Clinical trial NCT02976480: The Irrigation or No Irrigation in Simple Lacerations Trials
Official title: The Irrigation or No Irrigation in Simple Lacerations Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laceration - Injury
Infection
Keywords: Irrigation
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean
First posted: 2016-11-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Background: Current guidelines recommend that lacerations be irrigated prior to their closure. However, there is very little data in the literature suggesting that simple laceration irrigation diminishes the subsequent rate of infection. Do patients benefit from this practice that involves additional time and costs?

Hypothesis Testing \& Procedure: The purpose of this double-blind randomized controlled non-inferiority study is to test the hypothesis that the non-irrigation of lacerations does not increase the rate of post-repair infection. Every adult patients presenting to the Chicoutimi's Hospital Emergency Department with a simple laceration will be identify by the triage nurse. Eligibility will subsequently be assessed by the emergency room physician according to the inclusion and exclusion criteria. Eligible and consenting patients will be randomized to either the irrigation or non-irrigation arm. Post-repair rate of infection and aesthetic appearance satisfaction will be reported.

Sample Size Determination: With the fairly liberal inclusion criteria, a 6% wound infection rate in the irrigation group is expected, which corresponds to the upper limit of the 2 to 6% range reported in the literature. Non-inferiority of non-irrigation would be accepted if the rate of infection in this group does not exceed by 4% the usual infection rate of 6% with irrigation, as previously stated. As such, for the study to be powered at 80% with a 95% one-sided confidence interval, a population of 874 patients would be needed to conclude that the non-irrigation is non-inferior when its infection rate does not exceed by more than 4% the infection rate of the irrigation group. In addition, to account for an attrition rate of approximately 10%, enrolment of 1000 patients is aimed.

Statistical Analysis: Statistical analysis will be done by a certified statistician. According to the distribution of our data, the Chi2 or the Fisher test will be used. A preliminary analysis of our data will be done in the Spring 2017 to assess safety of our intervention.

Plan for Missing Data: Patients that are lost at follow up will be considered as having had no infection if no record of subsequent visits for wound infection is found after consultation of the regional Electronic Medical Record.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* pregnant patients
* involving tendons, muscles, fascias, articulations
* located on the ear, nose or distal to metacarpophalangeal or metatarsophalangeal joint
* immunosuppressed (neutropenia, chronic corticotherapy, HIV, immunosuppressive therapy within 3 months)
* bite wounds
* lacerations with any loss of substance
* lacerations with foreign body
* complex lacerations (crush, stellate)
* grossly contaminated

Primary outcomes:
measure: Laceration infection following repair
timeFrame: At 30 days post-repair
Secondary outcomes:
measure: Laceration infections following repair
timeFrame: At 5 to 10 days post-repair
measure: Aesthetic appearance of the laceration following repair
timeFrame: At 30 days post-repair
Other outcomes:
Locations:
city: Chicoutimi
country: Canada
facility: CIUSSS Saguenay-Lac-St-Jean, Hôpital de Chicoutimi
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Julien Bouchard, MD, CCFP(EM)
role: PRINCIPAL_INVESTIGATOR
References:
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