DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction

Study Overview
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Brief Summary
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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
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Breast Capsular Contracture, Dimethyl Sulfoxide

Intervention / Treatment
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* Drug: Dimethyl Sulfoxide
* Drug: Saline 0.9%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMSO treatment group<br>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<br> <br> * Other names: DMSO;|
| Placebo Comparator: the control group<br>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%<br> <br> * Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast capsular contructure, dimethyl sulfoxide, radiotherapy, breast reconstruction