Comparison of Fast-Absorbing Sutures for Mohs Surgery

Cicatrix Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02334917
• Other study ID #: H14-02604
• Status: Not yet recruiting
• Phase: Phase 0
• First received: November 17, 2014
• Last updated: January 6, 2015
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: January 2015
• Source: University of British Columbia
• Contact: David M Zloty, MD
• Email: david.zloty[@]vch.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix

Intervention

Procedure:
• Surgical wound closure with superficial absorbable sutures
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No