Supplemental Oxygen Reduces Surgical Infection

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

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 Overview

• Status: Completed
• Conditions: Wound Infection
• Intervention / Treatment: Procedure: Perioperative supplemental oxygen; Procedure: Standard oxygen

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain
    • Hospital Clinico Universitario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incisional Surgical Wound Infection	Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.	0 to 14 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of Bowel Function	Time to return of bowel function, measured in days.	time to event after surgery to discharge from hospital
Return to Ambulation	time to return to ambulation after surgery, measured in days	time to event after surgery
First Solid Food Intake	Time to restarting feeding after surgery, measured in days.	time to event after surgery
Staples Removed	Time to staples removed, measured in days	time to event after surgery
Hospital Length of Stay	The number of days patient stayed in the hospital after surgery.	time to hospital discharge after surgery

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Study Director: F. Javier Belda, MD, PhD, Hospital Clínico Universitario de Valencia

Publications and helpful links

General Publications

• Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035. Erratum In: JAMA. 2005 Dec 21;294(23):2973.

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): January 1, 2005

Study Registration Dates

• First Submitted: October 6, 2005
• First Submitted That Met QC Criteria: October 6, 2005
• First Posted (Estimate): October 10, 2005

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: oxygen; surgical complications; colo-rectal resections
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Wound Infection
• Other Study ID Numbers: RETIQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO