NCT06785610

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Capsular Contracture Associated With Implant

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Capsulase®	Capsulase® supplement daily administration after surgery

Timeline

• Start date: 2025-04-08
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-01-21
• Last updated: 2026-01-05

Locations

1 site across 1 country: Italy