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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
Results First Received: July 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Basic Science
Condition: Cardiac Surgery
Interventions: Device: conventional bandage
Device: warming bandage

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
research personnel will screen the patient list one day before surgery to identify eligible patients

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
none

Reporting Groups
  Description
Heart Surgery, Wound Infection, Conventional Bandage konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen warming bandage on sternal wound 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 experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle

Participant Flow:   Overall Study
    Heart Surgery, Wound Infection, Conventional Bandage     Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen  
STARTED     3     3  
COMPLETED     3     3  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Heart Surgery, Wound Infection, Conventional Bandage konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen warming bandage on sternal wound 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 experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
Total Total of all reporting groups

Baseline Measures
    Heart Surgery, Wound Infection, Conventional Bandage     Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen     Total  
Number of Participants  
[units: participants]
 		  20     20     40  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  55  ± 5     55  ± 5     55  ± 5  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     20     20     40  
Region of Enrollment  
[units: participants]
 		     
Austria     20     20     40  



  Outcome Measures

1.  Primary:   Tissue Oxygen Tension in the Sternal Wound   [ Time Frame: 8 hours ]
  Show Outcome Measure 1

2.  Primary:   Tissue Oxygenation Levels   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   11/2009   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Tissue oxygen tension maybe difficult to measure in the sternal wound  


Results Point of Contact:  
Name/Title: Helmut Hager
Organization: Dep. Anesthesia And Intensive Care
phone: +43 1 40400 4102
e-mail: helmut.hager@meduniwien.ac.at


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