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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Surgical Site Infection Rate Between Primary, Delayed Primary and Vacuum Assisted Closures. A Prospective Randomized Study.

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Procedure: Primary Closure
* Procedure: Vacuum Assisted Closure
* Procedure: Delayed Primary Closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Primary Closure<br>Primary Closure is made after surgery. | Procedure: Primary Closure<br>* A double antibiotic scheme with a cephalosporin and metronidazole is used as prophylaxis, and the fascia was closed with a continuous Polyglycolic Acid 0 suture. Subcutaneous tissue was approximated with Polyglycolic Acid 3-0, and the skin is sutured using Polypropylene 2-0.<br>|
| Active Comparator: Delayed Primary Closure<br>Delayed Primary Closure is made after at least 7 days. | Procedure: Delayed Primary Closure<br>* A double antibiotic scheme with a cephalosporin and metronidazole is used as prophylaxis, and the fascia was closed with a continuous Polyglycolic Acid 0 suture. The wound is left open for at least 7 days, after which closure with Polypropylene 2-0 takes place if considered suitable by a board certified surgeon.<br>|
| Active Comparator: Vacuum Assisted Closure<br>Vacuum Assisted Device is used in the wound. | Procedure: Vacuum Assisted Closure<br>* A double antibiotic scheme with a cephalosporin and metronidazole is used as prophylaxis, and the fascia is closed with a continuous Polyglycolic Acid 0 suture. The VAC® system is then used, with change of dressings every 48 hrs. The wound is closed using Polypropylene 2-0 only after healthy granulation tissue and no signs of infection are present.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Surgical Wound Infection with each Wound Closure Technique | Presence of infection was determined by a certified board physician according to CDC's Criteria for Defining a Surgical Site Infection. | Two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Wound Infection, Negative-Pressure Wound Therapy, Wound Closure Techniques, Laparotomy., Abdominal Wound Closure Techniques