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Supplemental Postoperative Oxygen and Wound Infection in Morbidly Obese Patients

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ClinicalTrials.gov Identifier: NCT00315822
Recruitment Status : Terminated (Study was terminated due to futility)
First Posted : April 19, 2006
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Information provided by (Responsible Party):
The Cleveland Clinic

Brief 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.

Condition or disease Intervention/treatment
Surgical Wound Infection Other: 80% oxygen Other: 30% oxygen

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Supplemental Postoperative Oxygen & Wound Infection in Morbidly Obese Patients
Study Start Date : May 2006
Primary Completion Date : December 2008
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 30% oxygen
Subjects undergoing surgery will receive routine administration of oxygen
Other: 30% oxygen
Subjects undergoing surgery will receive routine administration of oxygen
Active Comparator: 80% oxygen
Subject undergoing surgery will receive supplemental oxygen
Other: 80% oxygen
Supplemental oxygen will be administered during surgery

Primary Outcome Measures :
  1. Proportion of Patients With Collapsed Composite Complications [ Time Frame: 60 days after surgery ]
    Proportion of patients with the collapsed composite complications, including surgical wound infection, anastomotic leak, intra-abdominal abscess, peritonitis without leak, sepsis, wound dehiscence, intestinal obstruction, bleeding, and death during 60 days after surgery

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with a BMI > 35 kg/m2 undergoing open or laparoscopic gastric bypass

Exclusion Criteria:

  • Surgeon does not anticipate primary wound closure
  • History of fever or infection within 24 hours of surgery
  • History of susceptibility to malignant hyperthermia
  • Current heart or lung disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315822

United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Study Director: Daniel I Sessler, M.D. The Cleveland Clinic
Principal Investigator: Anupama Wadhwa, M.D. University of Louisville

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00315822     History of Changes
Other Study ID Numbers: O-O
First Posted: April 19, 2006    Key Record Dates
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017
Last Verified: February 2017

Keywords provided by The Cleveland Clinic:

Additional relevant MeSH terms:
Communicable Diseases
Wounds and Injuries
Wound Infection
Surgical Wound
Surgical Wound Infection
Postoperative Complications
Pathologic Processes