Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01298167
First received: February 15, 2011
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Basal Cell Carcinoma
Squamous Cell Carcinoma
Device: Cyanoacrylate tissue glue versus Fast absorbing gut

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fast Absorbing Gut Suture Versus Cyanoacrylate Tissue Adhesive in the Epidermal Closure of Linear Repairs Following Mohs Micrographic Surgery

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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


Enrollment: 14
Study Start Date: February 2011
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298167

Locations
United States, Connecticut
Yale Dermatologic Surgery
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: David Leffell, MD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01298167     History of Changes
Other Study ID Numbers: 1101007845
Study First Received: February 15, 2011
Results First Received: September 10, 2012
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Cyanoacrylate
Fast Absorbing Gut
Mohs Surgery
Epidermal closure method

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on July 28, 2014