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

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ClinicalTrials.gov Identifier: NCT02976480
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : January 27, 2017
Sponsor:
Collaborator:
Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean
Information provided by (Responsible Party):
Julien Bouchard, Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Laceration - Injury Infection Procedure: Irrigation Procedure: No irrigation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Irrigation Or No Irrigation In Simple Lacerations Trials
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Active Comparator: Irrigation
The subjects randomized to this group will have their simple lacerations irrigated with a normal saline solution.
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.

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




Primary Outcome Measures :
  1. Laceration infection following repair [ Time Frame: At 30 days post-repair ]

    The primary outcome measured will be the 30-day post-repair infection rate in both study groups.

    At 30 days post-repair, patients will be contacted by phone by a trained nurse. A standardized form will be used to collect relevant information. Patients will be asked whether they consulted a physician for a wound infection, and if antibiotics or drainage was required. An infected wound is defined as one requiring either drainage or antibiotic treatment by the assessing physician.

    The regional Medical Electronic Record will be reviewed for patients that were lost at follow up. Records of subsequent visits for wound infection will be looked for at 30 days post-repair.



Secondary Outcome Measures :
  1. Laceration infections following repair [ Time Frame: At 5 to 10 days post-repair ]

    The wounds of enrolled subjects will systematically be evaluated by a nurse between 5 to 10 days post-repair. A standardized form will be used by the nurse to identify criteria of possible wound infection (erythema, purulence, induration, fever, pain, fluctuance, dehiscence). A wound suspected to be infected by the presence of any of the previous criteria will immediately be evaluated by an emergency room physician to adjudicate on its infection status. An infected wound is defined as one requiring either drainage or antibiotic treatment based on the judgement of the physician.

    The regional Medical Electronic Record will be reviewed for patients that were lost at follow up. Records of subsequent visits for wound infection will be looked for at 30 days post-repair.


  2. Aesthetic appearance of the laceration following repair [ Time Frame: At 30 days post-repair ]

    The following question will be asked:

    "Considering the appearance and localisation of the laceration before repair, considering that complete healing of the laceration could take up to a year duration, and considering that sun exposure needs to be avoided during the healing period, are you satisfied with the appearance your laceration has today?" Yes or No.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976480


Contacts
Contact: Julien Bouchard, MD, CCFP(EM) 418-541-1000 julien.bouchard@usherbrooke.ca

Locations
Canada, Quebec
CIUSSS Saguenay-Lac-St-Jean, Hôpital de Chicoutimi Recruiting
Chicoutimi, Quebec, Canada, G7H5H6
Contact: Julien Bouchard, MD, CCFP(EM)    418-541-1000    julien.bouchard@usherbrooke.ca   
Sub-Investigator: Antoine Herman-Lemelin, MD, CCFP(EM)         
Sub-Investigator: Sébastien Lefebvre, MD, CCFP(EM)         
Sub-Investigator: Catherine Desmeules, MD         
Sub-Investigator: Jillian Follett, MD         
Sub-Investigator: Alexandre Sauvé, MD         
Sub-Investigator: Laurence Tremblay, MD         
Sponsors and Collaborators
Université de Sherbrooke
Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean
Investigators
Principal Investigator: Julien Bouchard, MD, CCFP(EM) Université de Sherbrooke

Publications:

Responsible Party: Julien Bouchard, MD, CCFP(EM), Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02976480     History of Changes
Other Study ID Numbers: 2016-025
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Julien Bouchard, Université de Sherbrooke:
Irrigation

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries