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临床试验/NCT01002391
NCT01002391已完成不适用

Twenty-four Hours or 6 Days? A Prospective Randomized Trial Comparing Dressing Wear Time After Reduction Mammaplasty

Daniela Francescato Veiga2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2009年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
surgical site infection

研究概览

简要总结

This study was designed to determine whether the duration of dressing wear following reduction mammaplasty influence skin colonization and surgical site infections rates.

详细描述

Surgical site infections (SSI) are wound infections that occur after invasive procedures.Particularly in plastic surgery procedures, to minimize the risk of SSI is imperative, since even minor infections are able to complicate the healing process and harm the cosmetic result.

Reduction mammaplasty is an effective and well established procedure performed for the relief of physical pain and discomfort associated with macromastia, which significantly decreases patients' quality of life.Breast reduction has provided long-term relief for most patients, with high patient satisfaction.

The demand for this kind of plastic surgery is high.Reduction mammaplasty was the fifth most commonly surgical procedure performed by plastic surgeons in women of United States.Since reduction mammaplasty is associated with a high incidence of wound problems,all effort to minimize the risk of SSI is valid.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • breast hypertrophy
  • candidate to reduction mammaplasty
  • body mass index under 30Kg/m2

排除标准

  • pregnancy, delivery or breast feeding during the last 12 months
  • body mass index over 30Kg/m2
  • breast cancer history
  • previous breast surgery
  • hard smoking

研究组 & 干预措施

Postoperative day 1

Experimental

Dressing is removed on the first postoperative day

干预措施: reduction mammaplasty (Procedure)

Postoperative day 6

Experimental

Dressing is removed on the sixth postoperative day

干预措施: reduction mammaplasty (Procedure)

结局指标

主要结局

surgical site infection

时间窗: 30 days postoperatively

次要结局

  • skin colonization(6 days postoperatively)

研究者

发起方
Daniela Francescato Veiga
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniela Francescato Veiga

Professor

Federal University of São Paulo

研究点 (2)

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