跳至主要内容
临床试验/CTRI/2024/12/078118
CTRI/2024/12/078118尚未招募4 期

Prospective randomised controlled study to evaluate the effectiveness of hypochlorous acid as a peritoneal lavage agent to prevent surgical site infection after exploratory laparotomy for perforation peritonitis

Dr Arun Kumar1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年12月26日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
144
试验地点
1
主要终点
To compare the efficacy of HOCl ( Hypochlorous acid) versus normal saline in perforation peritonitis cases in view of superficial and deep incisional SSI.

研究概览

简要总结

Surgical site infections (SSIs) are a frequent and serious complication

following abdominal surgeries, contributing to increased morbidity,

extended hospital stays and higher healthcare costs. Patients undergoing

exploratory laparotomy for perforation peritonitis face a heightened risk of

SSIs due to contamination of the peritoneal cavity by gastrointestinal

contents. One method to mitigate this risk is to lavage the intraperitoneal

cavity. Hypochlorous acid, recognized for its broad-spectrum antimicrobial

activity, biocompatibility, and potential to reduce infection rates, represents

a promising antiseptic. Utilizing it as a peritoneal lavage agent is an

innovative strategy that could yield better outcomes than traditional

methods. Conducting a randomized controlled trial (RCT) will offer robust

evidence on the efficacy and safety of hypochlorous acid in preventing SSIs.

Demonstrating its effectiveness can directly enhance patient recovery times,

alleviate pain and discomfort, and improve overall post-surgery quality of life.

By potentially reducing the incidence of SSIs, the study can also promote

more cost-effective healthcare by decreasing the need for extended

treatments and readmissions. Positive outcomes could influence surgical

protocols and guidelines, supporting the integration of hypochlorous acid

into clinical practice. Additionally, the findings could pave the way for further

research into other uses of hypochlorous acid across various surgical and

wound care contexts. Addressing SSIs, a prevalent public health issue, the

study can contribute to better health outcomes and reduce the healthcare

system’s burden.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Dirty wound (class- IV)according to CDC classification.
  • • Emergency surgery by midline or transverse laparotomy for perforation peritonitis .
  • • Age ≥ 18 years.
  • • American society of anaesthesiologists (ASA) score ≤
  • • Ability to understand the nature and extent of the study and to give written informed consent.

排除标准

  • 未提供

结局指标

主要结局

To compare the efficacy of HOCl ( Hypochlorous acid) versus normal saline in perforation peritonitis cases in view of superficial and deep incisional SSI.

时间窗: 30 days

次要结局

  • To determine the safety profile of HOCI in peritoneal lavage.(30 days)

研究者

发起方
Dr Arun Kumar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr ARUN KUMAR

Moti Lal Nehru Medical College, Prayagraj

研究点 (1)

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