Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast

Study Overview
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Brief Summary
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Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast

Detailed Description
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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

Official Title
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Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast

Conditions
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Capsular Contracture, Implant

Intervention / Treatment
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* Drug: Dexamethasone
* Device: US


Participation Criteria
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Eligibility Criteria
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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

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: one treatment group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>The treatment group will be injected with dexamethasone instracapsular under US according to our built protocol. | Drug: Dexamethasone<br>* dexamethasone will be injected intracapsular under US<br>Device: US<br>* dexamethasone will be injected intracapsular under US<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reducing maximum capsular thickness (MCT) | measured by ultrasound | 3.5 years | 
| reduce pain | pain assessed with visual analogue score (pain-VAS). | 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