{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T22:17:12Z","timestamp":1791929832092,"version":"4.3.4"},"reference-count":20,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2019,3,12]],"date-time":"2019-03-12T00:00:00Z","timestamp":1552348800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"MiMedx Group Inc."}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["International Wound Journal"],"published-print":{"date-parts":[[2019,6]]},"abstract":"<jats:p>\n                    Statistical interpretation of data collected in a randomised controlled trial (RCT) is conducted on the intention\u2010to\u2010treat (ITT) and\/or the per\u2010protocol (PP) study populations. ITT analysis is a comparison of treatment groups including all patients as originally allocated after randomisation regardless if treatment was initiated or completed. PP analysis is a comparison of treatment groups including only those patients who completed the treatment as originally allocated, although it is often criticised because of its potential to instil bias. A previous report from an RCT conducted to evaluate the efficacy of dehydrated human amnion\/chorion membrane allograft (EpiFix) as an adjunct to standard comprehensive wound therapy consisting of moist dressings and multi\u2010layer compression in the healing of venous leg ulcers (VLUs) only reported PP study results (n\u2009=\u2009109, 52 EpiFix and 57 standard care patients), although there were 128 patients randomised: 64 to the EpiFix group and 64 to the standard care group. Primary study outcome was the incidence of healing at 12\u2009weeks. The purpose of the present study is to report ITT results on all 128 randomised subjects and assess if both ITT and PP data analyses arrive at the same conclusion of the efficacy of EpiFix as a treatment for VLU. Rates of healing for the ITT and PP populations were, respectively, 50% and 60% for those receiving EpiFix and 31% and 35% for those in the standard care cohort. Within both ITT and PP analyses, these differences were statistically significant;\n                    <jats:italic>P<\/jats:italic>\n                    = 0.0473, ITT and\n                    <jats:italic>P<\/jats:italic>\n                    = 0.0128, PP. The Kaplan\u2010Meier plot of time to heal within 12\u2009weeks for the ITT and PP populations demonstrated a superior wound\u2010healing trajectory for EpiFix compared with VLUs treated with standard care alone. These data provide clinicians and health policymakers an additional level of assurance regarding the effectiveness of EpiFix.\n                  <\/jats:p>","DOI":"10.1111\/iwj.13094","type":"journal-article","created":{"date-parts":[[2019,3,12]],"date-time":"2019-03-12T20:39:34Z","timestamp":1552423174000},"page":"761-767","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Variations in study outcomes relative to intention\u2010to\u2010treat and per\u2010protocol data analysis techniques in the evaluation of efficacy for treatment of venous leg ulcers with dehydrated human amnion\/chorion membrane allograft"],"prefix":"10.1111","volume":"16","author":[{"given":"Christian","family":"Bianchi","sequence":"first","affiliation":[{"name":"Department of Surgery Loma Linda Veterans Affairs Healthcare System  Loma Linda California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Tettelbach","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs MiMedx Group, Inc.  Marietta Georgia"},{"name":"Department of Anesthesiology Duke University School of Medicine  Durham North Carolina"},{"name":"Department of Internal Medicine Landmark Hospital  Salt Lake City Utah"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niki","family":"Istwan","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs Istwan Consulting Services  Prescott Arizona"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brandon","family":"Hubbs","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs MiMedx Group, Inc.  Marietta Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly","family":"Kot","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs MiMedx Group, Inc.  Marietta Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stan","family":"Harris","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs MiMedx Group, Inc.  Marietta Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donald","family":"Fetterolf","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs MiMedx Group, Inc.  Marietta Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,3,12]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-319-01812-6_24"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/clc.4960220106"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.312.7023.71"},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMms1604593"},{"key":"e_1_2_5_6_1","unstructured":"U.S. Food and Drug Administration.E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials;2017.https:\/\/www.federalregister.gov\/documents\/2017\/10\/31\/2017\u201023613\/e9r1\u2010statistical\u2010principles\u2010for\u2010clinical\u2010trials\u2010addendum\u2010estimands\u2010and\u2010sensitivity\u2010analysis\u2010in. Accessed July 30 2018."},{"key":"e_1_2_5_7_1","doi-asserted-by":"publisher","DOI":"10.4103\/2229-3485.83221"},{"key":"e_1_2_5_8_1","unstructured":"U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER).Guidance for Industry E9 Statistical Principles for Clinical Trials;1998.http:\/\/www.fda.gov\/cber\/guidelines.htm. Accessed July 30 2018."},{"key":"e_1_2_5_9_1","doi-asserted-by":"crossref","unstructured":"GluudLL. Bias in clinical intervention research.Am J Epidemiol.2006;163:493\u2010501.","DOI":"10.1093\/aje\/kwj069"},{"key":"e_1_2_5_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12843"},{"key":"e_1_2_5_11_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1000251"},{"key":"e_1_2_5_12_1","doi-asserted-by":"publisher","DOI":"10.4103\/2229-3485.184823"},{"key":"e_1_2_5_13_1","doi-asserted-by":"publisher","DOI":"10.4103\/0974-1208.82352"},{"issue":"1","key":"e_1_2_5_14_1","first-page":"10","article-title":"Wound care outcomes and associated costs among patients treated in US outpatient wound centers: data from the US wound registry","volume":"24","author":"Fife CE","year":"2012","journal-title":"Wounds"},{"key":"e_1_2_5_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/PRS.0b013e3181de24bc"},{"key":"e_1_2_5_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/9781118458167"},{"key":"e_1_2_5_17_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.2002.01628.x"},{"key":"e_1_2_5_18_1","doi-asserted-by":"publisher","DOI":"10.18773\/austprescr.2015.001"},{"key":"e_1_2_5_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.317.7154.291"},{"key":"e_1_2_5_20_1","volume-title":"Chronic Venous Ulcers: A Comparative Effectiveness Review of Treatment Modalities","author":"Zenilman J","year":"2013"},{"key":"e_1_2_5_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1346-8138.1998.tb02510.x"}],"container-title":["International Wound Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fiwj.13094","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/iwj.13094","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/iwj.13094","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/iwj.13094","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,18]],"date-time":"2025-04-18T22:14:36Z","timestamp":1745014476000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/iwj.13094"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,3,12]]},"references-count":20,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2019,6]]}},"alternative-id":["10.1111\/iwj.13094"],"URL":"https:\/\/doi.org\/10.1111\/iwj.13094","archive":["Portico"],"relation":{},"ISSN":["1742-4801","1742-481X"],"issn-type":[{"value":"1742-4801","type":"print"},{"value":"1742-481X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,3,12]]},"assertion":[{"value":"2018-12-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-01-21","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-03-12","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}