Breast Capsular Contracture, Dimethyl Sulfoxide
Conditions
Keywords
breast capsular contructure, dimethyl sulfoxide, radiotherapy, breast reconstruction
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.
Interventions
DRUGSaline 0.9%
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction of 50% or more in capsular contructure incidence | 3.5 years |
Secondary
| Measure | 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 |
Countries
Israel
Contacts
Primary ContactSagit Meshulam Derazon, MD
Outcome results
None listed