Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235456
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2005-10-06
Brief Title:
Supplemental Oxygen Reduces Surgical Infection
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Supplemental Perioperative Oxygen Reduces the Risk of Surgical Wound Infection A Randomized Double-blind Trial
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n300 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 244 of patients receiving 30 oxygen but only 149 of those receiving 80 oxygen P0039 According to logistic regression the relative risk of infection in patients given supplemental oxygen was 046 P0035 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None