Supplemental Oxygen Reduces Surgical Infection

This study has been completed.
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00235456
First received: October 6, 2005
Last updated: June 20, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention
Wound Infection
Procedure: Perioperative supplemental oxygen
Procedure: Standard oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Supplemental Perioperative Oxygen Reduces the Risk of Surgical Wound Infection: A Randomized, Double-blind Trial

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Incisional Surgical Wound Infection [ Time Frame: 0 to 14 days after surgery ] [ Designated as safety issue: No ]
    Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.


Secondary Outcome Measures:
  • Return of Bowel Function [ Time Frame: time to event after surgery ] [ Designated as safety issue: No ]
    Time to return of bowel function, measured in days.

  • Return to Ambulation [ Time Frame: time to event after surgery ] [ Designated as safety issue: No ]
    time to return to ambulation after surgery, measured in days

  • First Solid Food Intake [ Time Frame: time to event after surgery ] [ Designated as safety issue: No ]
    Time to restarting feeding after surgery, measured in days.

  • Staples Removed [ Time Frame: time to event after surgery ] [ Designated as safety issue: No ]
    Time to staples removed, measured in days

  • Hospital Length of Stay [ Time Frame: time to hospital discharge after surgery ] [ Designated as safety issue: No ]
    The number of days patient stayed in the hospital after surgery.


Enrollment: 300
Study Start Date: March 2003
Study Completion Date: January 2005
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 80% perioperative oxygen
Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Procedure: Perioperative supplemental oxygen
Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Placebo Comparator: 30% perioperative oxygen
Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Procedure: Standard oxygen
Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective colorectal resection,
  • Patients having abdominal-peritoneal reconstructions were included, but not those scheduled for minor colon surgery (e.g., polypectomy, isolated colostomy) or laparoscopic surgery.

Exclusion Criteria:

  • Exclusion criteria included expected surgery time of less than one hour, fever or existing signs of infection, diabetes mellitus (type I or II), HIV infection, weight loss exceeding 20% in the previous three months, serum albumin concentration < 30 g/L, and a leukocyte count <2500 cells/ml.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00235456

Locations
Spain
Hospital Clínico Universitario
Valencia, Spain
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Director: F. Javier Belda, MD, PhD Hospital Clínico Universitario de Valencia
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00235456     History of Changes
Other Study ID Numbers: RETIQ 
Study First Received: October 6, 2005
Results First Received: June 20, 2016
Last Updated: June 20, 2016
Health Authority: Spain: Ministry of Health

Keywords provided by The Cleveland Clinic:
oxygen
surgical complications
colo-rectal resections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anesthetics
Anti-Infective Agents
Antitubercular Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016