Tap Water Versus Normal Saline for Wound Irrigation

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management

Conditions
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Wound Infection Rate

Intervention / Treatment
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* Procedure: wound irrigation with study fluid


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

Ages Eligible for Study
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Minimum Age: 12 Months

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: wounds irrigated with sterile normal saline<br>Patients in this arm had their wounds irrigated with sterile normal saline | Procedure: wound irrigation with study fluid<br>* wounds were either irrigated with sterile normal saline or tap water.<br>|
| Other: wound irrigation with tap water<br>Patients in the arm had their wounds irrigated with tap water | Procedure: wound irrigation with study fluid<br>* wounds were either irrigated with sterile normal saline or tap water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Infection at 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 | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound infection manifest at 30 days | patients are again contacted at 30 days after repair of their wound to assess for evidence of delayed or late infections | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound irrigation, tap water irrigation, wound infection, wound irrigation solution