Randomized Controlled Trial to Assess Negative Pressure Wound Therapy versus Standard-of-care Dressings in Breast Surgery: A Pilot Study.

Background: Standard breast reduction dressings such as Prineo are used to cover surgical wounds, in combination with a binder or support bra. The Prevena Restor BellaForm is a negative pressure wound therapy dressing that covers the entirety of the breast mound and is purported to provide further support and reduce swelling. The aim of this study was to compare the Restor to standard-of-care dressings. Methods: The study was a randomized control trial of women undergoing bilateral breast reduction with one breast being dressed with the Prevena Restor BellaForm dressing and the other having standard of care (Prineo). Outcomes measured were drain outputs, postoperative length of stay, quality of scarring, patient preference for dressings, and adverse events. Follow-up was at 1, 2-6, and 26 weeks. Results: The results show a reduction in postoperative days 1 and 2 average drain output on the Restor side compared with standard dressings. Patient-reported outcome measures showed less bruising. There was no difference in postoperative length of stay and no difference in appearance of scars at the 26-week follow-up period. One patient required removal of the dressing due to irritation and one patient required assistance with resealing of the vacuum. Conclusions: We have shown benefits to drain output and comfort using close incisional negative pressure therapy in breast reduction mammaplasty. We plan to continue to investigate close incisional negative pressure therapy in larger comparative trials for other breast procedures including implant-based reconstruction, where a reduction in drain output could be of great benefit to both healing and reduction of infection risk.

Preventing Bacterial Contamination of Breast Implants Using Infection Mitigation Techniques: An In Vitro Study.

BACKGROUND: Bacterial contamination of implants has been linked to biofilm formation and subsequent infection, capsular contracture, and breast implant-associated anaplastic large cell lymphoma. Reducing contamination during implant insertion should therefore reduce biofilm formation disease sequelae. OBJECTIVES: The aim of this study was to compare levels of contamination between preventative techniques. METHODS: A model to simulate the passage of implants through a skin incision was designed that utilized a sterile textured polyvinyl plastic sheet contaminated with Staphylococcus epidermidis. In the first stage of the polyvinyl contamination model, implants were subject to infection-mitigation techniques and passed through the incision, then placed onto horse blood agar plates and incubated for 24 hours. In the second stage of the study the same contamination was applied to human abdominal wall specimens. A 5 cm incision was made through skin and fat, then implants were passed through and levels of contamination were measured as described. RESULTS: Smooth implants grew a mean of 95 colony-forming units (CFUs; approximately 1 CFU/cm2) and textured implants grew 86 CFUs (also approximately 1 CFU/cm2). CFU counts were analyzed by the Mann-Whitney U-test which showed no significant difference between implant types (P < .05); independent-sample t-tests showed a significant difference. The dependent-variable techniques were then compared as groups by one-way analysis of variance, which also showed a significant reduction compared with the control group (P < .01). CONCLUSIONS: This in vitro study has shown the effectiveness of antiseptic rinse and skin/implant barrier techniques for reducing bacterial contamination of breast implants at the time of insertion.