NCT02230462

Brief Summary

The purpose of this study is to assess the effects of visualization of skin cancer resection defects on the face on the post-operative satisfaction of patients after their reconstruction. To achieve this aim, patients invited to participate in this study will be randomized to either seeing or not seeing their skin cancer excision defect prior to reconstruction. After reconstruction, patient satisfaction will be assessed in both groups to determine if visualization of the defect prior to reconstruction has any effect on patient satisfaction and if any detected effect has durability over time.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 6, 2014

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

July 16, 2014

Last Update Submit

October 2, 2014

Conditions

Skin Neoplasms

Keywords

patient satisfactionMohs surgery

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.

    Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction site will be assessed on a ten point scale on the day of surgery.

    The day of reconstruction.

Secondary Outcomes (3)

  • Ability to recall cancer excision defect size.

    3 months after reconstruction

  • Symptomatic scarring

    3 months after reconstruction

  • Persistence of patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.

    2 weeks, and 3 months after reconstruction.

Other Outcomes (1)

  • Skindex -16

    The day of reconstruction, 2 weeks, and 3 months after reconstruction.

Study Arms (2)

Viewing of cancer excision defect

EXPERIMENTAL

Patients in this arm of the study will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction.

Other: Viewing of cancer excision defect

No viewing of cancer excision defect

NO INTERVENTION

Patients in this arm of the study will not be invited to view their cancer excision defect prior to its reconstruction.

Interventions

Viewing of cancer excision defectOTHER

Patients will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction.

Viewing of cancer excision defect

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients recruited for this study must undergo Mohs resection of skin cancer of the face with negative margins at the completion of their cancer resection.
  • Patients recruited for this study must have a post cancer resection defect on the face at least 1.5 centimeters in size in the greatest dimension.
  • Patients recruited for this study must undergo single stage repair of their post cancer resection defect with primary closure or local flaps.
  • Patients must be from the Greater Vancouver area.

You may not qualify if:

  • Patients with insufficient visual acuity to be able to appreciate wound and scarring changes to their face post-operatively will be excluded.
  • Patients lacking the cognitive capacity to complete the data collection forms utilized in this study will be excluded.
  • Patients suffering from significant psychiatric conditions will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology & Skin Science (UBC), The Skin Care Centre

Vancouver, British Columbia, V5Z 4E8, Canada

Location

MeSH Terms

Conditions

Skin NeoplasmsPatient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Bryce J Cowan, MD, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2014

First Posted

September 3, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

October 6, 2014

Record last verified: 2014-10

Locations

CA(1)