ScarsRAVNASNCT01932359
Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study
A study testing rapidly absorbable suture (Vicryl Rapide) and non-absorbable suture (Ethilon) in people with Scars, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scars
- What is being tested?
- rapidly absorbable suture (Vicryl Rapide) and non-absorbable suture (Ethilon)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Dermatology and Skin Science, UBC, Vancouver General Hospital
Vancouver, British Columbia, V5Z 4E8
About this study
Official title: 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.
- Conditions
- Scars
- Being tested
- rapidly absorbable suture (Vicryl Rapide), non-absorbable suture (Ethilon)
- Keywords
- Scar outcome, Mohs surgery, face
- Medical subject headings
- Cicatrix, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapidly absorbable suture (Vicryl Rapide)Other
non-absorbable suture (Ethilon)Other
| Study group | Role | What they receive |
|---|---|---|
| rapidly absorbable suture (Vicryl Rapide) | Active comparator | Not described Receives: Other: rapidly absorbable suture (Vicryl Rapide) |
| non-absorbable suture (Ethilon) | Active comparator | Not described Receives: Other: non-absorbable suture (Ethilon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stony Brook Scar Evaluation Scale (SBSES) score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Zloty, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932359
- Sponsor's protocol ID
- H13-01961
- Acronym
- RAVNAS
- Status last verified
- Apr 2015
- First submitted
- 27 Aug 2013
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study (RAVNAS)
- ClinicalTrials.gov ID
- NCT01932359
- Acronym / sponsor ID
- RAVNAS / H13-01961
- Conditions
- Scars
- Keywords
- Scar outcome, Mohs surgery, face
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rapidly absorbable suture (Vicryl Rapide) | Active comparator | Other: rapidly absorbable suture (Vicryl Rapide) |
| non-absorbable suture (Ethilon) | Active comparator | Other: non-absorbable suture (Ethilon) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapidly absorbable suture (Vicryl Rapide) | Other | rapidly absorbable suture (Vicryl Rapide) |
| non-absorbable suture (Ethilon) | Other | non-absorbable suture (Ethilon) |
Primary outcome
Stony Brook Scar Evaluation Scale (SBSES) score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Zloty, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rapidly absorbable suture (Vicryl Rapide) and non-absorbable suture (Ethilon) in people with Scars, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stony Brook Scar Evaluation Scale (SBSES) score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.