Supplemental Postoperative Oxygen and Wound Infection in Morbidly Obese Patients

This study has been terminated.
(Study was terminated due to futility)
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00315822
First received: April 17, 2006
Last updated: February 5, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Surgical Wound Infection
Other: oxygen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Supplemental Postoperative Oxygen & Wound Infection in Morbidly Obese Patients

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • The incidence of postoperative wound infection and duration of hospitalization. [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stroke [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
  • Pulmonary emboli [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
  • Pulmonary edema [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
  • Ventricular arrhythmias [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
  • Renal failure [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
  • Pulmonary edema and congestive heart failure [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
  • Pneumonia [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
  • Paralytic ileus [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
  • Pneumothorax [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
  • Minor cardiac arrhythmias [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
  • Cystitis or urinary tract infection [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]
  • Psychosis [ Time Frame: 60 days after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 1276
Study Start Date: May 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Subjects undergoing surgery will receive routine administration of oxygen
Active Comparator: 2
Subject undergoing surgery will receive supplemental oxygen
Other: oxygen
Supplemental oxygen will be administered during surgery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315822

Locations
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
Outcomes Research Consortium
Investigators
Study Director: Daniel I Sessler, M.D. The Cleveland Clinic
Principal Investigator: Anupama Wadhwa, M.D. University of Louisville
  More Information

No publications provided

Responsible Party: Daniel Sessler, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00315822     History of Changes
Other Study ID Numbers: O-O
Study First Received: April 17, 2006
Last Updated: February 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
Surgery
colon

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

ClinicalTrials.gov processed this record on September 18, 2014