Wound Infection RateNCT01564342
Tap Water Versus Normal Saline for Wound Irrigation
A study testing wound irrigation with study fluid in people with Wound Infection Rate, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Wound Infection Rate
- What is being tested?
- wound irrigation with study fluid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1994to Jun 1996
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients older than 1-year of age, who presented to the ED with an uncomplicated soft-tissue laceration requiring repair.
Who cannot join
- Diabetes mellitus
- Asplenism
- primary immune disorder
- Mechanical heart valve
- Chronic alcoholism
- Steroid use,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management
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.
Read more
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.
- Conditions
- Wound Infection Rate
- Being tested
- wound irrigation with study fluid
- Keywords
- wound irrigation, tap water irrigation, wound infection, wound irrigation solution
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound irrigation with study fluidProcedure or surgery
wounds were either irrigated with sterile normal saline or tap water.
| Study group | Role | What they receive |
|---|---|---|
| wounds irrigated with sterile normal saline | Other | Patients in this arm had their wounds irrigated with sterile normal saline Receives: Procedure: wound irrigation with study fluid |
| wound irrigation with tap water | Other | Patients in the arm had their wounds irrigated with tap water Receives: Procedure: wound irrigation with study fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (1)
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startJun 1994
- Primary completionJun 1996
- Study completionJun 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Infection RateStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564342
- Sponsor's protocol ID
- M1272
- Status last verified
- Mar 2012
- First submitted
- 22 Mar 2012
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management
- ClinicalTrials.gov ID
- NCT01564342
- Acronym / sponsor ID
- M1272
- Conditions
- Wound Infection Rate
- Keywords
- wound irrigation, tap water irrigation, wound infection, wound irrigation solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 1994
- Primary completion
- Jun 1996 (actual)
- Study completion
- Jun 1996 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wounds irrigated with sterile normal saline | Other | Procedure: wound irrigation with study fluidPatients in this arm had their wounds irrigated with sterile normal saline |
| wound irrigation with tap water | Other | Procedure: wound irrigation with study fluidPatients in the arm had their wounds irrigated with tap water |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 1-year of age, who presented to the ED with an uncomplicated soft-tissue laceration requiring repair.
Key exclusion criteria (11 listed)
- Diabetes mellitus
- Asplenism
- primary immune disorder
- Mechanical heart valve
- Chronic alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wound irrigation with study fluidwounds were either irrigated with sterile normal saline or tap water. | Procedure or surgery | wound irrigation with tap water, wounds irrigated with sterile normal saline |
Primary outcome
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
1 secondary outcome
wound infection manifest at 30 days
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wound irrigation with study fluid in people with Wound Infection Rate, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Infection at 48 hours (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2012.