Back to resultsUltrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
Primary Purpose
Capsular Contracture, Implant
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Dexamethasone
US
Sponsored by
About this trial
This is an interventional treatment trial for Capsular Contracture, Implant focused on measuring breast capsular contructure
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
Sites / Locations
- Rabin Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
The treatment group will be injected with dexamethasone instracapsular under US according to our built protocol.
Outcomes
Primary Outcome Measures
reducing maximum capsular thickness (MCT)
measured by ultrasound
reduce pain
pain assessed with visual analogue score (pain-VAS).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03171974
Brief Title
Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
Official Title
Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Anticipated)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Capsular Contracture, Implant
Keywords
breast capsular contructure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
one treatment group
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
The treatment group will be injected with dexamethasone instracapsular under US according to our built protocol.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
dexamethasone will be injected intracapsular under US
Intervention Type
Device
Intervention Name(s)
US
Intervention Description
dexamethasone will be injected intracapsular under US
Primary Outcome Measure Information:
Title
reducing maximum capsular thickness (MCT)
Description
measured by ultrasound
Time Frame
3.5 years
Title
reduce pain
Description
pain assessed with visual analogue score (pain-VAS).
Time Frame
3.5 years
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Mansour, MD
Phone
972545717393
Email
Muhammad.dima@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
omri dominsky, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Mansour, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tikva
State/Province
IL
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
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