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Clinical Trials in Italy / NCT06785610
Active, not recruiting Not applicable

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

NCT06785610 · tracked via the Priya Life Science Italy tracker
Sponsor
European Institute of Oncology
Phase
Not applicable
Started
2025-04-08
Last updated
2026-01-05

Condition(s) studied

Capsular Contracture Associated With Implant

Investigational drug(s) / intervention(s)

Capsulase®

Capsulase®: Capsulase® supplement daily administration after surgery

Study 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.

Eligibility

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Capsular contracture rate — 1 year
    Number of capsular contracture at 1-year follow-up

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06785610 on ClinicalTrials.gov ↗ ← All trials in Italy