search
Back to results

DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction

Primary Purpose

Breast Capsular Contracture, Dimethyl Sulfoxide

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Dimethyl Sulfoxide
Saline 0.9%
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Capsular Contracture focused on measuring breast capsular contructure, dimethyl sulfoxide, radiotherapy, breast reconstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Rabin Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DMSO treatment group

the control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

reduction of 50% or more in capsular contructure incidence

Secondary Outcome Measures

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

Full Information

First Posted
July 31, 2014
Last Updated
July 31, 2014
Sponsor
Rabin Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02206477
Brief Title
DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Capsular Contracture, Dimethyl Sulfoxide
Keywords
breast capsular contructure, dimethyl sulfoxide, radiotherapy, breast reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DMSO treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
the control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dimethyl Sulfoxide
Other Intervention Name(s)
DMSO
Intervention Type
Drug
Intervention Name(s)
Saline 0.9%
Other Intervention Name(s)
normal saline
Primary Outcome Measure Information:
Title
reduction of 50% or more in capsular contructure incidence
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
reduction in maximal capsular thickness (MCT) in sonography evaluation
Time Frame
3.5 years
Title
evidence of less inflamation and fibrosis in pathology examination of the capsule
Time Frame
3.5 years
Title
reduction in VAS pain score in treatment group
Time Frame
3.5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sagit Meshulam Derazon, MD
Phone
+97239376366
Email
sagitmd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sagit Meshulam Derazon, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tikva
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sagit Meshulam Derazon, MD

12. IPD Sharing Statement

Learn more about this trial

DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction

We'll reach out to this number within 24 hrs