Trial Outcomes & Findings for Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery (NCT NCT01298167)

Results Overview

The Visual Analog or Analogue Scale (VAS)\* is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to their feeling. It also gives the maximum opportunity for each respondent to express a personal response style. The scale is interpreted as the greater the scale score (as the score approaches 10), the greater the cosmetic and functional outcome of the healed wound. * Aitken, R. C. B. (1969). Measurement of feelings using visual analogue scales. Proceedings of the Royal Society of Medicine. 62, 989 - 993 * Freyd, M. (1923). The graphic rating scale. Journal of Educational Psychology, 43, 83 - 102 * Hayes, M. H. S. \& D. G. Patterson (1921). Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

3 months

Results posted on

2012-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	6	8
Overall Study COMPLETED	5	8
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound n=6 Participants 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 n=8 Participants 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 n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Individuals' wounds were divided in half and then treated with both Cyanoacrylate and Fast Absorbing Gut Suture. Individuals were randomized as to which half of the wound (superior or inferior) would be treated by each of the methods.

The Visual Analog or Analogue Scale (VAS)\* is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to their feeling. It also gives the maximum opportunity for each respondent to express a personal response style. The scale is interpreted as the greater the scale score (as the score approaches 10), the greater the cosmetic and functional outcome of the healed wound. * Aitken, R. C. B. (1969). Measurement of feelings using visual analogue scales. Proceedings of the Royal Society of Medicine. 62, 989 - 993 * Freyd, M. (1923). The graphic rating scale. Journal of Educational Psychology, 43, 83 - 102 * Hayes, M. H. S. \& D. G. Patterson (1921). Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99

Outcome measures

Outcome measures
Measure	Cyanoacrylate Superior/Inferior n=13 Participants Combined measures of Cyanoacrylate used on both the superior and inferior halves of wounds.	FAG Superior/Inferior n=13 Participants Combined measures of Fast Absorbing Gut Suture used on both the superior and inferior halves of wounds.
Visual Analog Scale (VAS)	7.47 units on a scale Standard Deviation 0.81	7.97 units on a scale Standard Deviation 1.25

Adverse Events

Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Leffell, MD

Yale University

Phone: 203 785 7999

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place