Tap Water Versus Normal Saline for Wound Irrigation

Stanford University

Status: Completed

Conditions: Wound Infection Rate

Treatments: Procedure: wound irrigation with study fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT01564342

M1272

Details and patient eligibility

About

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.

Enrollment: 660 patients

Sex: All

Ages: 12+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

660 participants in 2 patient groups

wounds irrigated with sterile normal saline

Other group

Description:

Patients in this arm had their wounds irrigated with sterile normal saline

Treatment:

Procedure: wound irrigation with study fluid

wound irrigation with tap water

Other group

Description:

Patients in the arm had their wounds irrigated with tap water

Treatment:

Procedure: wound irrigation with study fluid