NCT02206477

DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Capsular contraction is the one of the most common complications of both esthetic and reconstructive breast surgery, with high incidence after radiotherapy. The mechanism of the contraction is unclear, but is believed to be similar to the formation of hypertrophic scarring. Dimethyl sulfoxide (DMSO) has demonstrated its use as an anti-inflammatory, anti-proliferative, and antibacterial agent. The aim of this study is to test the effect of DMSO on the incidence and severity if capsular contracture after breast alloplastic reconstruction in irradiated patients. We conduct a prospective randomized-control single-surgeon study in the tertiary academic Rabin Medical Center. 110 female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction will be included. They will be divided into two groups: the DMSO treatment group, which will be treated according to our protocol, and the control group, that will be treated with the same protocol but with 0.9% saline instead. Several measures will be taken, including: capsular contracture grading by two plastic surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography evaluation, and pathology examination of the capsule (biopsy will be taken during the second stage operation). Rates and grades of capsular contracture evident clinically, radiologically and pathologically, will be evaluated and compared.

Conditions

• Breast Capsular Contracture
• Dimethyl Sulfoxide

Interventions

Type	Name	Description
DRUG	Dimethyl Sulfoxide
DRUG	Saline 0.9%

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-12-01
• First posted: 2014-08-01
• Last updated: 2014-08-01

Locations

1 site across 1 country: Israel