Wound Infection Rate Clinical Trial
Official title:
A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management
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.
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment