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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02649543
Other study ID # ACAB-01
Secondary ID
Status Completed
Phase N/A
First received November 25, 2015
Last updated January 6, 2016
Start date January 2012
Est. completion date December 2012

Study information

Verified date January 2016
Source Tecnologico de Monterrey
Contact n/a
Is FDA regulated No
Health authority Mexico: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

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.
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.

Locations

Country Name City State
Mexico Escuela Nacional de Medicina, Tecnologico de Monterrey Monterrey Nuevo Leon

Sponsors (1)

Lead Sponsor Collaborator
Eduardo Flores Villalba

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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