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

NCT02649543 | Completed DMC

• 1 other identifier: ACAB-01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Surgical Wound Infection; Negative-Pressure Wound Therapy; Wound Closure Techniques; Laparotomy.; Abdominal Wound Closure Techniques

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Primary Closure

ACTIVE COMPARATOR

Primary Closure is made after surgery.

Procedure: Primary Closure

Delayed Primary Closure

ACTIVE COMPARATOR

Delayed Primary Closure is made after at least 7 days.

Procedure: Delayed Primary Closure

Vacuum Assisted Closure

ACTIVE COMPARATOR

Vacuum Assisted Device is used in the wound.

Procedure: Vacuum Assisted Closure

Interventions

Primary Closure 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.

Primary Closure

Vacuum Assisted Closure 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.

Vacuum Assisted Closure

Delayed Primary Closure 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.

Delayed Primary Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laparotomy wound classified as class III or IV according to CDC's Criteria for Defining a Surgical Site Infection.

You may not qualify if:

• Patient refusal to participate in the trial

Sponsors & Collaborators

• Eduardo Flores Villalba: lead

Study Sites (1)

Escuela Nacional de Medicina, Tecnologico de Monterrey

Monterrey, Nuevo León, 76140, Mexico

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Gerardo Lozano Balderas, MD

  Escuela Nacional de Medicina, Tecnologico de Monterrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated investigator

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: January 7, 2016
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 7, 2016

Record last verified: 2016-01

Locations

ME (1)