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

NCT ID: NCT02649543

Last Updated: 2016-01-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-12-31

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.

Conditions

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Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Primary Closure

Primary Closure is made after surgery.

Group Type ACTIVE_COMPARATOR

Primary Closure

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Delayed Primary Closure

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Vacuum Assisted Closure

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eduardo Flores Villalba

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Flores Villalba

Associated investigator

Responsibility Role SPONSOR_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

Site Status

Countries

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Mexico

Other Identifiers

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ACAB-01

Identifier Type: -

Identifier Source: org_study_id

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