Breast Capsular Contracture Clinical Trial
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.
| Status | Not yet recruiting |
| Enrollment | 110 |
| Est. completion date | |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rabin Medical Center | Petach Tikva |
| Lead Sponsor | Collaborator |
|---|---|
| Rabin Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | reduction of 50% or more in capsular contructure incidence | 3.5 years | No | |
| Secondary | reduction in maximal capsular thickness (MCT) in sonography evaluation | 3.5 years | No | |
| Secondary | evidence of less inflamation and fibrosis in pathology examination of the capsule | 3.5 years | No | |
| Secondary | reduction in VAS pain score in treatment group | 3.5 years | No |