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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 (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00315822
First received: April 17, 2006
Last updated: February 22, 2017
Last verified: February 2017
  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
Surgical Wound Infection
Other: 80% oxygen
Other: 30% oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Other
Official Title: Supplemental Postoperative Oxygen & Wound Infection in Morbidly Obese Patients

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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


Enrollment: 400
Study Start Date: May 2006
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
The Cleveland Clinic
Investigators
Study Director: Daniel I Sessler, M.D. The Cleveland Clinic
Principal Investigator: Anupama Wadhwa, M.D. University of Louisville
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00315822     History of Changes
Other Study ID Numbers: O-O
Study First Received: April 17, 2006
Results First Received: November 29, 2016
Last Updated: February 22, 2017

Keywords provided by The Cleveland Clinic:
Surgery
colon

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

ClinicalTrials.gov processed this record on April 28, 2017