infection is a feared complication in implant-based reconstruction Standard of practice: surgical site irrigation of post-mastectomy pocket with antimicrobial solution prior to implant placement Most often, triple antibiotic solution with gentamicin, cefazolin, and bacitracin

Objectives

To characterize effects of the ban on a macroscopic, nationwide level To assess the need for comparable alternatives to bacitracin solution for prevention of surgical site infection

Did the National Ban on Bacitracin Irrigation Affect Infection Rates in Implant-Based Breast Reconstruction? An Analysis of a National Database

Olachi Oleru, MD 1; Arya Akhavan, MD 1; Nargiz Seyidova, MD, MHQS 1; Taylor Ibelli, MS 2; Nikita Roy, MPH 1; Peter J. Taub, MD, MS 1; Peter Henderson, MD, MBA 1 Icahn School of Medicine at Mount SInai, Division of Plastic and Reconstructive Surgery Tel Aviv University

Acknowledgements

Dr. Oleru was supported the by the National Center for Advancing Translational Sciences (NCATS) TL1TR004420 NRSA TL1 Training Core in Transdisciplinary Clinical and Translational Science (CTSA) grant.

 

Many thanks to the Icahn School of Medicine at Mount Sinai Department of Surgery and Division of Plastic and Reconstructive Surgery

Results

Related literature Adams WP Jr, Conner WC, Barton FE Jr, Rohrich RJ. Optimizing breast-pocket irrigation: the post-betadine era. Plast Reconstr Surg. 2001;107(6):1596-1601.https://dig.pharmacy.uic.edu/faqs/2021-2/june-2021-faqs/why-has-bacitracin-for-injection-been-withdrawn-and-are-alternative-irrigation-solutions-recommended-to-prevent-pocket-infection-during-implantation-of-cardiovascular-implantable-electronic-devices/ Nguyen L, Afshari A, Green J, et al. Post-Mastectomy Surgical Pocket Irrigation With Triple Antibiotic Solution vs Chlorhexidine Gluconate: A Randomized Controlled Trial Assessing Surgical Site Infections in Immediate Tissue Expander Breast Reconstruction. Aesthet Surg J. 2021;41(11):NP1521-NP1528. Adams WP Jr, Rios JL, Smith SJ. Enhancing patient outcomes in aesthetic and reconstructive breast surgery using triple antibiotic breast irrigation: six-year prospective clinical study. Plast Reconstr Surg. 2006;118(7 Suppl):46S-52S. US Food and Drug Administration Antimicrobial Drugs Advisory Committee. Website. FDA Brief Doc Bacitracin Intramuscular Inject. Published online April 2019. https://www.fda.gov/media/123641/download Rodriguez R. Why has bacitracin for injection been withdrawn, and are alternative irrigation solutions recommended to prevent pocket infection during implantation of cardiovascular implantable electronic devices? Univ Ill Chic Montly FAQs. 2021;June FAQs. https://dig.pharmacy.uic.edu/faqs/2021-2/june-2021-faqs/why-has-bacitracin-for-injection-been-withdrawn-and-are-alternative-irrigation-solutions-recommended-to-prevent-pocket-infection-during-implantation-of-cardiovascular-implantable-electronic-devices/

Conclusions

In patients who underwent implant-based reconstruction, there were higher odds of developing wound infection, all complications and reoperations after the injectable bacitracin ban.

Database

Primary Outcomes

ACS National Surgical Quality Improvement Program

Implant-based reconstruction CPT codes

Pre-Ban

Post-Ban

2012-2020

19340 19342 19357

2012-2019

2020

More study into suitable alternatives to injectable bacitracin for surgical site antimicrobial irrigation are warranted, such as chlorhexidine and betadine.

Methodology

Bacitracin acts on gram positives, useful for skin flora like staph and strep Empyema/pneumonia in infants was the only FDA approved indication for injectable bacitracin FDA initiated a formal ban on injectable bacitracin in January 2020 given risks of nephrotoxicity and anaphyaxis

Postoperative infection within 30 days

Multivariate regression analysis of postoperative complications

Chi square analysis (after case-control matching) of postoperative complications, all p<0.05

These charts represents demographics and comorbidities after case-control matching. After matching, there were no differences in demographics. Only hypertension and bleeding disorders had significant differences after matching.

*Race refers to White race. ASA Class refers to ASA Class 2

 

Peripros