Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01298167
First received: February 15, 2011
Last updated: October 10, 2012
Last verified: October 2012
Results First Received: September 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma
Intervention: Device: Cyanoacrylate tissue glue versus Fast absorbing gut

  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
No text entered.

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
Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.

Participant Flow:   Overall Study
    Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound     FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound  
STARTED     6     8  
COMPLETED     5     8  
NOT COMPLETED     1     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
Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
Total Total of all reporting groups

Baseline Measures
    Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound     FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound     Total  
Number of Participants  
[units: participants]
  6     8     14  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     5     7  
>=65 years     4     3     7  
Gender  
[units: participants]
     
Female     2     2     4  
Male     4     6     10  



  Outcome Measures

1.  Primary:   Visual Analog Scale (VAS)   [ Time Frame: 3 months ]


  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
None.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Leffell, MD
Organization: Yale University
phone: 203 785 7999
e-mail: david.leffell@yale.edu


No publications provided


Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01298167     History of Changes
Other Study ID Numbers: 1101007845
Study First Received: February 15, 2011
Results First Received: September 10, 2012
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board