Infection Outcomes in Implant-Based Breast Reconstruction: Five-Year Experience with the GAPS Protocol.

Abstract

Surgical-site infections (SSI) are a major complication of implant-based breast reconstruction (IBBR), with no widely adopted prevention protocol. We evaluated the effectiveness of the 12-step Gloves, Antimicrobial soak, Pocket irrigation, and Sterile field (GAPS) protocol in reducing SSI after IBBR. We performed a quasi-experimental prospective cohort study with historical controls of immediate IBBR at a single academic health system (January 2018-December 2023). The GAPS protocol was implemented in December 2019; follow-up extended 90 days postoperatively. The primary outcome was SSI. Relative risks (RR), absolute risk reduction (ARR), and number needed to treat (NNT) were calculated. Among 915 patients (1,500 breasts), the protocol cohort (604 patients, 994 breasts) had lower SSI rates than controls (311 patients, 506 breasts): 5.7% versus 8.7% (P = .03). The unadjusted relative risk was 0.66 (95% CI, 0.45-0.96). Across single-covariate adjustments (age, prior radiation, smoking, implant plane, seroma, and acellular dermal matrix [ADM]), the protocol remained directionally protective (RR range 0.57-0.76). In fully-adjusted multivariable models, the total effect was RR 0.76 (95% CI 0.50-1.15; P = .195), and the direct effect, adjusting for seroma as a post-exposure mediator, was RR 0.66 (95% CI 0.43-1.01; P = .053). Protocol adherence was approximately 80%, with an ARR of 2.96% and NNT of 34. The GAPS protocol was associated with reduced SSI after IBBR with directionally consistent protective estimates across adjusted models. These findings support structured perioperative infection-prevention protocols to improve reconstructive outcomes and reduce healthcare burden.