Back to resultsRapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study (RAVNAS)
Primary Purpose
Scars
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
rapidly absorbable suture (Vicryl Rapide)
non-absorbable suture (Ethilon)
Sponsored by
About this trial
This is an interventional treatment trial for Scars focused on measuring Scar outcome, Mohs surgery, face
Eligibility 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
Sites / Locations
- Department of Dermatology and Skin Science, UBC, Vancouver General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
rapidly absorbable suture (Vicryl Rapide)
non-absorbable suture (Ethilon)
Arm Description
Outcomes
Primary Outcome Measures
Stony Brook Scar Evaluation Scale (SBSES) score
Secondary Outcome Measures
Full Information
NCT ID
NCT01932359
First Posted
August 27, 2013
Last Updated
April 10, 2015
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01932359
Brief Title
Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study
Acronym
RAVNAS
Official Title
Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study (RAVNAS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scars
Keywords
Scar outcome, Mohs surgery, face
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rapidly absorbable suture (Vicryl Rapide)
Arm Type
Active Comparator
Arm Title
non-absorbable suture (Ethilon)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
rapidly absorbable suture (Vicryl Rapide)
Intervention Type
Other
Intervention Name(s)
non-absorbable suture (Ethilon)
Primary Outcome Measure Information:
Title
Stony Brook Scar Evaluation Scale (SBSES) score
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Zloty, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology and Skin Science, UBC, Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study
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