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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01932359
First received: August 27, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Scars
Other: rapidly absorbable suture (Vicryl Rapide)
Other: non-absorbable suture (Ethilon)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study (RAVNAS)

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Stony Brook Scar Evaluation Scale (SBSES) score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rapidly absorbable suture (Vicryl Rapide) Other: rapidly absorbable suture (Vicryl Rapide)
Active Comparator: non-absorbable suture (Ethilon) Other: non-absorbable suture (Ethilon)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932359

Locations
Canada, British Columbia
Department of Dermatology and Skin Science, UBC, Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 4E8
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: David Zloty, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01932359     History of Changes
Other Study ID Numbers: H13-01961
Study First Received: August 27, 2013
Last Updated: March 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Scar outcome
Mohs surgery
face

ClinicalTrials.gov processed this record on October 21, 2014