Comparison of Fast-Absorbing Sutures for Mohs Surgery
Primary Purpose
Cicatrix
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Surgical wound closure with superficial absorbable sutures
Sponsored by
About this trial
This is an interventional treatment trial for Cicatrix focused on measuring Suture Comparison
Eligibility Criteria
Inclusion Criteria:
- Patients who are over 18 years and are having Mohs surgery on the face.
Exclusion Criteria:
- Patients with surgical wounds less than 4cm in length
- Patients requiring full thickness skin grafts for reconstruction
- Patients who are unable to attend routine postoperative follow-up appointments
- Patients who are receiving radiation therapy after surgery.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Absorbable suture closure
Arm Description
Patients will have half of their surgical wound closed using one kind of absorbable superficial sutures, and the other half with a different kind of absorbable superficial suture. Which half receives which suture will be randomly determined.
Outcomes
Primary Outcome Measures
The Stony Brook Scar Evaluation Scale (SBSES) score (cosmetic outcome)
In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
The Wound Evaluation Scale (WES) score (cosmetic outcome)
In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
The Visual Analogue Scale (VAS) score (cosmetic outcome)
In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
Secondary Outcome Measures
Full Information
NCT ID
NCT02334917
First Posted
November 17, 2014
Last Updated
January 6, 2015
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02334917
Brief Title
Comparison of Fast-Absorbing Sutures for Mohs Surgery
Official Title
Comparison of Fast-Absorbing Sutures for Mohs Surgery Repair on the Face (ComFAS): a Randomized Controlled Split-scar Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being carried out to assess equivalence of scar outcome for two absorbable sutures used for wound closure on the face in dermatologic surgery: rapidly absorbable polyglactin 910 (VicrylRapide™) and fast-absorbing plain gut (5-0 fast). This is important because absorbable sutures are commonly used in Mohs surgery for epidermal closure, yet there is no evidence indicating if any of the sutures above allow for a better cosmetic outcome (less erythema, edema, and scarring).
Detailed Description
Prospective randomized controlled split-scar observer-blinded study.
After dermatologic surgery on the face, surgeons have a choice between using non-absorbable or absorbable sutures for skin closure. A dermatologic surgeon favoring absorbable sutures for wound closure will consider many factors in material selection, including ease of manipulation, cost, and absorption time. However, there have been no randomized trials comparing the most important measure: aesthetic/cosmetic outcome.
Study endpoint/outcome: use three validated scar assessment tools.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix
Keywords
Suture Comparison
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Absorbable suture closure
Arm Type
Experimental
Arm Description
Patients will have half of their surgical wound closed using one kind of absorbable superficial sutures, and the other half with a different kind of absorbable superficial suture. Which half receives which suture will be randomly determined.
Intervention Type
Procedure
Intervention Name(s)
Surgical wound closure with superficial absorbable sutures
Intervention Description
Different superficial absorbable sutures will be used in the closure of skin wounds after Mohs surgery. No drugs or devices are being compared, only the two different absorbable sutures (Vicryl Rapide and Fast Absorbing Gut).
Primary Outcome Measure Information:
Title
The Stony Brook Scar Evaluation Scale (SBSES) score (cosmetic outcome)
Description
In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
Time Frame
6 months
Title
The Wound Evaluation Scale (WES) score (cosmetic outcome)
Description
In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
Time Frame
6 months
Title
The Visual Analogue Scale (VAS) score (cosmetic outcome)
Description
In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who are over 18 years and are having Mohs surgery on the face.
Exclusion Criteria:
Patients with surgical wounds less than 4cm in length
Patients requiring full thickness skin grafts for reconstruction
Patients who are unable to attend routine postoperative follow-up appointments
Patients who are receiving radiation therapy after surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David M Zloty, MD
Email
david.zloty@vch.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Luiz C Pantalena, MD, PhD
Email
luiz.pantalena@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Zloty, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of Fast-Absorbing Sutures for Mohs Surgery
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