Supplemental Oxygen Reduces Surgical Infection

• 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: The Cleveland Clinic
• Information provided by (Responsible Party): d sessler, The Cleveland Clinic

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

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 of Results:

Belda FJ, Aguilera L, García de la Asunción J, Alberti J, Vicente R, Ferrándiz L, Rodríguez R, Company R, Sessler DI, Aguilar G, Botello SG, Ortí 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. Erratum in: JAMA. 2005 Dec 21;294(23):2973.

• Responsible Party: d sessler, Professor & Chair, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00235456
• Other Study ID Numbers: RETIQ
• First Posted: October 10, 2005
• 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:

Infections; Communicable Diseases; Wound Infection; Disease Attributes; Pathologic Processes