Clinical trial NCT06785610: Prevention of Capsular Contracture in Postmastectomy Patients Undergoing Implant-based Reconstructions
Official title: A Single-center, Single-arm Prospective Study to Evaluate Capsulase for Prevention of Capsular Contracture in Postmastectomy Patients Undergoing Implant-based Reconstructions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Capsular Contracture Associated With Implant
Keywords: Capsular Contracture
Mastectomy reconstruction
Definitive silicone implant
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-center, single-arm prospective study
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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 outcomes:
measure: Capsular contracture rate
timeFrame: 1 year
Secondary outcomes:
measure: Capsular contracture rate compared to historical data
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Istitute of Oncology
name: Francesca De Lorenzi, MD
role: PRINCIPAL_INVESTIGATOR
References: