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The Irrigation or No Irrigation in Simple Lacerations Trials

NCT02976480 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-02-25

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean

    collaborator OTHER

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Julien Bouchard, MD, CCFP(EM) · Université de Sherbrooke

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2025-02-28
Completion
2025-02-22

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02976480 on ClinicalTrials.gov