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NCT Number: NCT06304272

Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irrigating Traumatic Wound with Drinking Water

Procedure

Irrigating Traumatic Wound with Drinking Water and Normal Saline

Other names: Irrigating Traumatic Wound with Normal Saline

Primary outcomes

  1. 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:

    • No discharge or fever on day 3
    • Dry and no fever on day 7 Infection
    • Fever greater than 1000 F or pus discharge on any day 2. Erythema with serous discharge on any day

Study contacts

Contact information is provided by the study sponsor or research team.

Ashis Shrestha, Fellow

CONTACT

[email protected]

9851061846

Sumana Bajracharya, Fellow

CONTACT

[email protected]

9841359823

Sponsors and collaborators

Lead sponsor

Patan Academy of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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