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临床试验/NCT02302001
NCT02302001已完成不适用

Breast Augmentation Using Novel Method of Jet Hydro Dissection Effects on Postoperative Pain

Aristocrat Plastic Surgery and MedAesthetics3 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
3
主要终点
Decreased postoperative pain and recovery after breast augmentation

研究概览

简要总结

ERBEjet Breast augmentation is a novel method of dissection of the subpectoral pocket. Study is designed to differentiate parameters of pain between randomized laterality using no touch technique. THIS IS NOT A FREE STUDY. Patients are required to pay the initial cost of surgery but will receive a refund of a partial payment. Patients must undergo evaluation at consultation and surgical quote is provided.

详细描述

Breast augmentation in the subpectoral position has classically been associated with postoperative pain and discomfort within the first two weeks after the operation. Minimizing this pain and discomfort and ability to return to normal function soon after the operation has been the goal of numerous interventions. Minimal injury no touch dissection techniques have proven results regarding morbidity. ERBEjet is a novel dissection using a jet of local anesthetic infused saline fluid with a built in coagulation function used for dissection of soft tissues. The study is designed to randomly perform ERBEjet Breast augmentation operation unilaterally on breast augmentation and mastopexy augmentation patients undergoing traditional sub pectoral dissection technique on the contralateral side. Patient's record pain scores at regular intervals in the postoperative period. Physical examination performed by blinded practitioners assess discomfort and tenderness scores within the two weeks after the operation.

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
22 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • silicone breast implants candidate

排除标准

  • history of breast cancer
  • inability to conform to post operative questionnaire and recovery follow up

结局指标

主要结局

Decreased postoperative pain and recovery after breast augmentation

时间窗: Two weeks

次要结局

  • Decreased risk of capsular contracture(Three months)

研究者

发起方
Aristocrat Plastic Surgery and MedAesthetics
申办方类型
Other
责任方
Sponsor

研究点 (3)

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