Clinical Research Directory

Pseudomonas Aeruginosa Injection Combined With Polyvinylpyrrolidone-Iodine in Immediate Breast Reconstruction Surgery With Implants

Sponsor: Jianyi Li

Summary

Brief Summary This study hypothesizes that in immediate breast reconstruction following tumor resection, the application of inactivated Pseudomonas aeruginosa preparation (PAP) may reduce infection rates by decreasing postoperative drainage output and shortening drainage tube removal time. Additionally, the local aseptic inflammation induced by PAP may promote fibrous capsule formation around the implant, shorten postoperative shaping time, and improve patients' quality of life and satisfaction. To test this hypothesis, the investigators designed a study to evaluate the efficacy of PAP compared with PI/TAB irrigation alone. Primary endpoints include drainage tube removal time and capsular contracture rate (assessed by Baker grade). Secondary endpoints include infection rate, total drainage volume, and postoperative BREAST-Q scores. Different concentrations of PAP will also be evaluated to determine the optimal therapeutic concentration. Detailed Description Postoperative infection rates in breast implant procedures range from 1% to 35%. Infection necessitates antibiotic treatment, may lead to unnecessary reoperations, and contributes to patient dissatisfaction. Inflammation and infection around the implant can promote biofilm formation, leading to capsular contracture (CC) following breast implant surgery. In patients undergoing breast reconstruction after tumor resection, postoperative infection may also delay adjuvant cancer treatment. Consequently, various antimicrobial irrigation solutions are routinely employed in immediate breast reconstruction after cosmetic surgery or tumor resection to reduce infection and CC rates, including 10% povidone-iodine (PI) and triple antibiotic solutions. PI irrigation was first introduced by Burkhardt et al. in the 1980s for cosmetic breast surgery, followed by the development of a broader-spectrum triple antibiotic solution (TAB) by Adams et al. In 2000, the FDA prohibited the use of PI with breast implants due to concerns regarding higher contracture rates and potential degradation of silicone implants. Subsequent research by Adams et al. led to the development of a PI-free irrigation solution (TAB), which demonstrated comparable efficacy, albeit with slightly reduced coverage against Gram-negative bacteria. In August 2017, based on accumulated long-term data, the FDA lifted the restriction on PI use with implants, permitting its application for bacterial/biofilm mitigation and antimicrobial prophylaxis. Subsequent studies comparing the antimicrobial efficacy of PI and TAB have yielded mixed results, and a meta-analysis found no significant difference in CC rates between the two irrigation methods. However, the FDA withdrew bacitracin injections in 2020 due to safety concerns. As a result, standardization of antimicrobial irrigation solutions for implant-based immediate breast reconstruction remains lacking. Notably, immediate reconstruction following tumor resection differs fundamentally from cosmetic surgery. For instance, the 14-point plan for cosmetic breast surgery recommends avoiding drainage tubes, a practice often unfeasible in immediate reconstruction, where two drainage tubes are typically placed for 4-7 days postoperatively. Breast surgeons aim to minimize drainage tube duration owing to the increased risk of surgical site infection (SSI). In immediate reconstruction, capsule formation time is prolonged compared with augmentation surgery, potentially leading to implant displacement and contracture. PAP, derived from an inactivated PA-MSHA strain, has been shown by Long et al. to reduce postoperative drainage and shorten drainage tube removal time. PAP may also promote fibrous capsule formation, thereby reducing infection rates and improving patients' quality of life.

Official title: Pseudomonas Aeruginosa Injection Combined With Polyvinylpyrrolidone-Iodine in Immediate Breast Reconstruction Surgery With Implants：a Randomized Controlled Trial

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