Comparison of Surgical Site Infection Rate Between Primary, Delayed Primary and Vacuum Assisted Closures.

Not Applicable

Completed

• Conditions: Surgical Wound Infection
• Interventions: Procedure: Primary Closure; Procedure: Delayed Primary Closure; Procedure: Vacuum Assisted Closure

• Registration Number: NCT02649543
• Lead Sponsor: Eduardo Flores Villalba

Brief Summary

The objective of the study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.

Detailed Description

The objective of this study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.

Social, demographic, surgical, postsurgical and medical variables were registered. A descriptive analysis expressed as total and percentages, medians and interquartile ranges. Comparison between groups was made using the Kruskal-Wallis, U-Mann Whitney or Chi-squared as appropriate. A p value of less than 0.05 was considered significant.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2015-11-25
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-06
• Last Update Submitted: 2016-01-06
• Study First Posted: 2016-01-07
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Laparotomy wound classified as class III or IV according to CDC's Criteria for Defining a Surgical Site Infection.

Exclusion Criteria

• Patient refusal to participate in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Closure	Primary Closure	Primary Closure is made after surgery.
Delayed Primary Closure	Delayed Primary Closure	Delayed Primary Closure is made after at least 7 days.
Vacuum Assisted Closure	Vacuum Assisted Closure	Vacuum Assisted Device is used in the wound.

Primary Outcome Measures

Name	Time	Method
Incidence of Surgical Wound Infection with each Wound Closure Technique	Two months	Presence of infection was determined by a certified board physician according to CDC's Criteria for Defining a Surgical Site Infection.

Trial Locations

Locations (1)

Escuela Nacional de Medicina, Tecnologico de Monterrey; 🇲🇽 Monterrey, Nuevo Leon, Mexico