Comparison of Fast-Absorbing Sutures for Mohs Surgery

NCT ID: NCT02334917

Last Updated: 2015-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

Cicatrix

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Absorbable suture closure

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.

Group Type: EXPERIMENTAL

Surgical wound closure with superficial absorbable sutures

Intervention Type: 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).

Interventions

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).

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David M Zloty, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Central Contacts

David M Zloty, MD

Role: CONTACT

david.zloty@vch.ca

Luiz C Pantalena, MD, PhD

Role: CONTACT

luiz.pantalena@vch.ca

Other Identifiers

H14-02604

Identifier Type: -

Identifier Source: org_study_id