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The Effects of Hypercapnia, Supplemental Oxygen, and Dexamethasone on Surgical Wound Infection

NCT00273377 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2016-06-29

No results posted yet for this study

Summary

The investigators will test the hypotheses that mild hypercapnia and supplemental oxygen reduce wound infection risk in patients undergoing colon resection. The investigators will simultaneously test the hypothesis that low-dose dexamethasone (a common treatment for postoperative nausea and vomiting) does not increase infection risk.

Conditions

  • Surgical Wound Infection
  • Surgery, Colon

Interventions

OTHER

Mild intraoperative hypercapnia (50 mmHg vs. 30 mmHg)

OTHER

Supplemental oxygen (80% vs. 30%)

DRUG

Dexamethasone

4 mg

DRUG

Placebo

placebo

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Daniel I Sessler, M.D. · The Cleveland Clinic

  • Ozan Akca, M.D. · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States
  • Austria
  • Ireland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00273377 on ClinicalTrials.gov