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临床试验/NCT05481398
NCT05481398已完成不适用

Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery: A Randomized Controlled Trial.

Murk Niaz1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年3月6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
46
试验地点
1
主要终点
Rate of incisional surgical site infections (iSSIs)

研究概览

简要总结

To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Two individuals were assigned the role of outcome assessors to examine the wound after removal of the dressing and score the wound for infection using the ASEPSIS score.

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

  • All patients undergoing elective open HPB surgery (benign or malignant disease) of age > 18 years consenting to the study protocol.

排除标准

  • The patient in which primary wound closure is not achieved. The patient planned for a second look surgery. The patient with the history of long-term antibiotic use (more than a month). Past history of open abdominal surgery (less than 1 month).

结局指标

主要结局

Rate of incisional surgical site infections (iSSIs)

时间窗: within 7 days of hepatopancreatobiliary (HPB) surgery

To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing.

次要结局

  • Surgical site complication(within 30 days of HPB surgery)
  • Antibiotic therapy(Day 1 to day 30)
  • Wound infections(day 7 till 30 days following HPB surgery)
  • Rate of fascial dehiscence(within 30 days of HPB surgery)
  • Length of hospital stay.(Day 1 to day 30)

研究者

发起方
Murk Niaz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Murk Niaz

General Surgery Resident

Sindh Institute of Urology and Transplantation

研究点 (1)

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