Comparison of Fast-Absorbing Sutures for Mohs Surgery

NCT02334917 | Unknown Early Phase 1 DMC

• 1 other identifier: H14-02604
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cicatrix

Keywords

Suture Comparison

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Absorbable suture closure

EXPERIMENTAL

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

Interventions

Surgical wound closure with superficial absorbable sutures PROCEDURE

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).

Absorbable suture closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David M Zloty, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David M Zloty, MD

CONTACT

david.zloty@vch.ca

Luiz C Pantalena, MD, PhD

CONTACT

luiz.pantalena@vch.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: January 8, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 8, 2015

Record last verified: 2015-01