Comparison of Fast-Absorbing Sutures for Mohs Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Fast-Absorbing Sutures for Mohs Surgery Repair on the Face (ComFAS): a Randomized Controlled Split-scar Study

Conditions
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Cicatrix

Intervention / Treatment
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* Procedure: Surgical wound closure with superficial absorbable sutures


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Absorbable suture closure<br>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. | Procedure: Surgical wound closure with superficial absorbable sutures<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suture Comparison