Clinical Trial: The Irrigation Or No Irrigation In Simple Lacerations Trials

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Irrigation Or No Irrigation In Simple Lacerations Trials

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.

Detailed Summary:

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.

Statisti
Sponsor: Université de Sherbrooke

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.

• 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.

Original Secondary Outcome: Same as current

Information By: Université de Sherbrooke

Dates:
Date Received: November 3, 2016
Date Started: January 2017
Date Completion: January 2019
Last Updated: January 25, 2017
Last Verified: January 2017