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临床试验/NCT03171974
NCT03171974Unknown不适用

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

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

The treatment group will be injected with dexamethasone instracapsular under US according to our built protocol.

干预措施: Dexamethasone (Drug)

treatment group

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhamad Mansur

Principal investigator

Rabin Medical Center

研究点 (1)

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