Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples

This study has been terminated.
(Poor enrollment, much data was missing as patients were lost to follow up)
Sponsor:
Information provided by (Responsible Party):
Dawn Tasillo, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00524511
First received: August 31, 2007
Last updated: January 24, 2013
Last verified: January 2013
Results First Received: October 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cesarean Section
Interventions: Device: Surgical skin staples
Device: Dermabond

  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
September 4, 2007-July 9, 2010 Recruitment occured in the medical clinics and Labor and Delivery unit of an academic medical center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study design dictates that patients be enrolled upon admission to Labor and Delivery. Subsequently, patients who did not deliver by cesarean delivery would be excluded

Reporting Groups
  Description
Group Receiving Alternative Skin Closure Method (Dermabond) Women receiving Dermabond for skin closure
Group Receiving Standard Skin Closure Method (Surgical Staples Women receiving standard surgical skin staples

Participant Flow:   Overall Study
    Group Receiving Alternative Skin Closure Method (Dermabond)     Group Receiving Standard Skin Closure Method (Surgical Staples  
STARTED     68     68  
COMPLETED     64     61  
NOT COMPLETED     4     7  



  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
Group Receiving Alternative Skin Closure Method (Dermabond) Women receiving Dermabond for skin closure
Group Receiving Standard Skin Closure Method (Surgical Staples Women receiving standard surgical skin staples
Total Total of all reporting groups

Baseline Measures
    Group Receiving Alternative Skin Closure Method (Dermabond)     Group Receiving Standard Skin Closure Method (Surgical Staples     Total  
Number of Participants  
[units: participants]
  68     68     136  
Age  
[units: Participants]
     
<=18 years     1     0     1  
Between 18 and 65 years     67     68     135  
>=65 years     0     0     0  
Gender  
[units: Participants]
     
Female     68     68     136  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Wound Complication Rate   [ Time Frame: within six weeks of study intervention ]

2.  Secondary:   Patient Satisfaction of Cosmesis of Surgical Wound   [ Time Frame: before hospital discharge after surgery ]


  Serious Adverse Events


  Other Adverse Events


  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: Dawn Tasillo, MD
Organization: UMass Memorial Medical Center
phone: 5083346255
e-mail: tasillod@ummhc.org


No publications provided


Responsible Party: Dawn Tasillo, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00524511     History of Changes
Other Study ID Numbers: 12462
Study First Received: August 31, 2007
Results First Received: October 24, 2012
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board