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

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

Sponsors

Lead Sponsor: Rabin Medical Center

Source Rabin Medical Center
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

Overall Status Unknown status
Start Date October 1, 2017
Completion Date December 2019
Primary Completion Date August 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
reducing maximum capsular thickness (MCT) 3.5 years
reduce pain 3.5 years
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexamethasone

Description: dexamethasone will be injected intracapsular under US

Arm Group Label: treatment group

Intervention Type: Device

Intervention Name: US

Description: dexamethasone will be injected intracapsular under US

Arm Group Label: treatment group

Eligibility

Criteria:

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

Gender: Female

Gender Based: Yes

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Muhammad Mansour, MD Principal Investigator Rabin Medical Center
Overall Contact

Last Name: Muhammad Mansour, MD

Phone: 972545717393

Email: [email protected]

Location
Facility: Rabin Medical Center
Location Countries

Israel

Verification Date

September 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Rabin Medical Center

Investigator Full Name: Muhamad Mansur

Investigator Title: Principal investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: treatment group

Type: Experimental

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

Patient Data Yes
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: one treatment group

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov