Background: Capsular contracture represents the most frequent complication after implant-based breast reconstruction. An experimental study on mice demonstrated that capsule formation around breast implants is considerably diminished after topical application of mitomycin C. The authors conducted a randomized controlled clinical trial investigating the efficacy of mitomycin C in reducing capsular contracture rates following implant-based breast reconstruction after mastectomy for breast cancer. Methods: The authors randomized all women older than 18 years scheduled for the second stage of an implant-based breast reconstruction after mastectomy for breast cancer at the National Cancer Institute in Milan from October of 2005 to February of 2010 to receive or not receive the topical application of mitomycin C during surgery. The authors assessed capsular contracture, major postoperative complications, and aesthetic outcome. Results: The authors randomized 322 patients to receive mitomycin C or not at the second stage of implant-based breast reconstruction. One hundred sixty-two patients were allocated to the mitomycin C group and 160 patients were allocated to the control group. The relative risk of capsular contracture in the mitomycin C group was 0.92 (95 percent CI, 0.60 to 1.41). Major complications leading to reintervention, oncologic outcomes, and aesthetic outcomes were comparable between the two groups. Conclusions: This is the first trial reporting data about the use of mitomycin C in breast reconstructive surgery in a clinical setting. Mitomycin C seems not to significantly affect capsular contracture rate and severity following implant-based reconstructive breast surgery at the tested doses. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
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