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

Eduardo Flores Villalba

Status: Completed

Conditions: Surgical Wound Infection

Treatments: Procedure: Delayed Primary Closure; Procedure: Vacuum Assisted Closure; Procedure: Primary Closure

Study type: Interventional

Funder types: Other

Identifiers

NCT02649543

ACAB-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 3 patient groups

Primary Closure

Active Comparator group

Description:

Primary Closure is made after surgery.

Treatment:

Procedure: Primary Closure

Delayed Primary Closure

Active Comparator group

Description:

Delayed Primary Closure is made after at least 7 days.

Treatment:

Procedure: Delayed Primary Closure

Vacuum Assisted Closure

Active Comparator group

Description:

Vacuum Assisted Device is used in the wound.

Treatment:

Procedure: Vacuum Assisted Closure