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Is Extended Postoperative Antibiotics For Tissue Expander Based Immediate Breast Reconstruction Necessary? Preliminary Results of a Prospective Randomized Clinical Trial
Brett T. Phillips, MD1, Eric D. Wang, BS2, Heather L. Lander, BS2, Alexandra J. Rodman, BA2, Alexander B. Dagum, MD1, Jason C. Ganz, MD1, Sami U. Khan, MD1, Duc T. Bui, MD1.
1Stony Brook University Medical Center, Stony Brook, NY, USA, 2Stony Brook University School of Medicine, Stony Brook, NY, USA.
BACKGROUND: Antibiotics and closed suction drains are used routinely in postoperative tissue expander based immediate breast reconstruction (TE-IBR). Prophylactic postoperative antibiotics are frequently prescribed due to the presence of implants and drains, which may serve as a channel for outside contaminants. Current general guidelines for surgical antibiotic prophylaxis are recommended for only 24 hours. There are no prospective randomized controlled trials suggesting that extended antibiotic prophylaxis is beneficial to our patients. We report the early results of a prospective randomized controlled trial designed to assess the difference in surgical site infection (SSI) between 24 hours and an extended course of antibiotics. Our null hypothesis is that there is no difference in SSI between the study cohorts.
METHODS: We designed a prospective randomized controlled trial, in which TE-IBR patients are randomized to receiving 24-hours of perioperative antibiotics only or to receiving 24-hours of perioperative antibiotics with continued postoperative oral antibiotics until all closed suction drains are removed. Our primary outcome is SSI as defined by the CDC. Operative and postoperative protocols are standardized for all patients. Intravenous Cefazolin is given during the first 24 hours followed by oral Cephalexin postoperatively. Penicillin allergic patients are given IV and/or oral Clindamycin. Patients are followed in clinic to document outcomes and compliance. Endpoints are one year after first-stage reconstruction, second-stage implant exchange, SSI, implant loss, or re-operation due to necrosis or hematoma/seroma formation. Our study was designed for 90% power in establishing non-inferiority at +/- 10% difference in SSI between the study cohorts.
RESULTS: To date, we have completed 29 TE-IBR patients (43 breasts), with calculated necessary sample size of 112. 13 patients were randomized to the extended antibiotic group, while 16 patients were in the 24-hour antibiotic group. The patient’s average age was 47 (range: 28-70), with average follow-up time of 2.8 months (range: 0.2 - 5.9). Both groups were similar in regards to demographics and operative characteristics. There were 3 patients in the extended antibiotic cohort who presented with SSI, all of whom were treated with IV antibiotics and 2 subsequently underwent TE Removal (23.1% Infection, 15.4% Implant loss due to infection). There were 2 patients in the 24-hour group who developed SSI, both were treated with oral antibiotics and none required TE removal (12.5% Infection, 0% Implant loss). There was no statistical difference between SSI and Implant loss due to infection in our cohorts (p = 0.6322, p = 0.1921, respectively). Overall surgical complication rates which include infection, necrosis, dehiscence, hematoma and seroma formation were 53.8% (7 of 13 patients) and 31.3% (5 of 16 patients) for the extended antibiotic group and the 24-hour group, respectively (p = 0.2742).
CONCLUSIONS: Preliminary results suggest that 24-hours of antibiotics is not inferior to extended oral antibiotics with regards to the primary outcome of SSI in TE-IBR patients. Extended antibiotic administration can be associated with complications including systemic side effects, super-infection, and development of resistant organisms. Further data and multicenter trials will demonstrate which antibiotic protocol provides superior postoperative care to TE-IBR patients.
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