Supplemental Postoperative Oxygen and Wound Infection in Morbidly Obese Patients

NCT00315822 | Terminated Results

• 1 other identifier: O-O
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgical Wound Infection

Keywords

Surgery; colon

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Collapsed Composite Complications

  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

  60 days after surgery

Study Arms (2)

30% oxygen

PLACEBO COMPARATOR

Subjects undergoing surgery will receive routine administration of oxygen

Other: 30% oxygen

80% oxygen

ACTIVE COMPARATOR

Subject undergoing surgery will receive supplemental oxygen

Other: 80% oxygen

Interventions

80% oxygen OTHER

Supplemental oxygen will be administered during surgery

80% oxygen

30% oxygen OTHER

Subjects undergoing surgery will receive routine administration of oxygen

30% oxygen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (2)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Results Point of Contact

• Title: Daniel Sessler, MD
• Organization: Cleveland Clinic

sessled@ccf.org

216-444-4900

Study Officials

• Daniel I Sessler, M.D.

  The Cleveland Clinic

  STUDY DIRECTOR

• Anupama Wadhwa, M.D.

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2006
• First Posted: April 19, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: April 6, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-02

Locations

US (2)