Capsular Contracture Associated With Implant
Conditions
Keywords
Capsular Contracture, Mastectomy reconstruction, Definitive silicone implant
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.
Interventions
DIETARY_SUPPLEMENTCapsulase®
Capsulase® supplement daily administration after surgery
Sponsors
European Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single-center, single-arm prospective study
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Capsular contracture rate | 1 year | Number of capsular contracture at 1-year follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Capsular contracture rate compared to historical data | 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 |
| Patient satisfaction | 1 year | Completion of BREAST-Q questionnaire (higher answers to each item reflect a better outcome) |
Countries
Italy
Outcome results
None listed