Clinical trial NCT01298167: 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
Overall status: COMPLETED
Phase: NA
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma
Keywords: Cyanoacrylate
Fast Absorbing Gut
Mohs Surgery
Epidermal closure method
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Dermatologic Surgery
state: Connecticut
Study officials:
affiliation: Yale University
name: David Leffell, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.