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

January 2, 2026 updated by: European Institute of Oncology

A Single-center, Single-arm Prospective Study to Evaluate Capsulase for Prevention of Capsular Contracture in Postmastectomy Patients Undergoing Implant-based Reconstructions

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Capsular contracture is one of the most common complications of breast implant use, in both reconstructive and aesthetic setting. Research on capsular contracture has focused on reducing bacterial contamination of implant surfaces through antibiotic and antiseptic solutions and, more recently, on the pharmacological control of the inflammation process around the implant. The foreign body reaction is responsible for capsular contracture.

Several experimental studies have demonstrated that it is possible to pharmacologically control the inflammation process around implants reducing the profibrotic substances included in the inflammation pathway.

Among diet supplements there are several substances that have been studied for their anti-inflammatory properties, in particular omega-3 fatty acids and boswellic acids.

Capsulase® is a diet supplement and consists of Boswellia serrata phospholipid INDENA®, palmitoylethanolamide (PEA), quercetin phytosome INDENA®, bromelain 2500 Gelatin Dissolving Units/gram (GDU/g) and vitamin E acetate. Its efficacy and safety in women with contracted breast implants have been evaluated both in the reconstructive and aesthetic setting. Although preliminary results are satisfactory, however the series include a small sample of women.

Aim of this study is to collect preliminary data to support Capsulase® supplementation in the postoperative period to prevent capsular contracture, comparing capsular contracture in postmastectomy patients receiving immediate implant-based reconstruction and Capsulase® supplementation in the postoperative period with historical data of capsular contracture in patients not receiving any food supplementation postoperatively.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20141
        • European Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capsulase® supplementation
Capsulase® supplementation in the postoperative period
Dietary supplement: Capsulase®
Capsulase® supplement daily administration after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Capsular contracture rate
Time Frame: 1 year
Number of capsular contracture at 1-year follow-up
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Capsular contracture rate compared to historical data
Time Frame: 1 year
Capsular contracture rate at 1-year in patients receiving Capsulase® supplementation compared with capsular contracture rate in the historical control arm of patients not receiving any supplementation
1 year
Patient satisfaction
Time Frame: 1 year
Completion of BREAST-Q questionnaire (higher answers to each item reflect a better outcome)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Francesca De Lorenzi, MD, European Istitute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 21, 2025

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UID 4634
  • L2-269 (Other Identifier: Comitato Etico Territoriale Lombardia 2)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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