A randomized controlled trial: application of inactivated Pseudomonas aeruginosa preparation in nipple-sparing mastectomy with immediate prosthetic reconstruction for breast cancer.

BACKGROUND: Breast cancer is one of the most commonly diagnosed malignancies worldwide. For patients undergoing nipple-sparing mastectomy with immediate prosthetic reconstruction (NSM-IPR), optimizing postoperative recovery and reducing complications are critical. Prolonged postoperative drainage is a common issue that increases infection risk and prolongs hospital stay. This study aimed to evaluate the effect of an inactivated Pseudomonas aeruginosa preparation (PAP) on postoperative drainage and cosmetic outcomes in this patient population. METHODS: This was a single-center, prospective, four-arm parallel-group randomized controlled trial. A total of 100 patients were randomly assigned in a 1:1:1:1 ratio to receive either low-, medium-, or high-concentration inactivated PAP immersion, or povidone-iodine alone (control). Outcome assessors were blinded. Therapeutic efficacy was assessed, including total drainage volume, drainage duration, complications, and cosmetic outcomes at 3 months postoperatively. RESULTS: Total drainage volume was significantly lower in all PAP groups compared with the control group (low-concentration: 578.4±39.34 mL, medium-concentration: 477.8±35.53 mL, high-concentration: 444.8±34.26 mL vs. control: 733.0±99.43 mL; all P<0.001). Drainage duration was also significantly shorter (low: 13.4±1.98 d, medium: 10.76±2.17 d, high: 10.76±1.88 d vs. control: 15.92±2.58 d; all P<0.001). CONCLUSIONS: The combination of inactivated PAP and povidone-iodine reduces postoperative drainage volume, shortens drainage time, and may improve cosmetic outcomes in patients undergoing NSM-IPR. TRIAL REGISTRATION: ClinicalTrials.gov NCT07460297.