Tap Water Versus Normal Saline for Wound Irrigation

• ClinicalTrials.gov Identifier: NCT01564342
• Recruitment Status: Completed
• First Posted: March 27, 2012
• Last Update Posted: March 27, 2012
• Sponsor: Stanford University
• Information provided by (Responsible Party): Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Wound Infection Rate	Procedure: wound irrigation with study fluid	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 660 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management
• Study Start Date: June 1994
• Actual Primary Completion Date: June 1996
• Actual Study Completion Date: June 1996

Arms and Interventions

Arm	Intervention/treatment
wounds irrigated with sterile normal saline; Patients in this arm had their wounds irrigated with sterile normal saline	Procedure: wound irrigation with study fluid; wounds were either irrigated with sterile normal saline or tap water.
wound irrigation with tap water; Patients in the arm had their wounds irrigated with tap water	Procedure: wound irrigation with study fluid; wounds were either irrigated with sterile normal saline or tap water.

Outcome Measures

Primary Outcome Measures :

1. Wound Infection at 48 hours [ Time Frame: 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 Outcome Measures :

1. wound infection manifest at 30 days [ Time Frame: 30 days ]
   patients are again contacted at 30 days after repair of their wound to assess for evidence of delayed or late infections

Eligibility Criteria

• Ages Eligible for Study: 12 Months and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All

Criteria

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

Contacts and Locations

Locations

United States, California

Stanford University Medical Center

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

More Information

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT01564342
• Other Study ID Numbers: M1272
• First Posted: March 27, 2012
• Last Update Posted: March 27, 2012
• Last Verified: March 2012

Keywords provided by Stanford University:

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

Additional relevant MeSH terms:

Wound Infection; Wounds and Injuries; Infection