DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction
NCT ID: NCT02206477
Last Updated: 2014-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
110 participants
INTERVENTIONAL
2014-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Dimethyl Sulfoxide
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.
Saline 0.9%
Interventions
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Dimethyl Sulfoxide
Saline 0.9%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Sagit Meshulam-Derazon
MD; Head of breast reconstruction unit
Principal Investigators
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Sagit Meshulam Derazon, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Rabin Medical Center
Petah Tikva, , Israel
Countries
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Central Contacts
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Other Identifiers
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0005-13-RMC
Identifier Type: -
Identifier Source: org_study_id
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