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Trial record 90 of 531 for:    "Skin cancer"

Patient Satisfaction After Facial Reconstruction

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ClinicalTrials.gov Identifier: NCT02230462
Recruitment Status : Unknown
Verified October 2014 by University of British Columbia.
Recruitment status was:  Not yet recruiting
First Posted : September 3, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Skin Neoplasms Other: Viewing of cancer excision defect Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Visualization of Pre-operative Defects on Patient Satisfaction After Facial Reconstruction for Skin Cancer Resection.
Study Start Date : October 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Viewing of cancer excision defect
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
Patients will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction.

No Intervention: No viewing of cancer excision defect
Patients in this arm of the study will not be invited to view their cancer excision defect prior to its reconstruction.



Primary Outcome Measures :
  1. Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction. [ Time Frame: The day of 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.


Secondary Outcome Measures :
  1. Ability to recall cancer excision defect size. [ Time Frame: 3 months after reconstruction ]
    Patients will be asked to draw what they recall to be the size of their cancer excision defect prior to its reconstruction. This will be done at the final routine surgical follow up appointment (3 months after surgery).

  2. Symptomatic scarring [ Time Frame: 3 months after reconstruction ]
    Patients will complete survey questions to determine whether they are bothered by their scar appearance, texture or any neuropathic symptoms.

  3. Persistence of patient satisfaction with the cosmetic appearance of their skin cancer reconstruction. [ Time Frame: 2 weeks, and 3 months after reconstruction. ]
    Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction site will be reassessed on a ten point scale at the two week and 3 month routine followup appointments.


Other Outcome Measures:
  1. Skindex -16 [ Time Frame: The day of reconstruction, 2 weeks, and 3 months after reconstruction. ]
    Patient quality of life relating to their skin cancer will be assessed using the Skindex-16 (a validated tool for this purpose).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230462


Locations
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Canada, British Columbia
Dermatology & Skin Science (UBC), The Skin Care Centre Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4E8
Contact: Bryce J Cowan, MD, PhD    604-875-4888    skinsurg@gmail.com   
Contact: Jorga Zabojova, MD, PhD       jorga.zabojova@gmail.com   
Principal Investigator: Bryce J Cowan, MD, PhD         
Sub-Investigator: Jorga Zabojova, MD, PhD         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Bryce J Cowan, MD, PhD University of British Columbia

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02230462     History of Changes
Other Study ID Numbers: H13-02922
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014
Keywords provided by University of British Columbia:
patient satisfaction
Mohs surgery
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases