CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
Perioperative supplemental oxygen +1 moreprocedure
Likely dose
80% FIO2 intraoperatively and for 6 hours after surgery (supplemental group); 30% FIO2 intraoperatively and for 6 hours after surgery (control group)AI-extracted
Key inclusion· 1
  • Elective colorectal resection
Key exclusion· 7
  • Surgery expected to last less than one hour
  • Fever or existing signs of infection
  • Diabetes mellitus (type I or II)
  • HIV infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00235456
NCT00235456N/ACompleted

Supplemental Perioperative Oxygen Reduces the Risk of Surgical Wound Infection: A Randomized, Double-blind Trial

The Cleveland Clinic·interventional·Posted Oct 10, 2005·Updated Feb 10, 2017

In Brief

A clinical study evaluating Perioperative supplemental oxygen and Standard oxygen for Wound Infection. Completed, enrolled 300 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWound Infection
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 10, 2005
Enrollment StartMar 1, 2003
Primary CompletionOct 1, 2004
Study CompletionJan 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 20.7 years ago

Interventions

Perioperative supplemental oxygenprocedure

Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.

Standard oxygenprocedure

Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.