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

European Institute of Oncology

Status: Active, not recruiting

Conditions: Capsular Contracture Associated With Implant

Treatments: Dietary Supplement: Capsulase®

Study type: Interventional

Funder types: Other

Identifiers

NCT06785610

L2-269 (Other Identifier)

UID 4634

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Capsulase® supplementation

Experimental group

Description:

Capsulase® supplementation in the postoperative period

Treatment:

Dietary Supplement: Capsulase®