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The Irrigation Or No Irrigation In Simple Lacerations Trials

2016-11-30 15:45:27 | BioPortfolio

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.

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Laceration - Injury

Intervention

Irrigation, No irrigation

Location

CIUSSS Saguenay-Lac-St-Jean, Hôpital de Chicoutimi
Chicoutimi
Quebec
Canada
G7H5H6

Status

Not yet recruiting

Source

Université de Sherbrooke

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-30T15:45:27-0500

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Medical and Biotech [MESH] Definitions

The washing of a body cavity or surface by flowing solution which is inserted and then removed. Any drug in the irrigation solution may be absorbed.

Irrigation of the nose with saline or irrigation solutions for diagnostic or therapeutic purposes. It is used to remove irritants, allergens, or microorganisms from the nose.

The washing of a body cavity or surface by flowing water or solution for therapy or diagnosis.

The routing of water to open or closed areas where it is used for agricultural purposes.

Local antibacterial that probably acts by releasing formaldehyde in aqueous solutions. It is used for irrigation of infected body cavities - bladder, peritoneum, etc. and as a spray for burns.

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