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

NCT02649543 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2016-01-07

No results posted yet for this study

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.

Conditions

  • Surgical Wound Infection

Interventions

PROCEDURE

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.

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.

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.

Sponsors & Collaborators

  • Eduardo Flores Villalba

    lead OTHER

Principal Investigators

  • Gerardo Lozano Balderas, MD · Escuela Nacional de Medicina, Tecnologico de Monterrey

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02649543 on ClinicalTrials.gov