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Tap Water Versus Normal Saline for Wound Irrigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564342
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE March 27, 2012
Last Update Posted Date March 27, 2012
Study Start Date  ICMJE June 1994
Actual Primary Completion Date June 1996   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tap Water Versus Normal Saline for Wound Irrigation
Official Title  ICMJE A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Wound Infection Rate
Intervention  ICMJE Procedure: wound irrigation with study fluid
wounds were either irrigated with sterile normal saline or tap water.
Study Arms  ICMJE
  • wounds irrigated with sterile normal saline
    Patients in this arm had their wounds irrigated with sterile normal saline
    Intervention: Procedure: wound irrigation with study fluid
  • wound irrigation with tap water
    Patients in the arm had their wounds irrigated with tap water
    Intervention: Procedure: wound irrigation with study fluid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2012)
660
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1996
Actual Primary Completion Date June 1996   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01564342
Other Study ID Numbers  ICMJE M1272
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP