Study Results
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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COMPLETED
NA
660 participants
INTERVENTIONAL
1994-06-30
1996-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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wounds irrigated with sterile normal saline
Patients in this arm had their wounds irrigated with sterile normal saline
wound irrigation with study fluid
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
wound irrigation with study fluid
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
12 Months
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Locations
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Stanford University Medical Center
Stanford, California, United States
Countries
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Other Identifiers
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M1272
Identifier Type: -
Identifier Source: org_study_id
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