Are Prophylactic Postoperative Antibiotics Necessary for Immediate Breast Reconstruction? Results of a Prospective Randomized Clinical Trial.

BACKGROUND: Closed-suction drains, implants, and acellular dermal matrix (ADM) are routinely used in tissue expander-based immediate breast reconstruction (TE-IBR). Each of these factors is thought to increase the potential for surgical site infection (SSI). Although CDC guidelines recommend only 24 hours of antibiotic prophylaxis after TE-IBR, current clinical practices vary significantly. This study evaluated the difference in SSI between 2 different prophylactic antibiotic durations. STUDY
DESIGN: A noninferiority randomized controlled trial was designed in which TE-IBR patients received antibiotics either 24 hours postoperatively or until drain removal. The primary outcome was SSI, as defined by CDC criteria. Operative and postoperative protocols were standardized. Secondary endpoints included clinical outcomes up to 1 year and all implant loss, or reoperation.
RESULTS: There were 112 TE-IBR patients (180 breasts) using ADM who were randomized into 2 study arms, with 62 patients in the 24-hour group and 50 in the extended group. Surgical site infection was diagnosed in 12 patients in the 24-hour group and 11 in the extended group (19.4% vs 22.0%, p = 0.82). The extended group had 7 patients who required IV antibiotics and an overall implant loss in 7 patients (14.0%). The 24-hour group had 4 patients who required IV antibiotics, with 3 requiring removal (4.8%). Patients with diabetes, postoperative seroma, or wound dehiscence were all more likely to develop SSI (p < 0.02).
CONCLUSIONS: In a randomized controlled noninferiority trial, 24 hours of antibiotics is equivalent to extended oral antibiotics for SSI in TE-IBR patients. Additional multicenter trials will further assess this important aspect of TE-IBR postoperative care.

RCT Entities:   Population Interventions Outcomes