ClinicalTrials.Veeva

Menu

The Irrigation Or No Irrigation In Simple Lacerations Trials (ION-SiLac)

U

Université de Sherbrooke

Status

Unknown

Conditions

Infection
Laceration - Injury

Treatments

Procedure: No irrigation
Procedure: Irrigation

Study type

Interventional

Funder types

Other

Identifiers

NCT02976480
2016-025

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,000 participants in 2 patient groups

Irrigation
Active Comparator group
Description:
The subjects randomized to this group will have their simple lacerations irrigated with a normal saline solution.
Treatment:
Procedure: Irrigation
No Irrigation
Experimental group
Description:
The subjects randomized to this group will not have their simple lacerations directly irrigated with a normal saline solution.
Treatment:
Procedure: No irrigation

Trial contacts and locations

1

Loading...

Central trial contact

Julien Bouchard, MD, CCFP(EM)

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems