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Trial record 4 of 7 for:    "Gigantomastia"

Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures

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ClinicalTrials.gov Identifier: NCT00558246
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : July 19, 2012
Last Update Posted : July 19, 2012
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Macromastia
Interventions: Device: Dermabond Protape (Prineo)
Device: Suture

  Participant Flow

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 genreal popluation of those undergoing elective, bilateral breast surgery.

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
Prineo and Suture On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.

Participant Flow:   Overall Study
    Prineo and Suture
STARTED   79 
COMPLETED   79 
NOT COMPLETED   0 



  Baseline Characteristics

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
Prineo and Suture On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.

Baseline Measures
   Prineo and Suture 
Overall Participants Analyzed 
[Units: Participants]
 79 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   78 
>=65 years   1 
Gender 
[Units: Participants]
 
Female   79 
Male   0 
Region of Enrollment 
[Units: Participants]
 
Belgium   10 
Germany   47 
United Kingdom   6 
Sweden   16 


  Outcome Measures

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 ]

2.  Secondary:   Time (Minutes) 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 months ]


  Serious Adverse Events


  Other Adverse Events


  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
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

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: Phyllis Britnell
Organization: Ethicon
phone: 1 908 218-3060
e-mail: pbritnel@its.jnj.com



Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00558246     History of Changes
Other Study ID Numbers: 07CS003
First Submitted: November 9, 2007
First Posted: November 14, 2007
Results First Submitted: June 13, 2012
Results First Posted: July 19, 2012
Last Update Posted: July 19, 2012