Comparison of Surgical Site Infection Rate Between Primary, Delayed Primary and Vacuum Assisted Closures. A Prospective Randomized Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 81
- Locations
- 2
- Primary Endpoint
- Incidence of Surgical Wound Infection with each Wound Closure Technique
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Incidence of Surgical Wound Infection with each Wound Closure Technique
Time Frame: Two months
Presence of infection was determined by a certified board physician according to CDC's Criteria for Defining a Surgical Site Infection.
Secondary Outcomes
No secondary outcomes reported
Investigators
Eduardo Flores Villalba
Associated investigator
Tecnologico de Monterrey