NCT01564342

A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management

Completed NA Last updated 23 March 2012

What this trial tests

NA trial testing wound irrigation with study fluid in Wound Infection Rate in 660 participants. Completed in 1 June 1996.

Timeline

1 June 1994

Primary endpoint
1 June 1996

1 June 1996

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	660
Start date	1 June 1994
Primary completion	1 June 1996
Estimated completion	1 June 1996
Sites	1 location across United States

Drugs / interventions tested

• wound irrigation with study fluid

Conditions studied

• Wound Infection Rate — all drugs for Wound Infection Rate →

Sponsor

Stanford University

Who can join

12 Months and older, any sex, with Wound Infection Rate.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Water is a safe and effective alternative to sterile normal saline for wound irrigation prior to suturing: a prospective, double-blind, randomised, controlled clinical trial.
   Weiss EA, Oldham G, Lin M, Foster T, et al · · 2013 · cited 19× · PMID 23325896 · DOI 10.1136/bmjopen-2012-001504