Wound Infection Rate
Conditions
Keywords
wound irrigation, tap water irrigation, wound infection, wound irrigation solution
Brief 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.
Interventions
PROCEDUREwound irrigation with study fluid
wounds were either irrigated with sterile normal saline or tap water.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Infection at 48 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| wound infection manifest at 30 days | 30 days | patients are again contacted at 30 days after repair of their wound to assess for evidence of delayed or late infections |
Countries
United States
Outcome results
None listed