Back to results

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

Primary Purpose

Surgical Wound Infection

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Primary Closure

Vacuum Assisted Closure

Delayed Primary Closure

About this trial

This is an interventional prevention trial for Surgical Wound Infection focused on measuring Surgical Wound Infection, Negative-Pressure Wound Therapy, Wound Closure Techniques, Laparotomy., Abdominal Wound Closure Techniques

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Escuela Nacional de Medicina, Tecnologico de Monterrey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Primary Closure

Delayed Primary Closure

Vacuum Assisted Closure

Arm Description

Primary Closure is made after surgery.

Delayed Primary Closure is made after at least 7 days.

Vacuum Assisted Device is used in the wound.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02649543

First Posted

November 25, 2015

Last Updated

January 6, 2016

Sponsor

Eduardo Flores Villalba

1. Study Identification

Unique Protocol Identification Number

NCT02649543

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Eduardo Flores Villalba

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Wound Infection

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Primary Closure

Arm Type

Active Comparator

Arm Description

Primary Closure is made after surgery.

Arm Title

Delayed Primary Closure

Arm Type

Active Comparator

Arm Description

Delayed Primary Closure is made after at least 7 days.

Arm Title

Vacuum Assisted Closure

Arm Type

Active Comparator

Arm Description

Vacuum Assisted Device is used in the wound.

Intervention Type

Procedure

Intervention Name(s)

Primary Closure

Intervention Description

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

Intervention Name(s)

Vacuum Assisted Closure

Intervention Description

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

Intervention Name(s)

Delayed Primary Closure

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of Surgical Wound Infection with each Wound Closure Technique

Description

Presence of infection was determined by a certified board physician according to CDC's Criteria for Defining a Surgical Site Infection.

Time Frame

Two months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerardo Lozano Balderas, MD

Organizational Affiliation

Escuela Nacional de Medicina, Tecnologico de Monterrey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Escuela Nacional de Medicina, Tecnologico de Monterrey

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

76140

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs