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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00547638
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
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Reporting Groups
  Description
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
  Description
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 
Overall Participants Analyzed 
[Units: Participants]
 143   73   216 
Age 
[Units: Participants]
     
<=18 years   52   30   82 
Between 18 and 65 years   89   39   128 
>=65 years   2   4   6 
Age 
[Units: Years]
Mean (Standard Deviation)
 25.0  (18.4)   25.7  (19.8)   25.2  (18.9) 
Gender 
[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
e-mail: jlombar8@its.jnj.com



Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00547638     History of Changes
Other Study ID Numbers: 07CS005
IDE Number:G060268 ( Other Identifier: FDA )
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