Surgical Wound Infection Clinical Trial
Official title:
Comparison of Surgical Site Infection Rate Between Primary, Delayed Primary and Vacuum Assisted Closures. A Prospective Randomized Study.
Verified date | January 2016 |
Source | Tecnologico de Monterrey |
Contact | n/a |
Is FDA regulated | No |
Health authority | Mexico: Ethics Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Mexico | Escuela Nacional de Medicina, Tecnologico de Monterrey | Monterrey | Nuevo Leon |
Lead Sponsor | Collaborator |
---|---|
Eduardo Flores Villalba |
Mexico,
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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