Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00557947
First received: November 9, 2007
Last updated: June 13, 2012
Last verified: June 2012
Results First Received: June 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Surgical Incisions
Interventions: Device: Suture
Device: Dermabond Protape (Prineo)

  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
Subjects were recruited from the general population undergoing elective surgical procedures for body contouring.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dermabond Protape/Suture Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.

Participant Flow:   Overall Study
    Dermabond Protape/Suture  
STARTED     83  
COMPLETED     83  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dermabond Protape/Suture Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.

Baseline Measures
    Dermabond Protape/Suture  
Number of Participants  
[units: participants]
  83  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     74  
>=65 years     9  
Gender  
[units: participants]
 
Female     77  
Male     6  
Region of Enrollment  
[units: participants]
 
Belgium     22  
Germany     36  
United Kingdom     20  
Sweden     5  



  Outcome Measures
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1.  Primary:   Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.   [ Time Frame: 12-25 days post-operation ]

2.  Secondary:   Time Required to Close the Final Skin Layer   [ Time Frame: Intraoperative ]

3.  Secondary:   Cosmetic Outcome   [ Time Frame: 90 days post-procedure ]

4.  Secondary:   Cosmetic Outcome   [ Time Frame: 6 months ]

5.  Secondary:   Cosmetic Outcome   [ Time Frame: 12 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Limitations of this study include the fact that the patient served as her own control. Additionally, as in many device studies, because of the obvious difference in the investigated and the control devices, blinding was limited.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John Lombard
Organization: Ethicon Inc
phone: 908-218-2877
e-mail: Jlombar8@its.jnj.com


No publications provided


Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00557947     History of Changes
Other Study ID Numbers: 06CS005
Study First Received: November 9, 2007
Results First Received: June 13, 2012
Last Updated: June 13, 2012
Health Authority: Germany: Ethics Commission
Belgium: Institutional Review Board
United Kingdom: Research Ethics Committee
Sweden: Institutional Review Board