Capsular Contracture, Implant Clinical Trial
Official title:
Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
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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Status | Clinical Trial | Phase | |
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Completed |
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Recruiting |
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