Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study (RAVNAS)

April 10, 2015 updated by: University of British Columbia

Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study (RAVNAS)

This study aims to compare scar outcomes between rapidly absorbable and non-absorbable sutures (stitches) for the closure of wounds after skin cancer removal on the face.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • Department of Dermatology and Skin Science, UBC, Vancouver General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mohs surgical wound on the face
  • Wound greater than or equal to 4 cm in length
  • Subject is willing and capable of cooperating to the extent and degree required by the protocol and will be able to come for follow-up assessments
  • Subject has read and signed Subject Information and Informed Consent Form

Exclusion Criteria:

  • Surgical wound less than 4 cm in length
  • Surgical site outside of face
  • Subject to be be treated with radiation therapy after surgery
  • Subject is not willing or able to attend for follow-up assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: rapidly absorbable suture (Vicryl Rapide)
Other: rapidly absorbable suture (Vicryl Rapide)
Active Comparator: non-absorbable suture (Ethilon)
Other: non-absorbable suture (Ethilon)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stony Brook Scar Evaluation Scale (SBSES) score
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: David Zloty, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Estimate)

April 13, 2015

Last Update Submitted That Met QC Criteria

April 10, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-01961

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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