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临床试验/CTRI/2025/02/080665
CTRI/2025/02/080665尚未招募Phase 3 4

Assessing the impact of Intraoperative wound irrigation (IOWI) with Normal saline on incisional surgical site infections (SSI) in patients with laparotomy abdominal incisional wounds when compared to no irrigation: A two arm parallel randomized control trial at a tertiary care centre.

All India Institute Of Medical Sciences Raipur Chhattisgarh1 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2025年2月28日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
244
试验地点
1
主要终点
Incidence of surgical site infection will be assessed in patients with abdominal laparotomy wound

研究概览

简要总结

All the patients undergoing Abdominal surgeries in the department of General Surgery, Obstetrics and gynaecology will be recruited in this study. After taking informed consent a detailed case proforma will be filled with relevant details and parameters as per study protocol. All patients will receive preop antibiotics as per the antibiotic policy of the hospital. All the patients will have their peritoneum closed as usual and before skin closure sequentially numbered opaque sealed envelope will be opened to reveal allocation, whether group A or group B

• In Group A, wound irrigation will be done with normal saline

• In Group B, wound will not be irrigated with normal saline

• Post surgery follow up will be monitored and recorded for SSI according to CDC guidelines

• The details of the participants will entered in the clear case record proforma

• The follow up will be done till POD-30

• In case of early discharge the patient will be seen in the OPD or if not mandatory on OPD when scheduled, they will be followed telephonically

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients aged 18 years and more
  • Abdominal wounds after rectus sheath closure.

排除标准

  • Relaparotomy wounds in the same hospital stay/admission
  • Abdominal/ laparotomy wound where delayed primary closure is done.

结局指标

主要结局

Incidence of surgical site infection will be assessed in patients with abdominal laparotomy wound

时间窗: Post operative day 1,2,3,4,5,30 and at the time of discharge and suture removal

次要结局

  • 1. Length of hospital stay(2. Pain score using VAS)

研究者

发起方
All India Institute Of Medical Sciences Raipur Chhattisgarh
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Moonmoon Kedia

AIIMS, Raipur

研究点 (1)

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