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Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | The treatment group will be injected with dexamethasone instracapsular under US according to our built protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | dexamethasone will be injected intracapsular under US |
| |
| Measure | Description | Time Frame |
|---|---|---|
| reducing maximum capsular thickness (MCT) | measured by ultrasound | 3.5 years |
| reduce pain | pain assessed with visual analogue score (pain-VAS). | 3.5 years |
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Inclusion Criteria:
• female patient with grade 3-4 capsular contraction after alloplastic breast reconstruction\ augmentation
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Mansour, MD | Contact | 972545717393 | ‫Muhammad.dima@gmail.com‬ | |
| omri dominsky, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Muhammad Mansour, MD | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | IL | Israel |
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| ID | Term |
|---|---|
| D057910 | Implant Capsular Contracture |
| ID | Term |
|---|---|
| D005549 | Foreign-Body Reaction |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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one treatment group
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| US |
| Device |
dexamethasone will be injected intracapsular under US |
|
| D011475 | Prosthesis Failure |
| D011183 | Postoperative Complications |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |