DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction

NCT02206477 | Unknown Phase 2 DMC

• 1 other identifier: 0005-13-RMC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Capsular Contracture; Dimethyl Sulfoxide

Keywords

breast capsular contructure; dimethyl sulfoxide; radiotherapy; breast reconstruction

Outcome Measures

Primary Outcomes (1)

• reduction of 50% or more in capsular contructure incidence

  3.5 years

Secondary Outcomes (3)

• reduction in maximal capsular thickness (MCT) in sonography evaluation

  3.5 years

• evidence of less inflamation and fibrosis in pathology examination of the capsule

  3.5 years

• reduction in VAS pain score in treatment group

  3.5 years

Study Arms (2)

DMSO treatment group

EXPERIMENTAL

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

the control group

PLACEBO COMPARATOR

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%

Interventions

Dimethyl Sulfoxide DRUG

Also known as: DMSO

DMSO treatment group

Saline 0.9% DRUG

Also known as: normal saline

the control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Interventions

Dimethyl Sulfoxide; Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Sulfoxides; Sulfur Compounds; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sagit Meshulam Derazon, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sagit Meshulam Derazon, MD

CONTACT

+97239376366; sagitmd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; Head of breast reconstruction unit

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 1, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2017
• Last Updated: August 1, 2014

Record last verified: 2014-07

Locations

IL (1)