Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery
Fast Absorbing Gut Suture Versus Cyanoacrylate Tissue Adhesive in the Epidermal Closure of Linear Repairs Following Mohs Micrographic Surgery
1 other identifier
interventional
14
1 country
1
Brief Summary
The purpose of the study is to look at which nonpermanent superficial closure method, cyanoacrylate tissue glue or fast absorbing gut suture, leads to a better cosmetic and functional outcome in repairs of facial wounds after Mohs surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 15, 2011
CompletedFirst Posted
Study publicly available on registry
February 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
November 9, 2012
CompletedNovember 9, 2012
October 1, 2012
6 months
February 15, 2011
September 10, 2012
October 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale (VAS)
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
3 months
Study Arms (2)
Cyanoacrylate Superior/Inferior
ACTIVE COMPARATORThis arm contains data from only the Cyanoacrylate used on superior ½ of wounds \& inferior ½ of wounds in randomized patients to determine the impact of Cyanoacrylate tissue glue versus Fast Absorbing Gut suture.
Fast Absorbing Gut Suture Superior/Inferior
ACTIVE COMPARATORThis arm contains data from only the Fast Absorbing Gut Suture used on superior ½ of wounds \& inferior ½ of wounds in randomized patients to determine the impact of Cyanoacrylate tissue glue versus Fast absorbing gut suture.
Interventions
All wounds will be closed using a linear, bilayered closure method, where the buried intradermal absorbing suture (5-0, Polysorb) will be placed along the length of the incision, consistent with standard surgical procedure. Only patients with wounds with a length of 3cm or greater will be enrolled. Each wound will be measured, and the length divided in half. Half of the surgical wound will be randomly selected (by coin toss) for epidermal reapproximation with cyanoacrylate, whereas the other half will be repaired with 6-0 fast absorbing gut suture in standard running fashion.
Eligibility Criteria
You may qualify if:
- The subject is willing and able to give informed consent.
- The subject is willing and able to participate in the study as an outpatient and is willing to comply with study requirements.
- The subject is 18 years of age or older.
- The subject has a diagnosis of a non-melanoma skin cancer on the face requiring Mohs micrographic surgery.
- The subjects also has a final wound length of 3cm or greater.
- The subject is able to abide by the protocol of standard postoperative care and is able to attend standard post-operative visits at 3 months after the surgery.
You may not qualify if:
- The subject is on systemic immunosuppressants and/or is an organ transplant recipients.
- The subject has reported or suspected hypersensitivity to cyanoacrylate or fast absorbing gut suture.
- The subject has a dermatologic disease in the target site that may interfere with examination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale Dermatologic Surgery
New Haven, Connecticut, 06510, United States
Related Publications (1)
Kim J, Singh Maan H, Cool AJ, Hanlon AM, Leffell DJ. Fast Absorbing Gut Suture versus Cyanoacrylate Tissue Adhesive in the Epidermal Closure of Linear Repairs Following Mohs Micrographic Surgery. J Clin Aesthet Dermatol. 2015 Feb;8(2):24-9.
PMID: 25741400DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Leffell, MD
- Organization
- Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
David Leffell, MD
Yale University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2011
First Posted
February 17, 2011
Study Start
February 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2012
Last Updated
November 9, 2012
Results First Posted
November 9, 2012
Record last verified: 2012-10