Tap Water Versus Normal Saline for Wound Irrigation

NCT ID: NCT01564342

Last Updated: 2012-03-27

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-06-30

Study Completion Date

1996-06-30

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.

Detailed Description

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Conditions

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Wound Infection Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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wounds irrigated with sterile normal saline

Patients in this arm had their wounds irrigated with sterile normal saline

Group Type OTHER

wound irrigation with study fluid

Intervention Type PROCEDURE

wounds were either irrigated with sterile normal saline or tap water.

wound irrigation with tap water

Patients in the arm had their wounds irrigated with tap water

Group Type OTHER

wound irrigation with study fluid

Intervention Type PROCEDURE

wounds were either irrigated with sterile normal saline or tap water.

Interventions

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wound irrigation with study fluid

wounds were either irrigated with sterile normal saline or tap water.

Intervention Type PROCEDURE

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
Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stanford University Medical Center

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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M1272

Identifier Type: -

Identifier Source: org_study_id

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