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
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
Dr ARUN KUMAR
Moti Lal Nehru Medical College, Prayagraj
