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The Influence of a Warmed Surgical Bandage System on Subcutaneous Tissue Oxygen Tension After Cardiac Surgery

This study has been terminated.
(lack of eligible patients)
Sponsor:
Collaborator:
Outcomes Research Consortium
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00545506
First received: October 16, 2007
Last updated: August 30, 2010
Last verified: August 2010
History of Changes

October 16, 2007
August 30, 2010
November 2007
November 2009   (final data collection date for primary outcome measure)
  • Tissue Oxygenation Levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Tissue Oxygen Tension in the Sternal Wound [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Tissue oxygen tension in the wound Tissue oxygen tension will be measured with a polarographic electrode system (Licox CMP, GMS Germany), the oxygen electrode will be calibrated with room air (154 mmHg) and then positioned within the silastic tonometer that will be inserted 2 3 cm lateral to the surgical incision.
tissue oxygenation levels [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00545506 on ClinicalTrials.gov Archive Site
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The Influence of a Warmed Surgical Bandage System on Subcutaneous Tissue Oxygen Tension After Cardiac Surgery
The Influence of a Warmed Surgical Bandage System on Subcutaneous Tiisue Oxygen Tension After Cardiac Surgery

Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound infections

Wound infections are common and serious complications of anesthesia and surgery. The morbidity associated with surgical infections is considerable and includes substantial prolongation of hospitalization.

The wound infection risk in patients undergoing cardiac surgery ranges from 0.8 to 17.7% including both superficial and deep sternal infections.

Major factors influencing the incidence of surgical wound infection other than site and complexity of surgery, underlying illness, timely administration of prophylactic antibiotics, intraoperative patient temperature, hypovolemia and tissue oxygen tension. The primary determinant of tissue oxygen availability is local perfusion. Thermoregulatory status is one of the major factors influencing tissue perfusion. Local warming induces pre- capillary vasodilation and improves tissue oxygenation. Local warming of surgical wounds may provide a simple and inexpensive way to reduce perioperative wound complications. Specifically, we will test the hypothesis that Warm- Up therapy increases postoperative tissue oxygen tension in patients undergoing cardiopulmonary bypass.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Cardiac Surgery
  • Device: conventional bandage
  • Device: warming bandage
  • Active Comparator: conventional bandage
    conventional bandage on sternal wound after skin closure after cardiac surgery. conventional gauze covered with elastic adhesive (Medipore™ Dress-it) The designated bandage will be positioned in the operating room by the surgeons after the skin will be closed. The conventional elastic bandage consists of several layers of gauze covered with a special adhesive bandage
    Intervention: Device: conventional bandage
  • Active Comparator: warming bandage
    The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The surface temperature of heating card is fixed at 38°C, and heat is usually provided for two hours at a time. That is, the experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle.
    Intervention: Device: warming bandage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients ≥18 years of age scheduled for elective cardiac surgery on normothermic cardio-pulmonary bypass will be invited to participate

Exclusion Criteria:

  • Emergency surgery
  • Pre - or postoperative on intraaortic balloon pump
  • Preoperative mechanical ventilation
  • Postoperative respiratory failure
  • Postoperative extracorporal membrane oxygenation
  • Left ventricular function < 40%
  • Fever (core temperature > 38 °C) or current infection
  • No anticipated or no definitive primary closure of surgical wound.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00545506
1.0
Yes
Edith Fleischmann MD, Dep. Anesthesiology and Intensiv Care
Medical University of Vienna
Outcomes Research Consortium
Principal Investigator: Barbara Kabon, MD Medical University Vienna,Spitalgasse 23, 1090 Vienna, Austria
Principal Investigator: Helmut Hager, MD Medical University Vienna, Spitalgasse 23, 1090 Vienna, Austra
Medical University of Vienna
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP