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Supplemental Oxygen Reduces Surgical Infection

Primary Purpose

Wound Infection

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Perioperative supplemental oxygen
Standard oxygen
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Infection focused on measuring oxygen, surgical complications, colo-rectal resections

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clínico Universitario

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

80% perioperative oxygen

30% perioperative oxygen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incisional Surgical Wound Infection
Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.

Secondary Outcome Measures

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

Full Information

First Posted
October 6, 2005
Last Updated
December 18, 2016
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00235456
Brief Title
Supplemental Oxygen Reduces Surgical Infection
Official Title
Supplemental Perioperative Oxygen Reduces the Risk of Surgical Wound Infection: A Randomized, Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
oxygen, surgical complications, colo-rectal resections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
80% perioperative oxygen
Arm Type
Active Comparator
Arm Description
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.
Arm Title
30% perioperative oxygen
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Perioperative supplemental oxygen
Intervention Description
Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Intervention Type
Procedure
Intervention Name(s)
Standard oxygen
Intervention Description
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 Measure Information:
Title
Incisional Surgical Wound Infection
Description
Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.
Time Frame
0 to 14 days after surgery
Secondary Outcome Measure Information:
Title
Return of Bowel Function
Description
Time to return of bowel function, measured in days.
Time Frame
time to event after surgery to discharge from hospital
Title
Return to Ambulation
Description
time to return to ambulation after surgery, measured in days
Time Frame
time to event after surgery
Title
First Solid Food Intake
Description
Time to restarting feeding after surgery, measured in days.
Time Frame
time to event after surgery
Title
Staples Removed
Description
Time to staples removed, measured in days
Time Frame
time to event after surgery
Title
Hospital Length of Stay
Description
The number of days patient stayed in the hospital after surgery.
Time Frame
time to hospital discharge after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F. Javier Belda, MD, PhD
Organizational Affiliation
Hospital Clínico Universitario de Valencia
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clínico Universitario
City
Valencia
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16249417
Citation
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.
Results Reference
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Supplemental Oxygen Reduces Surgical Infection

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