Fast Absorbing Gut Suture Versus Cyanoacrylate Tissue Adhesive in the Epidermal Closure of Linear Repairs Following Mohs Micrographic Surgery
18 Years
N/A
Both
Basal Cell Carcinoma, Squamous Cell Carcinoma
Trial Information
Fast Absorbing Gut Suture Versus Cyanoacrylate Tissue Adhesive in the Epidermal Closure of Linear Repairs Following Mohs Micrographic Surgery
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Visual Analog Scale (VAS)
Outcome 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
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
David Leffell, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Yale University
Authority:
United States: Institutional Review Board
Study ID:
1101007845
NCT ID:
NCT01298167
Start Date:
February 2011
Completion Date:
August 2012
Related Keywords:
- Basal Cell Carcinoma
- Squamous Cell Carcinoma
- Cyanoacrylate
- Fast Absorbing Gut
- Mohs Surgery
- Epidermal closure method
- Carcinoma
- Carcinoma, Basal Cell
- Carcinoma, Squamous Cell
Name | Location |
|---|---|
| Yale Dermatologic Surgery | New Haven, Connecticut 06510 |
