Hospital Clínico Universitario
Valencia, Spain
NCT Number: NCT00235456
Supplemental perioperative oxygen has been reported to halve or double the risk of surgical wound infection. We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery. Colorectal surgery patients (n=300) were randomly assigned to 30% or 80% FiO2 intraoperatively and 6 hours postoperatively. Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. Wound infection rates were compared with chi-square analysis. Logistic regression identified the contribution of potential confounding factors. Surgical wound infection occurred in 24.4% of patients receiving 30% oxygen, but only 14.9% of those receiving 80% oxygen (P<0.039). According to logistic regression, the relative risk of infection in patients given supplemental oxygen was 0.46 (P=0.035). Supplemental inspired oxygen reduced wound infection risk by roughly a factor of two. We thus recommend that supplemental oxygen be provided to patients undergoing colorectal surgery.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Valencia, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Time frame: 0 to 14 days after surgery
Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.
Time frame: time to event after surgery to discharge from hospital
Time to return of bowel function, measured in days.
Time frame: time to event after surgery
time to return to ambulation after surgery, measured in days
Time frame: time to event after surgery
Time to restarting feeding after surgery, measured in days.
Time frame: time to event after surgery
Time to staples removed, measured in days
Time frame: time to hospital discharge after surgery
The number of days patient stayed in the hospital after surgery.
The Cleveland Clinic
Other
Supplemental Perioperative Oxygen Reduces the Risk of Surgical Wound Infection: A Randomized, Double-blind Trial
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