Hair Regrowth After Bicoronal Incision
Primary Purpose
Alopecia
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Straight Incision
Bevelled Incision
Sponsored by
About this trial
This is an interventional prevention trial for Alopecia focused on measuring Alopecia, Coronal Incision, Scar Quality
Eligibility Criteria
Inclusion Criteria:
- Bicoronal Incision required as part of surgical plan
- Incision within hair-bearing scalp
Exclusion Criteria:
- Previous Bicoronal Incision
- Unfit for Surgery
- Unable to provide informed consent
- Unable to comply with followup
- Preexisting alopecia of scalp
- Cutaneous malignancy of scalp
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Straight Incision
Bevelled Incision
Arm Description
incision made perpendicular to scalp surface
Incision made at 45 degrees to scalp surface
Outcomes
Primary Outcome Measures
Hair Regrowth Within the Scar
Hair growth through the scar will be counted at 6 and 12 month followup
Secondary Outcome Measures
Scar Characteristics
Scars will be rated based on the Vancouver Scar Scale (Sullivan, 1990)
Full Information
NCT ID
NCT01557491
First Posted
March 15, 2012
Last Updated
March 16, 2012
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01557491
Brief Title
Hair Regrowth After Bicoronal Incision
Official Title
A Randomized Blinded Comparison of Hair Growth Following Either Bevelled or Standard Bi-coronal Scalp Incisions.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
5. Study Description
Brief Summary
Loss of hair growth potential in long surgical scalp incisions can become obvious to the patient and others, given hair's tendency to part along the resulting scar. Bevelling incisions perpendicular to the hair follicle angle may increase hair growth through the scar. However, many factors may be confounders such as wound tension and cauterizing the incision. This study will investigate the effect a bevelled incision has on hair growth preservation compared to a standard incision that incises the skin perpendicular to its surface irrespective of hair follicle angles. Following informed voluntary consent, subjects who require bi-coronal scalp incisions as part of a surgical plan will be enrolled. The right side of this bilateral incision will be randomized to receive either a bevelled or a standard incision and the left side will receive the opposite type. During routine surgical follow-up the hair growth within the scar of the two sides will be recorded for comparison and it is our hypothesis that the side with the bevelled incision will have more hair within the scar.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia
Keywords
Alopecia, Coronal Incision, Scar Quality
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Straight Incision
Arm Type
Active Comparator
Arm Description
incision made perpendicular to scalp surface
Arm Title
Bevelled Incision
Arm Type
Active Comparator
Arm Description
Incision made at 45 degrees to scalp surface
Intervention Type
Procedure
Intervention Name(s)
Straight Incision
Intervention Description
The incision will be made at a 90 degree angle to the surface of the scalp
Intervention Type
Procedure
Intervention Name(s)
Bevelled Incision
Intervention Description
The Incision will be made at a 45 degree angle to the surface of the scalp.
Primary Outcome Measure Information:
Title
Hair Regrowth Within the Scar
Description
Hair growth through the scar will be counted at 6 and 12 month followup
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Scar Characteristics
Description
Scars will be rated based on the Vancouver Scar Scale (Sullivan, 1990)
Time Frame
1 year post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bicoronal Incision required as part of surgical plan
Incision within hair-bearing scalp
Exclusion Criteria:
Previous Bicoronal Incision
Unfit for Surgery
Unable to provide informed consent
Unable to comply with followup
Preexisting alopecia of scalp
Cutaneous malignancy of scalp
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathew A Plant, MD
Email
mplant2008@meds.uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathew A Plant, MD
Organizational Affiliation
University of Toronto Plastic and Reconstructive Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Fialkov, MD
Phone
4164804257
First Name & Middle Initial & Last Name & Degree
Jeffrey Fialkov, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Mathew A Plant, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
8982181
Citation
Camirand A, Doucet J. A comparison between parallel hairline incisions and perpendicular incisions when performing a face lift. Plast Reconstr Surg. 1997 Jan;99(1):10-5. doi: 10.1097/00006534-199701000-00002.
Results Reference
background
PubMed Identifier
2373734
Citation
Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.
Results Reference
background
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Hair Regrowth After Bicoronal Incision
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