Comparing Irrigation with No irrigation for laceration - injury
Official title: The Irrigation or No Irrigation in Simple Lacerations Trials
- 2 groups
- One site, in Chicoutimi
- Recruiting
Interventions
- Medical procedure
Irrigation
A designated unblinded medical team member (nurse, emergency room physician or resident/trainee uninvolved in that particular patient's care) will prepare the laceration for repair and perform the irrigation. Irrigation will be delivered through a 20 Gauge 1 inch long catheter mounted on a 60 millilitre syringe. The volume of normal saline used will be calculated as 60 millilitre per centimetre length of laceration for a maximum of 300 millilitre. Once completed, the treating physician will enter the room and proceed to the laceration closure with the method and equipment of his choice. Both the patient (through eye covering) and the treating physician will remain blinded to the intervention.
- Medical procedure
No irrigation
A designated unblinded medical team member (nurse, emergency room physician or resident/trainee uninvolved in that particular patient's care) will prepare the laceration for repair. The laceration will not directly be irrigated. In order to ensure blinding of the subjects, the surrounding of the wound will be irrigated with a total of 60 millilitre of normal saline delivered through a 20 Gauge 1 inch long catheter mounted on a 60 millilitre syringe. Care will be taken not to enter a margin of 5cm from the laceration edges. Once completed, the treating physician will enter the room and proceed to the laceration closure with the method and equipment of his choice. Both the patient (through eye covering) and the treating physician will remain blinded to the intervention.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
CIUSSS Saguenay-Lac-St-Jean, Hôpital de Chicoutimi
Chicoutimi, Quebec
Eligibility Criteria
See who this study is looking for13 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +age 18 or older
- +repair within 18 hours from time of injury
- +repair done by the emergency room physician or trainee
- +clean and simple lacerations (clean edge with no gross contamination, as assessed by the treating physician)
Exclusion
- −immunosuppressed (neutropenia, chronic corticotherapy, HIV, immunosuppressive therapy within 3 months)
- −involving tendons, muscles, fascias, articulations
- −located on the ear, nose or distal to metacarpophalangeal or metatarsophalangeal joint
- −bite wounds
- −lacerations with any loss of substance
- −lacerations with foreign body
- −complex lacerations (crush, stellate)
- −grossly contaminated
- −pregnant patients
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Irrigation.
Registry label: A: Irrigation
Group B receives No irrigation.
Registry label: B: No Irrigation
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,000 people.
The study is currently expected to finish around February 2025.
The main measurement is taken over: At 30 days post-repair.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Laceration infection following repair — measured over At 30 days post-repair.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT02976480 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About IrrigationProcedure
A designated unblinded medical team member (nurse, emergency room physician or resident/trainee uninvolved in that particular patient's care) will prepare the laceration for repair and perform the irrigation. Irrigation will be delivered through a 20 Gauge 1 inch long catheter mounted on a 60 millilitre syringe. The volume of normal saline used will be calculated as 60 millilitre per centimetre length of laceration for a maximum of 300 millilitre. Once completed, the treating physician will enter the room and proceed to the laceration closure with the method and equipment of his choice. Both the patient (through eye covering) and the treating physician will remain blinded to the intervention.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About No irrigationProcedure
A designated unblinded medical team member (nurse, emergency room physician or resident/trainee uninvolved in that particular patient's care) will prepare the laceration for repair. The laceration will not directly be irrigated. In order to ensure blinding of the subjects, the surrounding of the wound will be irrigated with a total of 60 millilitre of normal saline delivered through a 20 Gauge 1 inch long catheter mounted on a 60 millilitre syringe. Care will be taken not to enter a margin of 5cm from the laceration edges. Once completed, the treating physician will enter the room and proceed to the laceration closure with the method and equipment of his choice. Both the patient (through eye covering) and the treating physician will remain blinded to the intervention.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At 30 days post-repair.
The study as a whole is currently expected to finish around 2025-02-22.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Chicoutimi, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to determine whether the irrigation or non-irrigation of a simple laceration treated in the emergency department has an effect on the subsequent rate of infection.
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Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.