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Tap Water Versus Normal Saline for Wound Irrigation

Primary Purpose

Wound Infection Rate

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
wound irrigation with study fluid
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Infection Rate focused on measuring wound irrigation, tap water irrigation, wound infection, wound irrigation solution

Eligibility Criteria

12 Months - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

  • Stanford University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

wounds irrigated with sterile normal saline

wound irrigation with tap water

Arm Description

Patients in this arm had their wounds irrigated with sterile normal saline

Patients in the arm had their wounds irrigated with tap water

Outcomes

Primary Outcome Measures

Wound Infection at 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

wound infection manifest at 30 days
patients are again contacted at 30 days after repair of their wound to assess for evidence of delayed or late infections

Full Information

First Posted
March 22, 2012
Last Updated
March 23, 2012
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01564342
Brief Title
Tap Water Versus Normal Saline for Wound Irrigation
Official Title
A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 1994 (undefined)
Primary Completion Date
June 1996 (Actual)
Study Completion Date
June 1996 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection Rate
Keywords
wound irrigation, tap water irrigation, wound infection, wound irrigation solution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
wounds irrigated with sterile normal saline
Arm Type
Other
Arm Description
Patients in this arm had their wounds irrigated with sterile normal saline
Arm Title
wound irrigation with tap water
Arm Type
Other
Arm Description
Patients in the arm had their wounds irrigated with tap water
Intervention Type
Procedure
Intervention Name(s)
wound irrigation with study fluid
Intervention Description
wounds were either irrigated with sterile normal saline or tap water.
Primary Outcome Measure Information:
Title
Wound Infection at 48 hours
Description
The primary outcome for this study is the difference in wound infection rates between the two randomized groups. It is assessed at 48 hours
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
wound infection manifest at 30 days
Description
patients are again contacted at 30 days after repair of their wound to assess for evidence of delayed or late infections
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Eligibility 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
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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