NCT06785610

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Apr 2025Aug 2026

First Submitted

Initial submission to the registry

January 15, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 8, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

January 5, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 15, 2025

Last Update Submit

January 2, 2026

Conditions

Capsular Contracture Associated With Implant

Keywords

Capsular ContractureMastectomy reconstructionDefinitive silicone implant

Outcome Measures

Primary Outcomes (1)

  • Capsular contracture rate

    Number of capsular contracture at 1-year follow-up

    1 year

Secondary Outcomes (2)

  • Capsular contracture rate compared to historical data

    1 year

  • Patient satisfaction

    1 year

Study Arms (1)

Capsulase® supplementation

EXPERIMENTAL

Capsulase® supplementation in the postoperative period

Dietary Supplement: Capsulase®

Interventions

Capsulase®DIETARY_SUPPLEMENT

Capsulase® supplement daily administration after surgery

Capsulase® supplementation

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Immediate post mastectomy reconstruction with definitive silicone implant (microtextured prosthesis) (both therapeutic and risk reducing mastectomies)
  • Informed consent
  • Unilateral and bilateral mastectomies

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

Study Officials

  • Francesca De Lorenzi, MD

    European Istitute of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single-center, single-arm prospective study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 21, 2025

Study Start

April 8, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 5, 2026

Record last verified: 2026-01

Locations

IT(1)