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

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

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 ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

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
None.

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