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DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction

Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Capsular Contracture; Dimethyl Sulfoxide

Intervention: Dimethyl Sulfoxide (Drug); Saline 0.9% (Drug)

Phase: Phase 2/Phase 3

Status: Not yet recruiting

Sponsored by: Rabin Medical Center

Official(s) and/or principal investigator(s):
Sagit Meshulam Derazon, MD, Principal Investigator, Affiliation: Rabin Medical Center

Overall contact:
Sagit Meshulam Derazon, MD, Phone: +97239376366, Email: sagitmd@gmail.com

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: reduction of 50% or more in capsular contructure incidence

Secondary outcome:

reduction in maximal capsular thickness (MCT) in sonography evaluation

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

reduction in VAS pain score in treatment group

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

Locations and Contacts

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

Rabin Medical Center, Petach Tikva, Israel; Not yet recruiting
Sagit Meshulam Derazon, MD, Principal Investigator
Additional Information

Starting date: August 2014
Last updated: July 31, 2014

Page last updated: August 23, 2015

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