{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T01:37:19Z","timestamp":1771378639079,"version":"3.50.1"},"reference-count":36,"publisher":"American Medical Association (AMA)","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"Importance<\/jats:title>Antibiotic irrigation of breast implants is widely used internationally, but no clinical study has investigated the pharmacokinetics of antibiotic prophylaxis in the breast implant pocket.<\/jats:p><\/jats:sec>Objectives<\/jats:title>To evaluate how long locally applied gentamicin, cefazolin, and vancomycin concentrations in the implant pocket remain above the minimum inhibitory concentration (MIC) for the most common bacterial infections and to measure systemic uptake.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>This prospective cohort study was performed at the Department of Plastic Surgery and Burns Treatment, Rigshospitalet, Copenhagen, Denmark, between October 25, 2021, and September 22, 2022, among 40 patients undergoing implant-based breast reconstruction who were part of the ongoing BREAST-AB trial (Prophylactic Treatment of Breast Implants With a Solution of Gentamicin, Vancomycin and Cefazolin Antibiotics for Women Undergoing Breast Reconstructive Surgery: a Randomized Controlled Trial). Patients were randomized to receive locally applied gentamicin, cefazolin, and vancomycin or placebo. Samples were obtained from the surgical breast drain and blood up to 10 days postoperatively.<\/jats:p><\/jats:sec>Exposures<\/jats:title>The breast implant and the implant pocket were irrigated with 160 \u03bcg\/mL of gentamicin, 2000 \u03bcg\/mL of cefazolin, and 2000 \u03bcg\/mL of vancomycin in a 200-mL saline solution.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>The primary outcome was the duration of antibiotic concentrations above the MIC breakpoint for Staphylococcus aureus<\/jats:italic> according to the Clinical and Laboratory Standards Institute: gentamicin, 4 \u03bcg\/mL; cefazolin, 2 \u03bcg\/mL; and vancomycin, 2 \u03bcg\/mL. Secondary outcomes included the time above the MIC for Pseudomonas aeruginosa<\/jats:italic> and other relevant bacteria, as well as systemic uptake.<\/jats:p><\/jats:sec>Results<\/jats:title>The study included 40 patients (median age, 44.6 years [IQR, 38.3-51.4 years]; median body mass index, 23.9 [IQR, 21.7-25.9]) with a median number of 3 drain samples (range, 1-10 drain samples) and 2 blood samples (range, 0-6 blood samples). Vancomycin and cefazolin remained above the MIC for S aureus<\/jats:italic> significantly longer than gentamicin (gentamicin, 0.9 days [95% CI, 0.5-1.2 days] for blood samples vs 6.9 days [95% CI, 2.9 to 10.9 days] for vancomycin [P<\/jats:italic>\u2009=\u2009.02] vs 3.7 days [95% CI, 2.2-5.2 days] for cefazolin [P<\/jats:italic>\u2009=\u2009.002]). The gentamicin level remained above the MIC for P aeruginosa<\/jats:italic> for 1.3 days (95% CI, 1.0-1.5 days). Only cefazolin was detectable in blood samples, albeit in very low concentrations (median concentration, 0.04 \u03bcg\/mL [range, 0.007-0.1 \u03bcg\/mL]).<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>This study suggests that patients treated with triple-antibiotic implant irrigation during breast reconstruction receive adequate prophylaxis for S aureus<\/jats:italic> and other common implant-associated, gram-positive bacteria. However, the protection against P aeruginosa<\/jats:italic> may be inadequate.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2023.48414","type":"journal-article","created":{"date-parts":[[2023,12,19]],"date-time":"2023-12-19T16:01:13Z","timestamp":1703001673000},"page":"e2348414","source":"Crossref","is-referenced-by-count":6,"title":["Pharmacokinetics of Locally Applied Antibiotic Prophylaxis for Implant-Based Breast Reconstruction"],"prefix":"10.1001","volume":"6","author":[{"given":"Mathilde Nejrup","family":"Hemmingsen","sequence":"first","affiliation":[{"name":"Department of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne Karen","family":"Bennedsen","sequence":"additional","affiliation":[{"name":"Department of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Randa Bismark","family":"Kullab","sequence":"additional","affiliation":[{"name":"Department of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caroline Barskov","family":"Norlin","sequence":"additional","affiliation":[{"name":"Department of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mathias","family":"\u00d8rholt","sequence":"additional","affiliation":[{"name":"Department of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas","family":"Larsen","sequence":"additional","affiliation":[{"name":"Department of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mats","family":"Bue","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark"},{"name":"Department of Clinical Medicine, Aarhus University, Aarhus, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mads","family":"Lichtenberg","sequence":"additional","affiliation":[{"name":"Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frederik Boetius","family":"Hertz","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tine Engberg","family":"Damsgaard","sequence":"additional","affiliation":[{"name":"Department of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Vester-Glowinski","sequence":"additional","affiliation":[{"name":"Department of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S\u00f8ren Johannes","family":"S\u00f8rensen","sequence":"additional","affiliation":[{"name":"Section of Microbiology, Department of Biology, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Bjarnsholt","sequence":"additional","affiliation":[{"name":"Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark"},{"name":"Department of Clinical Microbiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mikkel","family":"Herly","sequence":"additional","affiliation":[{"name":"Department of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"},{"name":"Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"10","published-online":{"date-parts":[[2023,12,19]]},"reference":[{"issue":"6","key":"zoi231411r2","doi-asserted-by":"publisher","first-page":"524","DOI":"10.3322\/caac.v72.6","article-title":"Breast cancer statistics, 2022.","volume":"72","author":"Giaquinto","year":"2022","journal-title":"CA Cancer J Clin"},{"issue":"1","key":"zoi231411r3","doi-asserted-by":"publisher","first-page":"15","DOI":"10.1097\/PRS.0b013e3182729cde","article-title":"A paradigm shift in U.S. breast reconstruction: increasing implant rates.","volume":"131","author":"Albornoz","year":"2013","journal-title":"Plast Reconstr Surg"},{"issue":"1","key":"zoi231411r4","doi-asserted-by":"publisher","first-page":"30","DOI":"10.1097\/SLA.0000000000002990","article-title":"US FDA breast implant postapproval studies: long-term outcomes in 99,993 patients.","volume":"269","author":"Coroneos","year":"2019","journal-title":"Ann Surg"},{"issue":"4S","key":"zoi231411r5","doi-asserted-by":"publisher","first-page":"7S","DOI":"10.1097\/PRS.0000000000004350","article-title":"Ten-year Core Study data for Sientra\u2019s Food and Drug Administration\u2013approved round and shaped breast implants with cohesive silicone gel.","volume":"141","author":"Stevens","year":"2018","journal-title":"Plast Reconstr Surg"},{"issue":"5","key":"zoi231411r6","doi-asserted-by":"publisher","first-page":"344","DOI":"10.3109\/2000656X.2012.700025","article-title":"Immediate breast reconstruction: a retrospective study with emphasis on complications and risk factors.","volume":"46","author":"Petersen","year":"2012","journal-title":"J Plast Surg Hand Surg"},{"issue":"2","key":"zoi231411r7","doi-asserted-by":"publisher","first-page":"251","DOI":"10.1016\/S1470-2045(16)30668-4","article-title":"Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial.","volume":"18","author":"Dikmans","year":"2017","journal-title":"Lancet Oncol"},{"issue":"2","key":"zoi231411r8","doi-asserted-by":"publisher","first-page":"145","DOI":"10.1093\/asj\/sju084","article-title":"Ten-year results from the Natrelle 410 anatomical form-stable silicone breast implant core study.","volume":"35","author":"Maxwell","year":"2015","journal-title":"Aesthet Surg J"},{"issue":"2","key":"zoi231411r9","doi-asserted-by":"publisher","first-page":"94","DOI":"10.1016\/S1473-3099(05)70084-0","article-title":"Infection in breast implants.","volume":"5","author":"Pittet","year":"2005","journal-title":"Lancet Infect Dis"},{"issue":"22","key":"zoi231411r10","doi-asserted-by":"publisher","first-page":"2682","DOI":"10.1001\/jama.299.22.2682","article-title":"Biofilms and chronic infections.","volume":"299","author":"Wolcott","year":"2008","journal-title":"JAMA"},{"issue":"136","key":"zoi231411r11","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1111\/apm.2013.121.issue-s136","article-title":"The role of bacterial biofilms in chronic infections.","volume":"121","author":"Bjarnsholt","year":"2013","journal-title":"APMIS Suppl"},{"issue":"7","key":"zoi231411r12","doi-asserted-by":"publisher","first-page":"1225","DOI":"10.1097\/00006534-199612000-00016","article-title":"Microbial evaluation: 139 implants removed from symptomatic patients.","volume":"98","author":"Ahn","year":"1996","journal-title":"Plast Reconstr Surg"},{"issue":"5","key":"zoi231411r13","doi-asserted-by":"publisher","first-page":"921","DOI":"10.1097\/PRS.0000000000001682","article-title":"Breast implant\u2013associated infections: the role of the National Surgical Quality Improvement Program and the local microbiome.","volume":"136","author":"Cohen","year":"2015","journal-title":"Plast Reconstr Surg"},{"issue":"4","key":"zoi231411r14","doi-asserted-by":"publisher","first-page":"284","DOI":"10.1097\/00000637-198910000-00003","article-title":"Infection following breast reconstruction.","volume":"23","author":"Armstrong","year":"1989","journal-title":"Ann Plast Surg"},{"key":"zoi231411r15","doi-asserted-by":"publisher","DOI":"10.1097\/PRS.0000000000010869","article-title":"Antibiotic implant irrigation and deep infection: a retrospective study of 1508 patients undergoing breast reconstruction with implants.","author":"Hemmingsen","journal-title":"Plast Reconstr Surg"},{"issue":"3","key":"zoi231411r16","doi-asserted-by":"publisher","first-page":"249","DOI":"10.1016\/j.asj.2005.02.006","article-title":"Late infection following breast augmentation with textured silicone gel\u2013filled implants.","volume":"25","author":"Basile","year":"2005","journal-title":"Aesthet Surg J"},{"issue":"1","key":"zoi231411r17","doi-asserted-by":"publisher","first-page":"111","DOI":"10.1016\/j.idc.2011.09.003","article-title":"Breast implant infections.","volume":"26","author":"Washer","year":"2012","journal-title":"Infect Dis Clin North Am"},{"issue":"1","key":"zoi231411r18","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1002\/jor.v36.1","article-title":"Bacteria antibiotic resistance: new challenges and opportunities for implant-associated orthopedic infections.","volume":"36","author":"Li","year":"2018","journal-title":"J Orthop Res"},{"issue":"6","key":"zoi231411r19","doi-asserted-by":"publisher","first-page":"1596","DOI":"10.1097\/00006534-200105000-00049","article-title":"Optimizing breast-pocket irrigation: the post-Betadine era.","volume":"107","author":"Adams","year":"2001","journal-title":"Plast Reconstr Surg"},{"issue":"6","key":"zoi231411r20","doi-asserted-by":"publisher","first-page":"933e","DOI":"10.1097\/PRS.0000000000005050","article-title":"Modern primary breast augmentation: best recommendations for best results.","volume":"142","author":"Wan","year":"2018","journal-title":"Plast Reconstr Surg"},{"issue":"4","key":"zoi231411r21","doi-asserted-by":"publisher","first-page":"1142","DOI":"10.1097\/01.prs.0000481110.31939.e4","article-title":"Current trends and controversies in breast augmentation.","volume":"137","author":"Hidalgo","year":"2016","journal-title":"Plast Reconstr Surg"},{"issue":"5","key":"zoi231411r22","doi-asserted-by":"publisher","first-page":"1179","DOI":"10.1007\/s00266-018-1166-2","article-title":"Breast pocket irrigation with antibiotic solution at implant insertion: a systematic review and meta-analysis.","volume":"42","author":"Lynch","year":"2018","journal-title":"Aesthetic Plast Surg"},{"issue":"1","key":"zoi231411r23","doi-asserted-by":"publisher","first-page":"66","DOI":"10.1093\/asj\/sjac238","article-title":"Enhancing patient outcomes in aesthetic breast implant procedures using proven antimicrobial breast pocket irrigations: a 20-year follow-up.","volume":"43","author":"Venkataram","year":"2023","journal-title":"Aesthet Surg J"},{"issue":"9596","key":"zoi231411r24","doi-asserted-by":"publisher","first-page":"1453","DOI":"10.1016\/S0140-6736(07)61602-X","article-title":"The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.","volume":"370","author":"von Elm","year":"2007","journal-title":"Lancet"},{"issue":"9","key":"zoi231411r25","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2021-058697","article-title":"Prophylactic treatment of breast implants with a solution of gentamicin, vancomycin and cefazolin antibiotics for women undergoing breast reconstructive surgery: protocol for a randomised, double-blind, placebo-controlled trial (the BREAST-AB trial).","volume":"12","author":"Hemmingsen","year":"2022","journal-title":"BMJ Open"},{"issue":"2","key":"zoi231411r26","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","article-title":"Research electronic data capture (REDCap)\u2014a metadata-driven methodology and workflow process for providing translational research informatics support.","volume":"42","author":"Harris","year":"2009","journal-title":"J Biomed Inform"},{"issue":"11","key":"zoi231411r28","doi-asserted-by":"publisher","first-page":"1987","DOI":"10.1016\/j.ophtha.2005.06.025","article-title":"An ophthalmologist\u2019s guide to understanding antibiotic susceptibility and minimum inhibitory concentration data.","volume":"112","author":"Kowalski","year":"2005","journal-title":"Ophthalmology"},{"issue":"2","key":"zoi231411r29","doi-asserted-by":"publisher","first-page":"459","DOI":"10.1097\/PRS.0000000000009293","article-title":"How to report data on bilateral procedures and other issues with clustered data: the CLUDA Reporting Guidelines.","volume":"150","author":"Hemmingsen","year":"2022","journal-title":"Plast Reconstr Surg"},{"issue":"43","key":"zoi231411r30","doi-asserted-by":"publisher","first-page":"1686","DOI":"10.21105\/joss","article-title":"Welcome to the tidyverse.","volume":"4","author":"Wickham","year":"2019","journal-title":"J Open Source Softw"},{"issue":"12","key":"zoi231411r31","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0146021","article-title":"Dose-response analysis using R.","volume":"10","author":"Ritz","year":"2015","journal-title":"PLoS One"},{"key":"zoi231411r32","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1007\/s10928-015-9432-2","article-title":"Simple, automatic noncompartmental analysis: the PKNCA R package.","volume":"42","author":"Denney","year":"2015","journal-title":"J Pharmacokinet Pharmacodyn"},{"issue":"1","key":"zoi231411r33","doi-asserted-by":"publisher","first-page":"253","DOI":"10.1097\/PRS.0000000000005727","article-title":"Discussion: the questionable role of antibiotic irrigation in breast augmentation.","volume":"144","author":"Adams","year":"2019","journal-title":"Plast Reconstr Surg"},{"issue":"5","key":"zoi231411r34","doi-asserted-by":"publisher","first-page":"1319","DOI":"10.1097\/PRS.0b013e3182a3c105","article-title":"The role of bacterial biofilms in device-associated infection.","volume":"132","author":"Deva","year":"2013","journal-title":"Plast Reconstr Surg"},{"issue":"6","key":"zoi231411r35","doi-asserted-by":"publisher","first-page":"1773","DOI":"10.1097\/PRS.0b013e31818d5899","article-title":"Pharmacokinetics of topical and intravenous cefazolin in patients with clean surgical wounds.","volume":"122","author":"White","year":"2008","journal-title":"Plast Reconstr Surg"},{"key":"zoi231411r36","doi-asserted-by":"publisher","first-page":"S341","DOI":"10.1093\/infdis\/128.Supplement_2.S341","article-title":"Pharmacokinetics of cefazolin compared with four other cephalosporins.","volume":"128","author":"Kirby","year":"1973","journal-title":"J Infect Dis"},{"key":"zoi231411r27","volume-title":"M100 Oerformance Standards for Antimicrobial Susceptibility Testing","author":"Clinical and Laboratory Standards Institute","edition":"33rd ed"},{"key":"zoi231411r1","unstructured":"American Cancer Society. Key statistics for breast cancer. Published 2023. Accessed March 24, 2023. https:\/\/www.cancer.org\/cancer\/breast-cancer\/about\/how-common-is-breast-cancer.html"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2813017\/hemmingsen_2023_oi_231411_1702310630.25859.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,12,19]],"date-time":"2023-12-19T16:01:21Z","timestamp":1703001681000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2813017"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,19]]},"references-count":36,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2023,12,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2023.48414","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12,19]]}}}