NCT03171974

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Capsular Contracture, Implant

Interventions

Type	Name	Description
DRUG	Dexamethasone	dexamethasone will be injected intracapsular under US
DEVICE	US	dexamethasone will be injected intracapsular under US

Timeline

• Start date: 2017-10-01
• Primary completion: 2019-08-01
• Completion: 2019-12-01
• First posted: 2017-05-31
• Last updated: 2017-10-03

Locations

1 site across 1 country: Israel