Supplemental Oxygen Reduces Surgical Infection
Procedure: Perioperative supplemental oxygen
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Supplemental Perioperative Oxygen Reduces the Risk of Surgical Wound Infection: A Randomized, Double-Blind Trial|
- incisional surgical wound infection
- return of bowel function and ability to tolerate solid food, ambulation, suture removal, and duration of hospitalization
|Study Start Date:||March 2003|
|Study Completion Date:||January 2005|
Context: Supplemental perioperative oxygen has been variously reported to halve or double the risk of surgical wound infection.
Objective: We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery.
Design: Randomized, controlled trial. Setting: Fourteen Spanish hospitals. Patients: Three hundred patients undergoing elective colorectal surgery. Interventions: Patients were randomly assigned to either 30% or 80% FiO2 intraoperatively and for 6 hours after surgery. Anesthetic management and antibiotic administration were standardized.
Main outcome measures: Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. The wound infection rate in the 30% and 80% oxygen groups was compared with chi-square analysis. A logistic regression was used to identify the contribution of potential confounding factors.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235456
|Hospital Clínico Universitario|
|Study Director:||F. Javier Belda, MD, PhD||Hospital Clínico Universitario de Valencia|