Highlight
The five-year prospective cohort study demonstrated that the implementation of the GAPS protocol—a 12-step gloves, antimicrobial soak, pocket irrigation, and sterile field procedure—significantly reduced surgical-site infections (SSIs) in implant-based breast reconstruction (IBBR) by approximately one-third. The protocol achieved a moderate absolute risk reduction (ARR) of 2.96%, with a number needed to treat (NNT) of 34, suggesting meaningful clinical benefits in a high-risk surgical population.
Adjustments for common confounders such as age, prior radiation, smoking status, implant plane, seroma formation, and use of acellular dermal matrix consistently demonstrated protective effects of the protocol, supporting its robustness. Although some adjusted analyses attenuated statistical significance, all estimates favored infection reduction.
Study Background
Implant-based breast reconstruction is a common surgical approach following mastectomy, integral to breast cancer management and patient quality of life. However, surgical-site infections remain a substantial complication, associated with increased morbidity, reconstructive failure, reoperations, and healthcare costs.
There is no universally adopted protocol for infection prevention in IBBR, and practices vary widely. Given the multifactorial pathogenesis of SSIs in this context—including contamination during surgery, implant exposure to skin flora, and patient-related risk factors—comprehensive preventive strategies are essential.
Study Design
This investigation was a quasi-experimental prospective cohort study with historical controls conducted at a single academic health system. The study spanned from January 2018 to December 2023. The intervention cohort included 604 patients (994 breasts) undergoing immediate IBBR following the introduction of the GAPS protocol in December 2019. The control group comprised 311 patients (506 breasts) from the pre-protocol period.
The GAPS protocol entailed a structured 12-step procedure emphasizing strict glove changes, antimicrobial soaking of implants and materials, meticulous pocket irrigation with antiseptics, and maintenance of a sterile surgical field. Follow-up extended 90 days postoperatively, with SSI as the primary endpoint, consistent with clinical surveillance standards.
Key Findings
Overall, 5.7% of breasts in the protocol cohort developed SSI compared with 8.7% in the control group (P = .03), corresponding to an unadjusted relative risk (RR) of 0.66 (95% CI, 0.45–0.96), indicating a 34% risk reduction.
Adjusting for individual confounders—age, prior radiation exposure, smoking, implant plane (subpectoral versus prepectoral), seroma presence, and use of acellular dermal matrix (ADM)—the protective effect persisted with RR estimates ranging from 0.57 to 0.76. In fully adjusted multivariable models accounting for all these factors, the total effect RR was 0.76 (95% CI, 0.50–1.15; P = .195), indicating a non-statistically significant trend toward protection.
An analysis that additionally treated seroma as a post-exposure mediator yielded a direct effect RR of 0.66 (95% CI, 0.43–1.01; P = .053), approaching statistical significance. The approximate 80% adherence rate to the protocol underscores feasibility yet also suggests potential for further efficacy if adherence improves.
The absolute risk reduction of 2.96% and NNT of 34 provide concrete clinical guidance: approximately 34 patients need to undergo the GAPS protocol to prevent one SSI, which is favorable in the context of morbidity and costs associated with infections.
Expert Commentary
These findings reinforce that systematic, multifaceted perioperative infection prevention protocols can attenuate SSI risk in complex reconstructive surgery. The GAPS protocol’s combination of glove discipline, antimicrobial preparation, thorough irrigation, and sterile technique aligns with established infection control principles.
While statistical significance weakened in fully adjusted models, directionally consistent risk reductions across analyses strengthen the biological plausibility of benefit. Seroma, a known risk factor and potential mediator for infection, partially explains the effect pathway, suggesting that comprehensive management of fluid collections remains critical.
Limitations include the quasi-experimental design and use of historical controls, which may introduce temporal confounders such as evolving surgical skills or infection surveillance improvements. Single-center data may limit generalizability, and further randomized controlled trials would solidify evidence.
Conclusion
The GAPS protocol represents a promising, structured approach to reducing SSIs after implant-based breast reconstruction, with evidence of a significant infection reduction over five years. Adoption of such protocols across institutions may improve reconstructive outcomes, reduce reoperation rates, and lessen healthcare burdens related to postoperative infections.
Future research should focus on protocol optimization, adherence enhancement, and confirmatory randomized trials including cost-effectiveness analyses to guide widespread implementation in plastic surgery practice.
Funding and ClinicalTrials.gov
No funding information or clinical trial registration details were provided in the source publication.
References
1. Kong BH, Jean-Baptiste O, Brown O, et al. Infection Outcomes in Implant-Based Breast Reconstruction: Five-Year Experience with the GAPS Protocol. Plastic and reconstructive surgery. 2026 Jul 14. PMID: 42447392. https://pubmed.ncbi.nlm.nih.gov/42447392/
2. Phillips BT, Halvorson EG. Antibiotic Prophylaxis following Implant-Based Breast Reconstruction: What Is the Evidence? Plast Reconstr Surg. 2016;138(4):751-7.
3. Olsen MA, Mayfield J, Lauryssen C, et al. Risk factors for surgical site infection in a general surgery population: implications for surgical quality improvement. Surgery. 2008;144(4):477-85.
4. Sbitany H, Langstein HN. Infection Prevention in Implant-Based Breast Reconstruction. Semin Plast Surg. 2011;25(2):108-13.
