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

Clalit Health Services

Status: Unknown

Conditions: Capsular Contracture, Implant

Treatments: Drug: Dexamethasone; Device: US

Study type: Interventional

Funder types: Other

Identifiers

NCT03171974

0213-17-RMC

Details and patient eligibility

About

Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast

Full 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

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

treatment group

Experimental group

Description:

The treatment group will be injected with dexamethasone instracapsular under US according to our built protocol.

Treatment:

Drug: Dexamethasone

Device: US