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
  Purpose

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


Condition Intervention Phase
Cardiac Surgery
Device: conventional bandage
Device: warming bandage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: The Influence of a Warmed Surgical Bandage System on Subcutaneous Tiisue Oxygen Tension After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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.


Enrollment: 3
Study Start Date: November 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545506

Locations
Austria
Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Outcomes Research Consortium
Investigators
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
  More Information

No publications provided

Responsible Party: Edith Fleischmann MD, Dep. Anesthesiology and Intensiv Care
ClinicalTrials.gov Identifier: NCT00545506     History of Changes
Other Study ID Numbers: 1.0
Study First Received: October 16, 2007
Results First Received: July 22, 2010
Last Updated: August 30, 2010
Health Authority: Austria: Agency for Health and Food Safety

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

ClinicalTrials.gov processed this record on April 17, 2014