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临床试验/NCT03703661
NCT03703661Unknown3 期

Can a Low Cost, Simple Needle-Aspirated Compression Dressing Reduce Surgical Site Infection Rates of Primarily Closed Ileostomy and Colostomy Reversal Wounds?

University of Southern California2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2017年8月27日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
122
试验地点
2
主要终点
Surgical Site Infection

研究概览

简要总结

Negative pressure wound dressings have been studied and shown to have applications in decreasing rates of surgical wound infections. This study studies the effect of a low cost needle-aspirated negative pressure compression dressing on rates of wound infection at prior ostomy site in patients undergoing ostomy reversal surgery.

详细描述

Negative Pressure Wound Therapy (NPWT) will be studied in colorectal surgery patients undergoing ostomy reversal surgery. The immediate goal is to compare primary wound closure against primary closure with needle-aspirated compression dressing, and determine if risk of potential ostomy site wound infections is decreased. The investigators would also like to evaluate if this compression dressing can increase prevalence of complete wound closure by 12 weeks (last planned clinic visit). NPWT using a continuous suction device was shown to decrease surgical site infection (SSI) at ostomy reversal sites undergoing primary closure. There is a lack of published literature studying NPWT dressings without an associated suction device. The investigators will be using a low-cost simple needle-aspirated suction technique to provide negative pressure under a tegaderm/gauze dressing, at the time of placement. Patients will be consented and randomized into a negative pressure group, or a control group consisting of the same dressing under normal pressure. All adult patients undergoing ostomy reversal surgery who consent to the study will be included. Exclusion criteria include prior recurrent skin infections, prior stoma-site infection, or large parastomal hernia. Patients in the negative pressure group will have the pressure under the dressing measured immediately prior to removal on post-operative day 2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 18 years of age
  • presence of a loop or end colostomy or ileostomy
  • consenting to study and to ostomy reversal

排除标准

  • altered mental status or patients unable to sign the informed consent form
  • vulnerable patient populations such as prison and ward patients
  • patients who are discovered before or during surgery as unable to undergo placement of compression dressing will be excluded.
  • Patients with visible protrusion/evidence of large parastomal hernia
  • history of recurrent skin & soft tissue infections
  • history of previous stoma site infection or complications
  • patients with extensive comorbidities (such as cancer involving stoma site, uncontrolled diabetes, etc), Crohn's patients and abdominal wall fistula patients
  • patients in who primary closure of wound is deemed inappropriate by the operating surgeon, requiring a different method of stoma site wound management

研究组 & 干预措施

Control

Other

primary closure with gauze and adhesive/occlusive dressing

干预措施: Control (Procedure)

Negative Pressure

Experimental

primary closure with gauze and adhesive/occlusive dressing under negative pressure

干预措施: Needle-Aspirated Negative Pressure Dressing (Procedure)

结局指标

主要结局

Surgical Site Infection

时间窗: 30 days post procedure

Surgical Site Infection

次要结局

  • Rate of Wound Closure(3 weeks post procedure and 12 weeks post procedure)

研究者

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

Sang Won Lee

Professor of Clinical Surgery, Chief, Division of Colorectal Surgery

University of Southern California

研究点 (2)

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