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Supplemental Postoperative Oxygen and Wound Infection in Morbidly Obese Patients

NCT00315822 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2017-04-06

Study results available
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Summary

The investigators propose to test the hypothesis that the incidence of major complications related to infection or inadequate healing is reduced in morbidly obese patients given 80% inspired oxygen during, and for 12-18 hours after, surgery compared with patients given 80% oxygen only during surgery. The primary outcome will be a composite of major complications plausibly related to infection or healing.

Conditions

  • Surgical Wound Infection

Interventions

OTHER

80% oxygen

Supplemental oxygen will be administered during surgery

OTHER

30% oxygen

Subjects undergoing surgery will receive routine administration of oxygen

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

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

  • Anupama Wadhwa, M.D. · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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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 NCT00315822 on ClinicalTrials.gov