Active — Not RecruitingNot Applicable

Prevention of Capsular Contracture in Postmastectomy Patients Undergoing Implant-based Reconstructions

Italy100 participantsStarted 2025-04-08

Plain-language summary

The study plans to evaluate capsular contracture at 1-year follow-up in postmastectomy patients receiving immediate implant-based reconstruction and Capsulase® supplementation in the postoperative period. These data are compared with historical data of capsular contracture in patients not receiving any food supplementation postoperatively. Aim of the study is to collect preliminary data to support Capsulase® supplementation in the postoperative period to prevent capsular contracture.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Immediate post mastectomy reconstruction with definitive silicone implant (microtextured prosthesis) (both therapeutic and risk reducing mastectomies) * Informed consent * Unilateral and bilateral mastectomies Exclusion Criteria: * Hypersensitivity to Capsulase® * Pregnant women * Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality) * Patients with previous breast implants * Revisional surgery for capsular contracture * Use of micro polyurethane foam-coated implants * Mesh and matrix-assisted reconstructions * Reconstruction of previous irradiated breasts

What they're measuring

Capsular contracture rate

Timeframe: 1 year

Trial details

NCT IDNCT06785610

SponsorEuropean Institute of Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

View on ClinicalTrials.gov More Capsular Contracture Associated With Implant trials