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临床试验/CTRI/2024/09/074165
CTRI/2024/09/074165尚未招募不适用

Comparison of surgical site infection between negative pressure wound therapy and standard dressing on closed midline incisions in Class 3 and 4 abdominal surgical wounds: A Randomized control trial

Lady hardinge medical college New Delhi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Incidence of surgical site infection (SSI) between negative pressure wound therapy (NPWT) versus standard dressings in closed midline incisions in patients undergoing laparotomy with class 3 and 4 abdominal surgical wounds

研究概览

简要总结

Despite peri-operative preventive measures to minimize the risk of SSI, such as hand hygiene of the surgical team, antibiotic prophylaxis, skin preparation, and sterile drapes and gowns SSI remains a challenging problem to surgeons and patients worldwide.SSIs prolong hospitalization, increase the risk of morbidity and mortality and need for repeat surgery thereby increasing healthcare costs and form a major burden on the health infrastructure.

Prophylactic negative pressure wound therapy (pNPWT) uses a closed, sealed device that is packed with porous foam or gauze dressing and sealed with an occlusive drape and continuous negative pressure rates of between-50 to -125 mm Hg maintained by connecting suction tubes to the dressing .It enhances wound healing by reducing dead space, oedema and exudates , hastening granulation tissue formation, decreasing bacterial burden, providing a moist wound healing environment and increasing blood circulation by angiogenesis.

WHO panel guidelines suggest the use of negative pressure wound therapy (NPWT) in adult patients on primarily closed surgical incisions in high-risk wounds, for the purpose of the prevention of SSI.

Justification:While there has been extensive research on the beneficial effects of negative pressure wound therapy on open wounds such as diabetic foot and non-healing ulcers, there are few studies which evaluated the effects of negative pressure wound therapy on closed midline incisions in patients undergoing laparotomy with grossly contaminated abdominal surgeries

Standard dressing involves use of dry sterile gauge pieces. WHO panel suggests against using any type of advanced dressings over a standard dressing on primarily closed surgical wounds for the purpose of preventing SSI.

Although the use of NPWT has conventionally been researched in open wounds, their use on closed laparotomy wounds has been found to be associated with a significant reduction in SSI rates.This will lead to a reduction in the overall economic burden and complications following laparotomy by decreasing length of hospital stay and reducing the number of readmissions and need for re-exploration

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.All Adult patients undergoing laparotomy with midline incisions with class 3 surgical midline wounds.

排除标准

  • 1.Women with pregnancy 2.Patients allergic to adhesive materials 3.Patients undergoing reexploration for complications of previous surgery.

结局指标

主要结局

Incidence of surgical site infection (SSI) between negative pressure wound therapy (NPWT) versus standard dressings in closed midline incisions in patients undergoing laparotomy with class 3 and 4 abdominal surgical wounds

时间窗: 1.Post op day 5 or earlier as determined by physician. | 2.weekly till Post op day 30

次要结局

  • Wound complications (i.e., dehiscence, hematoma, bleeding, seroma, blisters) between negative pressure wound therapy (NPWT) versus standard dressings in closed midline incisions in patients undergoing laparotomy with class 3 and 4 abdominal surgical wounds(POD 1-5)
  • Length of hospital stay between negative pressure wound therapy (NPWT) versus standard dressings in closed midline incisions in patients undergoing laparotomy with class 3 and 4 abdominal surgical wounds(until discharge)
  • Number of patients who required hospital readmissions within 30 days between negative pressure wound therapy (NPWT) versus standard dressings in closed midline incisions in patients undergoing laparotomy with class 3 and 4 abdominal surgical wounds.(POD30)

研究者

发起方
Lady hardinge medical college New Delhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Manav Bansal

Lady Hardinge Medical College

研究点 (1)

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