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Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery

Primary Purpose

Basal Cell Carcinoma, Squamous Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cyanoacrylate tissue glue versus Fast absorbing gut
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring Cyanoacrylate, Fast Absorbing Gut, Mohs Surgery, Epidermal closure method

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Yale Dermatologic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cyanoacrylate Superior/Inferior

Fast Absorbing Gut Suture Superior/Inferior

Arm Description

This 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.

This 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 15, 2011
Last Updated
October 10, 2012
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01298167
Brief Title
Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery
Official Title
Fast Absorbing Gut Suture Versus Cyanoacrylate Tissue Adhesive in the Epidermal Closure of Linear Repairs Following Mohs Micrographic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Cyanoacrylate is a rapidly polymerizing topical adhesive commonly used as an alternative to traditional sutures. Both cyanoacrylate and fast absorbing gut suture eliminate the need for suture removal which can represent a significant savings in patient and staff time as well as related healthcare resources. Both cyanoacrylate and fast absorbing gut suture are currently routinely used for epidermal closure at Yale following Mohs micrographic surgery. Physician preference currently dictates which epidermal closure method is chosen for a given surgery. Cyanoacrylate has been reported to decrease trauma to the epidermal edges, minimize suture tract marks in surgical scars, and decrease the risk of inflammatory reaction to suture material. Cyanoacrylate, however, does not allow for wound eversion. Wound eversion minimizes the risk of a depressed scar from tissue contraction during healing. As with all sutures, fast absorbing gut suture allows for wound eversion which is reported to maximize the likelihood of a good epidermal approximation. On the other hand, fast absorbing gut suture degrades by proteolysis which can result in an inflammatory reaction. Any inflammatory reaction on the skin while healing can affect the final cosmetic outcome (ie. post-inflammatory hyperpigmentation). A recent article (Tierney 2009), reported that tissue adhesive may not be as effective in achieving optimal cosmesis as fast absorbing gut for defects on the trunk and extremities. However, we would like to study these two methods for the repair of facial wounds, which are in low tension areas as compared to trunk and extremities. Therefore, it is unknown exactly which of these two method is better than the other in epidermal closure of facial wounds follow Mohs micrographic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Squamous Cell Carcinoma
Keywords
Cyanoacrylate, Fast Absorbing Gut, Mohs Surgery, Epidermal closure method

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyanoacrylate Superior/Inferior
Arm Type
Active Comparator
Arm Description
This 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.
Arm Title
Fast Absorbing Gut Suture Superior/Inferior
Arm Type
Active Comparator
Arm Description
This 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.
Intervention Type
Device
Intervention Name(s)
Cyanoacrylate tissue glue versus Fast absorbing gut
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Leffell, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Dermatologic Surgery
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25741400
Citation
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.
Results Reference
derived

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Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery

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