Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound

NCT06304272 | Not Yet Recruiting

• 1 other identifier: Irrigation
• Study Type: interventional
• Target: 440
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Trauma

Keywords

Traumatic Wound; Wound Infection

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (2)

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.

Procedure: Irrigating Traumatic Wound with Drinking Water

Irrigating Traumatic Wound with Normal Saline

EXPERIMENTAL

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

Procedure: Irrigating Traumatic Wound with Drinking Water

Interventions

Irrigating Traumatic Wound with Drinking Water PROCEDURE

Irrigating Traumatic Wound with Drinking Water and Normal Saline

Also known as: Irrigating Traumatic Wound with Normal Saline

Irrigating Traumatic Wound with Drinking Water; Irrigating Traumatic Wound with Normal Saline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Patan Academy of Health Sciences: lead

Related Links

• The Effects of Wound Lavage Solutions on Canine Fibroblasts: An In Vitro Study
• Is tap water a safe alternative to normal saline for wound irrigation in the community setting?
• Water is a safe and effective alternative to sterile normal saline for wound irrigation prior to suturing: a prospective, double-blind, randomised, controlled clinical trial
• The effectiveness of cleansing solution for wound treatment A systematic review
• Comparison of wounds' infection rate between tap water and normal saline cleansing: A meta-analysis of randomised control trials
• Water for wound cleansing
• A Multicenter Comparison of Tap Water versus Sterile Saline for Wound Irrigation
• Injury, fatal and nonfatal: Sharp and cutting-edge wounds
• Wound classification

MeSH Terms

Conditions

Wounds and Injuries; Wound Infection

Interventions

Drinking Water; Saline Solution

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ashis Shrestha, Fellow

  Patan Academy of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashis Shrestha, Fellow

CONTACT

9851061846; ashisshrestha@pahs.edu.np

Sumana Bajracharya, Fellow

CONTACT

9841359823; sumanabajracharya@pahs.edu.np

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, double blinded, parallel, non-inferiority trial

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 12, 2024

Record last verified: 2024-03