Recruiting

Irrigation

Sponsor:

Université de Sherbrooke

Code:

NCT02976480

Conditions

Laceration - Injury

Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Irrigation

No irrigation

Study Details

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.

Conditions

Laceration - Injury

Infection

Study ID

NCT02976480

Start date

Jan, 2017

Status verified date

Feb, 2025

Completion date

Feb 22, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Irrigation

The subjects randomized to this group will have their simple lacerations irrigated with a normal saline solution.

experimental: No Irrigation

The subjects randomized to this group will not have their simple lacerations directly irrigated with a normal saline solution.

Interventions

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.

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 measure

  • Laceration infection following repair [ Time Frame: At 30 days post-repair ]

Central Contacts and Locations

Central contacts

Julien Bouchard, MD, CCFP(EM)

418-541-1000julien.bouchard@usherbrooke.ca

Locations

CIUSSS Saguenay-Lac-St-Jean, Hôpital de Chicoutimi

Recruiting

Chicoutimi, Quebec, Canada, G7H5H6

Contacts

Julien Bouchard, MD, CCFP(EM)

418-541-1000julien.bouchard@usherbrooke.ca

More Information

Sponsor

Université de Sherbrooke

Last update posted

Feb 25, 2025

Last verified

Feb, 2025

Keywords

  • Irrigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2025-02-25.