Tap Water Versus Normal Saline for Wound Irrigation
NCT01564342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 660
Last updated 2012-03-27
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.
Conditions
- Wound Infection Rate
Interventions
- PROCEDURE
-
wound irrigation with study fluid
wounds were either irrigated with sterile normal saline or tap water.
Sponsors & Collaborators
- lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1994-06-30
- Primary Completion
- 1996-06-30
- Completion
- 1996-06-30
Countries
- United States
Study Locations
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