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

Capsular Contracture, Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03171974
• Other study ID #: 0213-17-RMC
• Status: Not yet recruiting
• Phase: N/A
• First received: May 24, 2017
• Last updated: September 30, 2017
• Start date: October 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: September 2017
• Source: Rabin Medical Center
• Contact: Muhammad Mansour, MD
• Phone: 972545717393
• Email: ?Muhammad.dima[@]gmail.com?
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Capsular Contracture, Implant
• Contracture
• Implant Capsular Contracture

Intervention

Drug:
• Dexamethasone
dexamethasone will be injected intracapsular under US

Device:
• US
dexamethasone will be injected intracapsular under US

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikva	IL

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reducing maximum capsular thickness (MCT)	measured by ultrasound	3.5 years
Primary	reduce pain	pain assessed with visual analogue score (pain-VAS).	3.5 years