NCT01932359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

August 27, 2013

Last Update Submit

April 10, 2015

Conditions

Scars

Keywords

Scar outcomeMohs surgeryface

Outcome Measures

Primary Outcomes (1)

  • Stony Brook Scar Evaluation Scale (SBSES) score

    6 months

Study Arms (2)

rapidly absorbable suture (Vicryl Rapide)

ACTIVE COMPARATOR
Other: rapidly absorbable suture (Vicryl Rapide)

non-absorbable suture (Ethilon)

ACTIVE COMPARATOR
Other: non-absorbable suture (Ethilon)

Interventions

rapidly absorbable suture (Vicryl Rapide)OTHER
rapidly absorbable suture (Vicryl Rapide)
non-absorbable suture (Ethilon)OTHER
non-absorbable suture (Ethilon)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology and Skin Science, UBC, Vancouver General Hospital

Vancouver, British Columbia, V5Z 4E8, Canada

Location

MeSH Terms

Conditions

CicatrixFacies

Interventions

Nylons

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

PlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • David Zloty, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

August 30, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2014

Study Completion

November 1, 2014

Last Updated

April 13, 2015

Record last verified: 2015-04

Locations

CA(1)