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Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure

This study has been completed.
Information provided by (Responsible Party):
Ethicon, Inc. Identifier:
First received: October 17, 2007
Last updated: August 2, 2013
Last verified: August 2013
Results First Received: March 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lacerations
Interventions: Device: cyanoacrylate with pressure sensitive mesh
Device: cyanoacrylate

  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
Study subjects were recruited from the general population ≥1 year of age who were treated in an Emergency Department/Urgent Care Setting.

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

Reporting Groups
Dermabond Protape (Prineo) DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
Dermabond HVD DERMABOND HVD: Comparator tissue adhesive for topical application.

Participant Flow:   Overall Study
    Dermabond Protape (Prineo)     Dermabond HVD  
STARTED     143     73  
COMPLETED     119     59  
NOT COMPLETED     24     14  

  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
Dermabond Protape (Prineo) DERMABOND PROTAPE (Prineo) Tissue adhesive for Topical Application
Dermabond HVD DERMABOND HVD: Comparator Tissue Adhesive for Topical Application
Total Total of all reporting groups

Baseline Measures
    Dermabond Protape (Prineo)     Dermabond HVD     Total  
Number of Participants  
[units: participants]
  143     73     216  
[units: participants]
<=18 years     52     30     82  
Between 18 and 65 years     89     39     128  
>=65 years     2     4     6  
[units: years]
Mean ± Standard Deviation
  25.0  ± 18.4     25.7  ± 19.8     25.2  ± 18.9  
[units: participants]
Female     52     26     78  
Male     91     47     138  
Region of Enrollment  
[units: Participants]
United States     143     73     216  

  Outcome Measures
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1.  Primary:   The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure.   [ Time Frame: 14 days (±2 days) ]

2.  Secondary:   Cosmesis   [ Time Frame: 30 days (±5 days) ]

3.  Other Pre-specified:   The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30   [ Time Frame: Through Day 30 ]

4.  Other Pre-specified:   The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30   [ Time Frame: At Day 14 and Day 30 ]

5.  Other Pre-specified:   Incidence of Skin Blistering at Day 14   [ Time Frame: Day 14 ]

6.  Other Pre-specified:   Incidence of Any Other Anticipated or Unanticipated Adverse Events   [ Time Frame: Day 30 ]

  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
The percentages of participants who withdrew prematurely from the study from each group could represent a possible study limitation.

  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, Clinical Research Manager
Organization: Ethicon, Inc.
phone: 908 218 2877

No publications provided

Responsible Party: Ethicon, Inc. Identifier: NCT00547638     History of Changes
Other Study ID Numbers: 07CS005, IDE Number:G060268
Study First Received: October 17, 2007
Results First Received: March 1, 2013
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration