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Comparison of Cyanoacrylate Tissue Adhesive and Suture for Closure of Cardiac Device Pockets

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00674128
First received: May 5, 2008
Last updated: December 1, 2010
Last verified: December 2010
History of Changes
Results First Received: October 5, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cardiovascular Disease
Interventions: Device: Cyanoacrylate tissue adhesive (Dermabond)
Device: Polyglactin 910 suture (Vicryl)

  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
Patients were recruited sequentially at a tertiary care medical center between 2 June 2008 and 19 February 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
33 patients did not meet inclusion criteria. 16 eligible patients did not consent. 103 patients were eligible and consented. 55 were assigned to Adhesive and 48 to Suture. The procedure was aborted for 5 patients in the Adhesive group and 4 patients in the Suture group.

Reporting Groups
  Description
Adhesive Cyanoacrylate tissue adhesive.
Suture Polyglactin 910 suture.

Participant Flow:   Overall Study
    Adhesive     Suture  
STARTED     50     44  
COMPLETED     25     21  
NOT COMPLETED     25     23  
Withdrawal by Subject                 25                 23  



  Baseline Characteristics
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Reporting Groups
  Description
Adhesive Cyanoacrylate tissue adhesive.
Suture Polyglactin 910 suture.
Total Total of all reporting groups

Baseline Measures
    Adhesive     Suture     Total  
Number of Participants  
[units: participants]
 		  50     44     94  
Age  
[units: years]
Mean ± Standard Deviation 		  77  ± 10     77.6  ± 9.2     77  ± 10  
Gender  
[units: participants]
 		     
Female     16     13     29  
Male     34     31     65  



  Outcome Measures

1.  Primary:   Reported Here Are the Number of Participants With Devices That Developed Infection   [ Time Frame: Within 3 months after surgery. ]
  Show Outcome Measure 1


  Serious Adverse Events
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Time Frame 3 months
Additional Description No adverse event data were collected other than infection.

Reporting Groups
  Description
Adhesive Cyanoacrylate tissue adhesive.
Suture Polyglactin 910 suture

Serious Adverse Events
    Adhesive     Suture  
Total, serious adverse events      
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)  




  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
No text entered.  


Results Point of Contact:  
Name/Title: Gregory Altemose MD
Organization: Mayo Clinic
phone: 480-301-8000
e-mail: altemose.gregory@mayo.edu


No publications provided


Responsible Party: Gregory Altemose, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00674128     History of Changes
Other Study ID Numbers: 07-001566
Study First Received: May 5, 2008
Results First Received: October 5, 2010
Last Updated: December 1, 2010
Health Authority: United States: Institutional Review Board