Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound

NCT ID: NCT06304272

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double blinded, parallel, non-inferiority trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Irrigating Traumatic Wound with Drinking Water

Intervention Type PROCEDURE

Irrigating Traumatic Wound with Drinking Water and Normal Saline

Irrigating Traumatic Wound with Normal Saline

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

Group Type EXPERIMENTAL

Irrigating Traumatic Wound with Drinking Water

Intervention Type PROCEDURE

Irrigating Traumatic Wound with Drinking Water and Normal Saline

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Irrigating Traumatic Wound with Drinking Water

Irrigating Traumatic Wound with Drinking Water and Normal Saline

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Irrigating Traumatic Wound with Normal Saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Patan Academy of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ashis Shrestha

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ashis Shrestha, Fellow

Role: PRINCIPAL_INVESTIGATOR

Patan Academy of Health Sciences

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ashis Shrestha, Fellow

Role: CONTACT

9851061846

Sumana Bajracharya, Fellow

Role: CONTACT

9841359823

Related Links

Access external resources that provide additional context or updates about the study.

https://pubmed.ncbi.nlm.nih.gov/2344089/

The Effects of Wound Lavage Solutions on Canine Fibroblasts: An In Vitro Study

https://pubmed.ncbi.nlm.nih.gov/12964289/

Is tap water a safe alternative to normal saline for wound irrigation in the community setting?

https://pubmed.ncbi.nlm.nih.gov/23325896/

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

https://www.redalyc.org/pdf/3882/388245833001.pdf

The effectiveness of cleansing solution for wound treatment A systematic review

https://pubmed.ncbi.nlm.nih.gov/30191654/

Comparison of wounds' infection rate between tap water and normal saline cleansing: A meta-analysis of randomised control trials

https://pubmed.ncbi.nlm.nih.gov/17456554/

A Multicenter Comparison of Tap Water versus Sterile Saline for Wound Irrigation

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Irrigation

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.