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OpenTrials
Completed

NCT Number: NCT01564342

Tap Water Versus Normal Saline for Wound Irrigation

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.

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Key information

Conditions

Wound Infection Rate Infections Wound Infection

Age range

12 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Medical Center

Stanford, California, 94305, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wound irrigation with study fluid

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
1994
Primary completion
1996
Study completion
1996
First posted
Mar 27, 2012
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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