DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction

July 31, 2014 updated by: Sagit Meshulam-Derazon, Rabin Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sagit Meshulam Derazon, MD
  • Phone Number: +97239376366
  • Email: sagitmd@gmail.com

Study Locations

  • Israel
      • Petach Tikva, Israel
        • Rabin Medical Center
        • Principal Investigator:
          • Sagit Meshulam Derazon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DMSO treatment group
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.
Drug: Dimethyl Sulfoxide
Other Names:
  • DMSO
PLACEBO_COMPARATOR: the control group
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.
Drug: Saline 0.9%
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reduction of 50% or more in capsular contructure incidence
Time Frame: 3.5 years
3.5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Sagit Meshulam Derazon, MD, Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

July 31, 2014

First Posted (ESTIMATE)

August 1, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2014

Last Update Submitted That Met QC Criteria

July 31, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0005-13-RMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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