Tap Water Versus Normal Saline for Wound Irrigation

Not Applicable

Completed

• Conditions: Wound Infection Rate
• Interventions: Procedure: wound irrigation with study fluid

• Registration Number: NCT01564342
• Lead Sponsor: Stanford University

Brief Summary

This study is designed to compare the infection rates in wounds irrigated with sterile normal saline to those irrigated with chlorinated tap water. The hypothesis is that the wound infection rate subsequent to irrigation with tap water is not significantly different than the infection rate for wounds irrigated with sterile normal saline.

Inclusion criteria are patients older than 1-year of age who present to the emergency department with a soft-tissue laceration requiring repair. Exclusion criteria include patients with any underlying immunocompromising illness, current use of antibiotics, puncture or bite wounds, underlying tendon or bone involvement, or wounds more than nine hours old.

Patients are randomized to have their wounds irrigated either with tap water or sterile normal saline prior to closure, controlling for the volume and irrigation method used. Structured follow-up is completed at 48 hours and 30 days to determine the presence of infection.

The primary outcome measure is the difference in wound infection rates between the two randomized groups.

Detailed Description

Not available

Study Timeline

• Study Start: 1994-06
• Primary Completion: 1996-06
• Study Completion: 1996-06
• Status Verified: 2012-03
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Last Update Submitted: 2012-03-23
• Study First Posted: 2012-03-27
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

• Patients older than 1-year of age, who presented to the ED with an uncomplicated soft-tissue laceration requiring repair.

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Exclusion Criteria

• Diabetes mellitus
• Asplenism
• primary immune disorder
• Mechanical heart valve
• Chronic alcoholism
• Steroid use,
• Antibiotics use
• Immunosuppressive chemotherapy
• Wounds older than 9 hours or from a human or animal bite
• Puncture wounds
• Wounds associated with bone, tendon, or neurovascular injury

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
wounds irrigated with sterile normal saline	wound irrigation with study fluid	Patients in this arm had their wounds irrigated with sterile normal saline
wound irrigation with tap water	wound irrigation with study fluid	Patients in the arm had their wounds irrigated with tap water

Primary Outcome Measures

Name	Time	Method
Wound Infection at 48 hours	48 hours	The primary outcome for this study is the difference in wound infection rates between the two randomized groups. It is assessed at 48 hours

Secondary Outcome Measures

Name	Time	Method
wound infection manifest at 30 days	30 days	patients are again contacted at 30 days after repair of their wound to assess for evidence of delayed or late infections

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States