Tap Water Versus Normal Saline for Wound Irrigation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01564342
First received: March 22, 2012
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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 Intervention
Wound Infection Rate
Procedure: wound irrigation with study fluid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Wound Infection at 48 hours [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    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:
  • wound infection manifest at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    patients are again contacted at 30 days after repair of their wound to assess for evidence of delayed or late infections


Enrollment: 660
Study Start Date: June 1994
Study Completion Date: June 1996
Primary Completion Date: June 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564342

Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01564342     History of Changes
Other Study ID Numbers: M1272
Study First Received: March 22, 2012
Last Updated: March 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
wound irrigation
tap water irrigation
wound infection
wound irrigation solution

Additional relevant MeSH terms:
Infection
Wound Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014