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

Sponsor

Rabin Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03171974

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Capsular Contracture, Implant	Drug: Dexamethasone Device: US	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

one treatment groupone treatment group

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2017

Anticipated Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment group The treatment group will be injected with dexamethasone instracapsular under US according to our built protocol.	Drug: Dexamethasone dexamethasone will be injected intracapsular under US Device: US dexamethasone will be injected intracapsular under US

Arm

Intervention/Treatment

Experimental: treatment group

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

Drug: Dexamethasone

dexamethasone will be injected intracapsular under US

Device: US

dexamethasone will be injected intracapsular under US

Outcome Measures

Primary Outcome Measures

reducing maximum capsular thickness (MCT) [3.5 years]
measured by ultrasound
reduce pain [3.5 years]
pain assessed with visual analogue score (pain-VAS).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center	Petach Tikva	IL	Israel

Sponsors and Collaborators

Rabin Medical Center

Investigators

Principal Investigator: Muhammad Mansour, MD, Rabin Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muhamad Mansur, Principal investigator, Rabin Medical Center

ClinicalTrials.gov Identifier:

NCT03171974

Other Study ID Numbers:

0213-17-RMC

First Posted:

May 31, 2017

Last Update Posted:

Oct 3, 2017

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Muhamad Mansur, Principal investigator, Rabin Medical Center

breast capsular contructure

Additional relevant MeSH terms:

Contracture

Implant Capsular Contracture

Dexamethasone

Study Results

No Results Posted as of Oct 3, 2017