Tap Water Versus Normal Saline for Wound Irrigation

NCT01564342 | Completed

• 1 other identifier: M1272
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Infection Rate

Keywords

wound irrigation; tap water irrigation; wound infection; wound irrigation solution

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• wound infection manifest at 30 days

  30 days

Study Arms (2)

wounds irrigated with sterile normal saline

OTHER

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

Procedure: wound irrigation with study fluid

wound irrigation with tap water

OTHER

Patients in the arm had their wounds irrigated with tap water

Procedure: wound irrigation with study fluid

Interventions

wound irrigation with study fluid PROCEDURE

wounds were either irrigated with sterile normal saline or tap water.

wound irrigation with tap water; wounds irrigated with sterile normal saline

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 1-year of age, who presented to the ED with an uncomplicated soft-tissue laceration requiring repair.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 27, 2012
• Study Start: June 1, 1994
• Primary Completion: June 1, 1996
• Study Completion: June 1, 1996
• Last Updated: March 27, 2012

Record last verified: 2012-03

Locations

US (1)