Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
NCT ID: NCT03171974
Last Updated: 2017-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2017-10-01
2019-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment group
The treatment group will be injected with dexamethasone instracapsular under US according to our built protocol.
Dexamethasone
dexamethasone will be injected intracapsular under US
US
dexamethasone will be injected intracapsular under US
Interventions
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Dexamethasone
dexamethasone will be injected intracapsular under US
US
dexamethasone will be injected intracapsular under US
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with skin atrophy of the breast
18 Years
FEMALE
Yes
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Muhamad Mansur
Principal investigator
Principal Investigators
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Muhammad Mansour, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Rabin Medical Center
Petah Tikva, IL, Israel
Countries
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Central Contacts
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omri dominsky, MD
Role: CONTACT
Other Identifiers
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0213-17-RMC
Identifier Type: -
Identifier Source: org_study_id