Wound Infection Rate Clinical Trial
Official title:
A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management
| Verified date | March 2012 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 660 |
| Est. completion date | June 1996 |
| Est. primary completion date | June 1996 |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 12 Months and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Stanford University Medical Center | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Stanford University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Wound Infection at 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 | 48 hours | Yes |
| Secondary | wound infection manifest at 30 days | patients are again contacted at 30 days after repair of their wound to assess for evidence of delayed or late infections | 30 days | Yes |