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临床试验/NCT06304272
NCT06304272尚未招募不适用

Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound: Noninferiority Trial

Patan Academy of Health Sciences0 个研究点目标入组 440 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
440
主要终点
Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial.

研究概览

简要总结

There is a controversy regarding the roles of the Normal saline and Tap water in irrigation of the wound. It has been suggested that antiseptic solution including normal saline has cytotoxic effect while tap water damages the fibroblast. There are no high level evidence to support one type of solution over other, systematic review have found no difference in wound infection between irrigation with normal saline vs tap water. There are ten randomized controlled trial comparing tap water with normal saline for irrigating wound published between 1992 to 2016. These RCT are analyzed in three systemic review and meta-analysis published on 2016, 2019, 2022, which showed that tap water and normal saline has no difference in terms of infection rate. The infection rate observed in various studies ranges from 0-11.5% in normal saline group and 0-12.6% in tap water group with no statistically significant difference.

详细描述

There is a controversy regarding the roles of the Normal saline and Tap water in irrigation of the wound. It has been suggested that antiseptic solution including normal saline has cytotoxic effect while tap water damages the fibroblast. There are no high level evidence to support one type of solution over other, systematic review have found no difference in wound infection between irrigation with normal saline vs tap water. There are ten randomized controlled trial comparing tap water with normal saline for irrigating wound published between 1992 to 2016. These RCT are analyzed in three systemic review and meta-analysis published on 2016, 2019, 2022, which showed that tap water and normal saline has no difference in terms of infection rate. The infection rate observed in various studies ranges from 0-11.5% in normal saline group and 0-12.6% in tap water group with no statistically significant difference.

The published study has looked into tap water which may not be equivalent to drinking water in our setup, therefore the investigators are looking into drinking water that is bacteriologically safe. Out of published RCTs there is only one done in acute traumatic wound with good sample size and study design. This study is purposed to look into acute traumatic wound with proper randomization, allocation and concealment. Moreover, this is a non-inferiority trial, therefore if it is proven that drinking water is non-inferior to normal saline then, it will be easily available modality of wound irrigation in Low-Middle-Income country like Nepal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Laceration wound presenting within 6 hours of duration
  • •Lacerations involving upper and lower limbs, scalps, head and neck

排除标准

  • •Lacerations involving, lips, ears, mucosal surface, perineal and peri anal region
  • •Punctured or penetrating wound
  • •Bite wounds by human or animals or snakes
  • •Dirty wound requiring surgical debridement
  • •Patient requiring irrigation of wound with more than 1 liter of fluid
  • •Wounds involving tendon, joint or bone
  • •Wound associated with open fracture
  • •Patient on corticosteroid, antibiotics or immunosuppressant
  • •Patient who are not able to come for follow-up
  • •Immunocompromised patient
  • •Patient with history of significant peripheral vascular disease

研究组 & 干预措施

Irrigating Traumatic Wound with Drinking Water

Experimental

In drinking water arm, acute traumatic wound will be cleaned with drinking water. Bacteriological safety of the drinking water will be ensured by testing water.

干预措施: Irrigating Traumatic Wound with Drinking Water (Procedure)

Irrigating Traumatic Wound with Normal Saline

Experimental

In normal saline arm, acute traumatic wound will be cleaned with normal saline.

干预措施: Irrigating Traumatic Wound with Drinking Water (Procedure)

结局指标

主要结局

Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial.

时间窗: 3-7 Days

Difference in wound infection rates between the two randomized groups. Wound evaluation was based on the following criteria No infection: 1. No discharge or fever on day 3 2. Dry and no fever on day 7 Infection 1\. Fever greater than 1000 F or pus discharge on any day 2. Erythema with serous discharge on any day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashis Shrestha

Assistant Professor

Patan Academy of Health Sciences

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