Capsular Contracture, Implant
Conditions
Keywords
breast capsular contructure
Brief summary
Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast
Detailed description
The aim of this study is to evaluate ultrasound (US)-guided treatment of capsular contracture (CC) in patients with reconstructed/ augmented breast. Capsular contraction is the one of the most common complications of both esthetic and reconstructive breast surgery with an incidence of 0.5-30% and 1-38%, respectively. In irradiated patients the incidence is higher, in the range of 30-67%. It appears most commonly in the first year but in some patients, belated capsular contracture has been noticed. The more severe forms of contraction, Baker grades 3 and 4 with a firm often deformed and painful breast, have been shown to recur as often as 67% after capsulotomy steroid injection has been demonstrated to be effective for the treatment of this condition. 20-30 female with grade III\\IV CC will be included. Patients will be treated with peri-implant US-guided injection of Dexamethasone The purpose of our study is to use a longer acting steroid (Dexamethasone) injected intra capsular with US-guide. By that getting a better effect on the level of fibrosis. This Clinical study will be conducted in the tertiary academic Rabin Medical Center. 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
Interventions
DRUGDexamethasone
dexamethasone will be injected intracapsular under US
DEVICEUS
dexamethasone will be injected intracapsular under US
Sponsors
Rabin Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
one treatment group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• female patient with grade 3-4 capsular contraction after alloplastic breast reconstruction\\ augmentation
Exclusion criteria
* intake of steroids, anti-inflammatory, anti-coagulate or immunomodulatory medications on a regular basis * Patients with skin atrophy of the breast
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reducing maximum capsular thickness (MCT) | 3.5 years | measured by ultrasound |
| reduce pain | 3.5 years | pain assessed with visual analogue score (pain-VAS). |
Countries
Israel
Contacts
Primary ContactMuhammad Mansour, MD
Backup Contactomri dominsky, MD
Outcome results
None listed