Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound

March 4, 2024 updated by: Ashis Shrestha, Patan Academy of Health Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Irrigating Traumatic Wound with Drinking Water
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.
Procedure: Irrigating Traumatic Wound with Drinking Water
Irrigating Traumatic Wound with Drinking Water and Normal Saline
Other Names:
  • Irrigating Traumatic Wound with Normal Saline
Experimental: Irrigating Traumatic Wound with Normal Saline
In normal saline arm, acute traumatic wound will be cleaned with normal saline.
Procedure: Irrigating Traumatic Wound with Drinking Water
Irrigating Traumatic Wound with Drinking Water and Normal Saline
Other Names:
  • Irrigating Traumatic Wound with Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial.
Time Frame: 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
3-7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patan Academy of Health Sciences

Investigators

  • Principal Investigator: Ashis Shrestha, Fellow, Patan Academy of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Irrigation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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