Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06304272
• Other study ID #: Irrigation
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Patan Academy of Health Sciences
• Contact: Ashis Shrestha, Fellow
• Phone: 9851061846
• Email: ashisshrestha[@]pahs.edu.np
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 440
• Est. completion date: December 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Trauma

Intervention

Procedure:
• Irrigating Traumatic Wound with Drinking Water
Irrigating Traumatic Wound with Drinking Water and Normal Saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Patan Academy of Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: No discharge or fever on day 3; 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

External Links

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