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Supplemental Oxygen Reduces Surgical Infection

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ClinicalTrials.gov Identifier: NCT00235456
Recruitment Status : Completed
First Posted : October 10, 2005
Results First Posted : July 29, 2016
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
d sessler, The Cleveland Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Wound Infection Procedure: Perioperative supplemental oxygen Procedure: Standard oxygen Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Supplemental Perioperative Oxygen Reduces the Risk of Surgical Wound Infection: A Randomized, Double-blind Trial
Study Start Date : March 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Incisional Surgical Wound Infection [ Time Frame: 0 to 14 days after surgery ]
    Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.


Secondary Outcome Measures :
  1. Return of Bowel Function [ Time Frame: time to event after surgery to discharge from hospital ]
    Time to return of bowel function, measured in days.

  2. Return to Ambulation [ Time Frame: time to event after surgery ]
    time to return to ambulation after surgery, measured in days

  3. First Solid Food Intake [ Time Frame: time to event after surgery ]
    Time to restarting feeding after surgery, measured in days.

  4. Staples Removed [ Time Frame: time to event after surgery ]
    Time to staples removed, measured in days

  5. Hospital Length of Stay [ Time Frame: time to hospital discharge after surgery ]
    The number of days patient stayed in the hospital after surgery.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235456


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

Publications of Results:
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Responsible Party: d sessler, Professor & Chair, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00235456     History of Changes
Other Study ID Numbers: RETIQ
First Posted: October 10, 2005    Key Record Dates
Results First Posted: July 29, 2016
Last Update Posted: February 10, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by d sessler, The Cleveland Clinic:
oxygen
surgical complications
colo-rectal resections
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wound Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anesthetics
Anti-Infective Agents
Antitubercular Agents
Central Nervous System Depressants
Physiological Effects of Drugs