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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00545506
Recruitment Status : Terminated (lack of eligible patients)
First Posted : October 17, 2007
Results First Posted : September 21, 2010
Last Update Posted : September 21, 2010
Outcomes Research Consortium
Information provided by:
Medical University of Vienna

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

Condition or disease Intervention/treatment Phase
Cardiac Surgery Device: conventional bandage Device: warming bandage Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: The Influence of a Warmed Surgical Bandage System on Subcutaneous Tiisue Oxygen Tension After Cardiac Surgery
Study Start Date : November 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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.
Device: warming bandage

Primary Outcome Measures :
  1. Tissue Oxygenation Levels [ Time Frame: 2 years ]
  2. Tissue Oxygen Tension in the Sternal Wound [ Time Frame: 8 hours ]
    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.

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

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.

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 identifier (NCT number): NCT00545506

Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
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

Responsible Party: Edith Fleischmann MD, Dep. Anesthesiology and Intensiv Care Identifier: NCT00545506     History of Changes
Other Study ID Numbers: 1.0
First Posted: October 17, 2007    Key Record Dates
Results First Posted: September 21, 2010
Last Update Posted: September 21, 2010
Last Verified: August 2010

Keywords provided by Medical University of Vienna:
wound infection
tissue oxygen tension
local warming