Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- reducing maximum capsular thickness (MCT)
研究概览
简要总结
Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female patient with grade 3-4 capsular contraction after alloplastic breast reconstruction\ augmentation
排除标准
- •intake of steroids, anti-inflammatory, anti-coagulate or immunomodulatory medications on a regular basis
- •Patients with skin atrophy of the breast
研究组 & 干预措施
treatment group
The treatment group will be injected with dexamethasone instracapsular under US according to our built protocol.
干预措施: Dexamethasone (Drug)
treatment group
The treatment group will be injected with dexamethasone instracapsular under US according to our built protocol.
干预措施: US (Device)
结局指标
主要结局
reducing maximum capsular thickness (MCT)
时间窗: 3.5 years
measured by ultrasound
reduce pain
时间窗: 3.5 years
pain assessed with visual analogue score (pain-VAS).
次要结局
未报告次要终点
研究者
Muhamad Mansur
Principal investigator
Rabin Medical Center
