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DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction

NCT02206477 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2014-08-01

No results posted yet for this study

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

DRUG

Dimethyl Sulfoxide

DRUG

Saline 0.9%

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Sagit Meshulam Derazon, MD · Rabin Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02206477 on ClinicalTrials.gov