journal-title":"Stat Med"},{"key":"key20190807105109648_ref1-bib64","volume-title":"Economic Evaluation in Clinical Trials","author":"Glick","year":"2007"},{"key":"key20190807105109648_ref1-bib65","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1002\/hec.766","article-title":"Missing.. presumed at random: cost-analysis of incomplete data","volume":"12","author":"Briggs","year":"2003","journal-title":"Health Econ"},{"key":"key20190807105109648_ref1-bib66","doi-asserted-by":"crossref","DOI":"10.1002\/9781119013563","volume-title":"Statistical Analysis with Missing Data","author":"Little","year":"2002"},{"key":"key20190807105109648_ref1-bib67","doi-asserted-by":"publisher","first-page":"283","DOI":"10.1186\/s13063-016-1391-4","article-title":"Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI)","volume":"17","author":"Donovan","year":"2016","journal-title":"Trials"},{"key":"key20190807105109648_ref1-bib68","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","article-title":"Research electronic data capture (REDCap) \u2013 a metadata-driven methodology and workflow process for providing translational research informatics support","volume":"42","author":"Harris","year":"2009","journal-title":"J Biomed Inform"},{"key":"key20190807105109648_ref1-bib69","doi-asserted-by":"crossref","DOI":"10.1017\/CBO9780511996214","volume-title":"Measurement in Medicine: A Practical Guide","author":"de Vet","year":"2011"},{"key":"key20190807105109648_ref1-bib70","volume-title":"Quality of Life: Assessment, Analysis and Interpretation","author":"Fayers"},{"key":"key20190807105109648_ref1-bib71","doi-asserted-by":"publisher","first-page":"e012635","DOI":"10.1136\/bmjopen-2016-012635","article-title":"Bluebelle study (phase A): a mixed-methods feasibility study to inform an RCT of surgical wound dressing strategies","volume":"6","author":"The Bluebelle Study Group, the Severn and Peninsula Audit and Research Collaborative for Surgeons, and the West Midlands Research Collaborative","year":"2016","journal-title":"BMJ Open"},{"key":"key20190807105109648_ref1-bib72","doi-asserted-by":"publisher","first-page":"170","DOI":"10.1177\/1757177416689724","article-title":"Development of a single, practical measure of surgical site infection (SSI) for patient report or observer completion","volume":"18","author":"Macefield","year":"2017","journal-title":"J Infect Prev"},{"key":"key20190807105109648_ref1-bib73","doi-asserted-by":"publisher","first-page":"703","DOI":"10.1016\/j.otohns.2009.01.003","article-title":"Randomized trial of tissue adhesive vs staples in thyroidectomy integrating patient satisfaction and Manchester score","volume":"140","author":"Amin","year":"2009","journal-title":"Otolaryngol Head Neck Surg"},{"key":"key20190807105109648_ref1-bib74","first-page":"117","article-title":"2-octylcyanoacrylate tissue adhesive versus polypropylene suture for skin closure of Pfannenstiel incision","volume":"6","author":"Av\u015far","year":"2009","journal-title":"J Turk Soc Obstet Gynecol"},{"key":"key20190807105109648_ref1-bib75","doi-asserted-by":"publisher","first-page":"307","DOI":"10.1016\/j.amjsurg.2004.04.006","article-title":"Closure of long surgical incisions with a new formulation of 2-octylcyanoacrylate tissue adhesive versus commercially available methods","volume":"188","author":"Blondeel","year":"2004","journal-title":"Am J Surg"},{"key":"key20190807105109648_ref1-bib76","doi-asserted-by":"publisher","first-page":"84","DOI":"10.1016\/j.jtv.2012.04.002","article-title":"A prospective randomised study comparing the jubilee dressing method to a standard adhesive dressing for total hip and knee replacements","volume":"21","author":"Burke","year":"2012","journal-title":"J Tissue Viability"},{"key":"key20190807105109648_ref1-bib77","doi-asserted-by":"publisher","first-page":"535","DOI":"10.1016\/j.jocn.2008.08.004","article-title":"Use of skin glue versus traditional wound closure methods in brain surgery: a prospective, randomized, controlled study","volume":"16","author":"Chibbaro","year":"2009","journal-title":"J Clin Neurosci"},{"key":"key20190807105109648_ref1-bib78","doi-asserted-by":"publisher","first-page":"27","DOI":"10.12968\/jowc.2005.14.1.26722","article-title":"Choice of dressing has a major impact on blistering and healing outcomes in orthopaedic patients","volume":"14","author":"Cosker","year":"2005","journal-title":"J Wound Care"},{"key":"key20190807105109648_ref1-bib79","doi-asserted-by":"publisher","first-page":"146","DOI":"10.1097\/00129689-200606000-00005","article-title":"A prospective, randomized controlled trial comparing n-butyl cyanoacrylate tissue adhesive (LiquiBand) with sutures for skin closure after laparoscopic general surgical procedures","volume":"16","author":"Dowson","year":"2006","journal-title":"Surg Laparosc Endosc Percutan Tech"},{"key":"key20190807105109648_ref1-bib80","doi-asserted-by":"publisher","first-page":"593","DOI":"10.1016\/j.surg.2004.02.015","article-title":"A prospective, randomized, controlled clinical trial of tissue adhesive (2-octylcyanoacrylate) versus standard wound closure in breast surgery","volume":"136","author":"Gennari","year":"2004","journal-title":"Surgery"},{"key":"key20190807105109648_ref1-bib81","doi-asserted-by":"publisher","first-page":"292","DOI":"10.1001\/archfaci.1.4.292","article-title":"Efficacy of octyl-2-cyanoacrylate tissue glue in blepharoplasty. A prospective controlled study of wound-healing characteristics","volume":"1","author":"Greene","year":"1999","journal-title":"Arch Facial Plast Surg"},{"key":"key20190807105109648_ref1-bib82","doi-asserted-by":"publisher","first-page":"179","DOI":"10.1080\/110241598750004616","article-title":"Effects of occlusive and conventional gauze dressings on incisional healing after abdominal operations","volume":"164","author":"Holm","year":"1998","journal-title":"Eur J Surg"},{"key":"key20190807105109648_ref1-bib83","doi-asserted-by":"publisher","first-page":"252","DOI":"10.1016\/j.jmig.2013.10.003","article-title":"A prospective, randomized, controlled, double-masked, multi-center clinical trial of medical adhesives for the closure of laparoscopic incisions","volume":"21","author":"Kent","year":"2014","journal-title":"J Minim Invasive Gynecol"},{"key":"key20190807105109648_ref1-bib84","first-page":"122","article-title":"A clinical trial of tissue adhesive (histoacryl) in skin closure of groin wounds","volume":"44","author":"Keng","year":"1989","journal-title":"Med J Malaysia"},{"key":"key20190807105109648_ref1-bib85","doi-asserted-by":"publisher","first-page":"238","DOI":"10.1302\/0301-620X.88B2.16923","article-title":"A comparison of three methods of wound closure following arthroplasty: a prospective, randomised, controlled trial","volume":"88","author":"Khan","year":"2006","journal-title":"J Bone Joint Surg Br"},{"key":"key20190807105109648_ref1-bib86","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1136\/pgmj.63.735.27","article-title":"Exposure of the wound \u2013 a safe economy in the NHS","volume":"63","author":"Law","year":"1987","journal-title":"Postgrad Med J"},{"key":"key20190807105109648_ref1-bib87","doi-asserted-by":"publisher","first-page":"716","DOI":"10.1046\/j.1445-2197.2002.02529.x","article-title":"Wound blisters post hip surgery: a prospective trial comparing dressings","volume":"72","author":"Lawrentschuk","year":"2002","journal-title":"ANZ J Surg"},{"key":"key20190807105109648_ref1-bib88","doi-asserted-by":"publisher","first-page":"725","DOI":"10.1302\/0301-620X.91B6.21831","article-title":"Skin closure after total hip replacement","volume":"91-B","author":"Livesey","year":"2009","journal-title":"J Bone Joint Surg"},{"key":"key20190807105109648_ref1-bib89","doi-asserted-by":"publisher","first-page":"57","DOI":"10.1097\/00000637-199401000-00011","article-title":"Influence of occlusive and impregnated gauze dressings on incisional healing: a prospective, randomized, controlled study","volume":"32","author":"Michie","year":"1994","journal-title":"Ann Plast Surg"},{"key":"key20190807105109648_ref1-bib90","doi-asserted-by":"publisher","first-page":"553","DOI":"10.1007\/s00383-002-0728-0","article-title":"Comparing wound closure using tissue glue versus subcuticular suture for pediatric surgical incisions: a prospective, randomised trial","volume":"18","author":"Ong","year":"2002","journal-title":"Pediatr Surg Int"},{"key":"key20190807105109648_ref1-bib91","doi-asserted-by":"publisher","first-page":"103","DOI":"10.1007\/s00238-010-0477-6","article-title":"Closure of cutaneous incision after thyroid surgery: a comparison between metal clips and cutaneous octyl-2-cyanoacrylate adhesive. A prospective randomized clinical trial","volume":"34","author":"Pronio","year":"2011","journal-title":"Eur J Plast Surg"},{"key":"key20190807105109648_ref1-bib92","doi-asserted-by":"publisher","first-page":"136","DOI":"10.12968\/jowc.2011.20.3.136","article-title":"Randomised clinical trial comparing Hydrofiber and alginate dressings post-hip replacement","volume":"20","author":"Ravnskog","year":"2011","journal-title":"J Wound Care"},{"key":"key20190807105109648_ref1-bib93","doi-asserted-by":"publisher","first-page":"159","DOI":"10.1055\/s-0030-1270458","article-title":"Prospective, randomized, controlled trial comparing a tissue adhesive (Dermabond) with adhesive strips (Steri-Strips) for the closure of laparoscopic trocar wounds in children","volume":"21","author":"Romero","year":"2011","journal-title":"Eur J Ped Surg"},{"key":"key20190807105109648_ref1-bib94","first-page":"877","article-title":"Prospective randomized blind controlled trial comparing sutures, tape, and octylcyanoacrylate tissue adhesive for skin closure after phlebectomy","volume":"27","author":"Shamiyeh","year":"2001","journal-title":"Dermatol Surg"},{"key":"key20190807105109648_ref1-bib95","first-page":"966","article-title":"A randomized controlled trial of high-viscosity 2-octyl cyanoacrylate tissue adhesive versus sutures in repairing facial wounds following Mohs micrographic surgery","volume":"33","author":"Sniezek","year":"2007","journal-title":"Dermatol Surg"},{"key":"key20190807105109648_ref1-bib96","doi-asserted-by":"publisher","first-page":"624","DOI":"10.1111\/j.1524-475X.2007.00294.x","article-title":"Moist wound healing compared with standard care of treatment of primary closed vascular surgical wounds: a prospective randomized controlled study","volume":"15","author":"Vogt","year":"2007","journal-title":"Wound Repair Regen"},{"key":"key20190807105109648_ref1-bib97","doi-asserted-by":"publisher","first-page":"312","DOI":"10.1097\/00006199-199509000-00009","article-title":"A comparison of three wound dressings in patients undergoing heart surgery","volume":"44","author":"Wikblad","year":"1995","journal-title":"Nurs Res"},{"key":"key20190807105109648_ref1-bib98","doi-asserted-by":"publisher","first-page":"43","DOI":"10.1378\/chest.125.1.43","article-title":"Effect of three wound dressings on infection, healing comfort, and cost in patients with sternotomy wounds: a randomized trial","volume":"125","author":"Wynne","year":"2004","journal-title":"Chest"},{"key":"key20190807105109648_ref1-bib99","doi-asserted-by":"publisher","first-page":"256","DOI":"10.1097\/00004630-199005000-00014","article-title":"Rating the burn scar","volume":"11","author":"Sullivan","year":"1990","journal-title":"J Burn Care Rehabil"},{"key":"key20190807105109648_ref1-bib100","doi-asserted-by":"publisher","first-page":"675","DOI":"10.1016\/S0196-0644(95)70183-4","article-title":"Wound registry: development and validation","volume":"25","author":"Hollander","year":"1995","journal-title":"Ann Emerg Med"},{"key":"key20190807105109648_ref1-bib101","doi-asserted-by":"publisher","first-page":"e016155","DOI":"10.1136\/bmjopen-2017-016155","article-title":"Developing outcome measures assessing wound management and patient experience: a mixed methods study","volume":"7","author":"Elliott","year":"2017","journal-title":"BMJ Open"},{"key":"key20190807105109648_ref1-bib102","volume-title":"Consent and Request Form for Medical Photographs\/Video Recordings","author":"University Hospitals Bristol NHS Foundation Trust"},{"issue":"6","key":"key20190807105109648_ref1-bib103","doi-asserted-by":"crossref","DOI":"10.3310\/hta3060","article-title":"Assessing the costs of healthcare technologies in clinical trials","volume":"3","author":"Johnston","year":"1999","journal-title":"Health Technol Assess"},{"key":"key20190807105109648_ref1-bib104","doi-asserted-by":"publisher","first-page":"705","DOI":"10.1017\/S026646230200051X","article-title":"The accuracy of self-reported healthcare resource utilization in health economic studies","volume":"18","author":"Petrou","year":"2002","journal-title":"Int J Technol Assess Health Care"},{"key":"key20190807105109648_ref1-bib105","doi-asserted-by":"publisher","first-page":"6209","DOI":"10.1002\/sim.3436","article-title":"A group-sequential design for clinical trials with treatment selection","volume":"27","author":"Stallard","year":"2008","journal-title":"Stat Med"},{"key":"key20190807105109648_ref1-bib106","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1186\/1745-6215-10-39","article-title":"Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial","volume":"10","author":"Sydes","year":"2009","journal-title":"Trials"},{"key":"key20190807105109648_ref1-bib107","doi-asserted-by":"publisher","first-page":"1183","DOI":"10.1136\/bmj.324.7347.1183","article-title":"Increasing response rates to postal questionnaires: systematic review","volume":"324","author":"Edwards","year":"2002","journal-title":"BMJ"},{"key":"key20190807105109648_ref1-bib108","doi-asserted-by":"publisher","first-page":"e003821","DOI":"10.1136\/bmjopen-2013-003821","article-title":"Strategies to improve retention in randomised trials: a Cochrane systematic review and meta-analysis","volume":"4","author":"Brueton","year":"2014","journal-title":"BMJ Open"},{"key":"key20190807105109648_ref1-bib109","doi-asserted-by":"publisher","first-page":"119","DOI":"10.1016\/S0195-6701(98)90325-5","article-title":"Comparison of wound scoring methods for use in audit","volume":"39","author":"Wilson","year":"1998","journal-title":"J Hosp Infect"},{"key":"key20190807105109648_ref1-bib110","doi-asserted-by":"publisher","first-page":"529","DOI":"10.1007\/s00266-013-0123-3","article-title":"Use of 2-octyl cyanoacrylate together with a self-adhering mesh (Dermabond TM Prineo TM) for skin closure following abdominoplasty: an open, prospective, controlled, randomized, clinical study","volume":"37","author":"Parvizi","year":"2013","journal-title":"Aesthet Plast Surg"},{"key":"key20190807105109648_ref1-bib111","first-page":"219","article-title":"Role of \u2019polyurethane membrane\u2019 in post operative wound management","volume":"33","author":"Gardezi","year":"1983","journal-title":"J Pak Med Assoc"},{"key":"key20190807105109648_ref1-bib112","first-page":"46","article-title":"The transparent adhesive drape as post-operative dressing \u2013 a randomised clinical study for comparison with a conventional dressing","volume":"52","author":"Rohde","year":"1981","journal-title":"Der Chirurg"},{"key":"key20190807105109648_ref1-bib113","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/S1015-9584(08)60046-9","article-title":"Prospective evaluation of occlusive hydrocolloid dressing regarding the healing effect after abdominal operations: randomised controlled trial","volume":"31","author":"Shinohara","year":"2008","journal-title":"As J Surg"},{"key":"key20190807105109648_ref1-bib114","first-page":"791","article-title":"To dress or not to dress surgical wounds? Patients\u2019 attitudes to wound care after major abdominal operations","volume":"161","author":"Persson","year":"1995","journal-title":"Eur J Surg"},{"key":"key20190807105109648_ref1-bib115","doi-asserted-by":"publisher","first-page":"424","DOI":"10.1016\/j.jamcollsurg.2015.04.019","article-title":"Total occlusive ionic silver-containing dressing vs mupirocin ointment application vs conventional dressing in elective colorectal surgery: effect on incisional surgical site infection","volume":"221","author":"Ruiz-Tovar","year":"2015","journal-title":"J Am Coll Surg"},{"key":"key20190807105109648_ref1-bib116","first-page":"10","article-title":"Wound dressing in major head and neck cancer surgery: a prospective randomised study of gauze dressing vs sterile vaseline ointment","volume":"19","author":"Phan","year":"1993","journal-title":"Eur J Surg Oncol"},{"key":"key20190807105109648_ref1-bib117","first-page":"56","article-title":"Surgical site infections. Effectiveness of polyhexamethylene biguanide wound dressings","volume":"23","author":"Martin-Trapero","year":"2013","journal-title":"Enferm Clin"},{"key":"key20190807105109648_ref1-bib118","doi-asserted-by":"publisher","first-page":"337","DOI":"10.1016\/j.ajog.2012.10.141","article-title":"Silver ion-eluting dressings for prevention of post cesarean wound infection: a randomized, controlled trial","volume":"208","author":"Bennett","year":"2013","journal-title":"Am J Obstet Gynecol"},{"key":"key20190807105109648_ref1-bib119","unstructured":"De Win M, De Blaere X, Scheers R. The Effect of Choice of Surgical Wound Dressing on the Direct Cost of Healing. Eighth European Conference on Advances in Wound Management, 26\u201328 April 1998, Madrid, Spain."},{"key":"key20190807105109648_ref1-bib120","volume-title":"A Randomized, Prospective Study of Surgical Site Infections Following Vascular Reconstructive Surgery: Untreated vs. Silver-impregnated Dressings","author":"Politano"},{"key":"key20190807105109648_ref1-bib121","doi-asserted-by":"publisher","first-page":"419","DOI":"10.1016\/j.jvs.2014.07.034","article-title":"Prospective, randomized, multi-institutional clinical trial of a silver alginate dressing to reduce lower extremity vascular surgery wound complications","volume":"61","author":"Ozaki","year":"2015","journal-title":"J Vasc Surg"},{"key":"key20190807105109648_ref1-bib122","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1002\/hec.3564","article-title":"Valuing health-related quality of life: an EQ-5D-5L value set for England","volume":"27","author":"Devlin","year":"2016","journal-title":"Health Econ"}],"container-title":["Health Technology Assessment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/publications\/hta23390\/hta23390.xml","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2009586","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/publications\/hta23390\/hta23390.xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2029857","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,15]],"date-time":"2023-08-15T15:28:30Z","timestamp":1692113310000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/hta\/hta23390"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,8]]},"references-count":122,"journal-issue":{"issue":"39","published-online":{"date-parts":[[2019,8]]}},"alternative-id":["10.3310\/hta23390"],"URL":"https:\/\/doi.org\/10.3310\/hta23390","relation":{},"ISSN":["1366-5278","2046-4924"],"issn-type":[{"value":"1366-5278","type":"print"},{"value":"2046-4924","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,8]]},"assertion":[{"value":"This content has been made freely available to all.","name":"free","label":"Free to read"}]}}