Comparison of Surgical Site Infection Rate Between Primary, Delayed Primary and Vacuum Assisted Closures.
NCT ID: NCT02649543
Last Updated: 2016-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2012-01-31
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Primary Closure
Primary Closure is made after surgery.
Primary Closure
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.
Delayed Primary Closure
Delayed Primary Closure is made after at least 7 days.
Delayed Primary Closure
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.
Vacuum Assisted Closure
Vacuum Assisted Device is used in the wound.
Vacuum Assisted Closure
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.
Interventions
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Primary Closure
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.
Vacuum Assisted Closure
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.
Delayed Primary Closure
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Eduardo Flores Villalba
OTHER
Responsible Party
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Eduardo Flores Villalba
Associated investigator
Principal Investigators
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Gerardo Lozano Balderas, MD
Role: PRINCIPAL_INVESTIGATOR
Escuela Nacional de Medicina, Tecnologico de Monterrey
Locations
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Escuela Nacional de Medicina, Tecnologico de Monterrey
Monterrey, Nuevo León, Mexico
Countries
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Other Identifiers
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ACAB-01
Identifier Type: -
Identifier Source: org_study_id
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