DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction

Phase 2

• Conditions: Breast Capsular Contracture; Dimethyl Sulfoxide
• Interventions: Drug: Saline 0.9%; Drug: Dimethyl Sulfoxide

• Registration Number: NCT02206477
• Lead Sponsor: Rabin Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-07
• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-07-31
• Last Update Submitted: 2014-07-31
• Study Start: 2014-08
• Study First Posted: 2014-08-01
• Last Update Posted: 2014-08-01
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction

Exclusion Criteria

• autologous reconstruction
• single-stage alloplastic reconstruction
• intake of steroids, anti-inflammatory, anti-coagulate or immunomodulatory medications on a regular basis
• low compliance to home treatment or follow-ups.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the control group	Saline 0.9%	The control group will be treated with the same post-operative protocol, but with 0.9% saline instead of DMSO. On the seventh post-operative day, the patient will be guided to set 10 cc 0.9% saline soaked gauze compresses on the breast, twice a day for 20 minutes, for the term of 6 weeks. This treatment will be holed for 24 hours on tissue expander inflation dates. A repeated course of compresses will be taken after adjuvant radiotherapy, starting 24 hours after the last therapy.
DMSO treatment group	Dimethyl Sulfoxide	The treatment group will be exposed to DMSO according to our built protocol. On the seventh post-operative day, the patient will be guided to set 10 cc of DMSO soaked gauze compresses on the breast, twice a day for 20 minutes, for the term of 6 weeks. This treatment will be holed for 24 hours on tissue expander inflation dates. A repeated course of compresses will be taken after adjuvant radiotherapy, starting 24 hours after the last therapy.

Primary Outcome Measures

Name	Time	Method
reduction of 50% or more in capsular contructure incidence	3.5 years

Secondary Outcome Measures

Name	Time	Method
reduction in VAS pain score in treatment group	3.5 years
evidence of less inflamation and fibrosis in pathology examination of the capsule	3.5 years
reduction in maximal capsular thickness (MCT) in sonography evaluation	3.5 years

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel