Comparison of Fast-Absorbing Sutures for Mohs Surgery

Early Phase 1

• Conditions: Cicatrix
• Interventions: Procedure: Surgical wound closure with superficial absorbable sutures

• Registration Number: NCT02334917
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2014-11-17
• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-06
• Last Update Submitted: 2015-01-06
• Study First Posted: 2015-01-08
• Last Update Posted: 2015-01-08
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients who are over 18 years and are having Mohs surgery on the face.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Absorbable suture closure	Surgical wound closure with superficial absorbable sutures	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.

Primary Outcome Measures

Name	Time	Method
The Stony Brook Scar Evaluation Scale (SBSES) score (cosmetic outcome)	6 months	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)	6 months	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)	6 months	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.