Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery
NCT ID: NCT01298167
Last Updated: 2012-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2011-02-28
2012-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cyanoacrylate Superior/Inferior
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.
Cyanoacrylate tissue glue versus Fast absorbing gut
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.
Fast Absorbing Gut Suture Superior/Inferior
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.
Cyanoacrylate tissue glue versus Fast absorbing gut
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.
Interventions
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Cyanoacrylate tissue glue versus Fast absorbing gut
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
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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David Leffell, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale Dermatologic Surgery
New Haven, Connecticut, United States
Countries
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References
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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.
Other Identifiers
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1101007845
Identifier Type: -
Identifier Source: org_study_id