Hair Regrowth After Bicoronal Incision
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Alopecia |
Procedure: Straight Incision Procedure: Bevelled Incision |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized Blinded Comparison of Hair Growth Following Either Bevelled or Standard Bi-coronal Scalp Incisions. |
- Hair Regrowth Within the Scar [ Time Frame: 12 months ] [ Designated as safety issue: No ]Hair growth through the scar will be counted at 6 and 12 month followup
- Scar Characteristics [ Time Frame: 1 year post surgery ] [ Designated as safety issue: No ]Scars will be rated based on the Vancouver Scar Scale (Sullivan, 1990)
| Estimated Enrollment: | 26 |
| Study Start Date: | May 2012 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Straight Incision
incision made perpendicular to scalp surface
|
Procedure: Straight Incision
The incision will be made at a 90 degree angle to the surface of the scalp
|
|
Active Comparator: Bevelled Incision
Incision made at 45 degrees to scalp surface
|
Procedure: Bevelled Incision
The Incision will be made at a 45 degree angle to the surface of the scalp.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Mathew A Plant, MD | mplant2008@meds.uwo.ca |
| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | Not yet recruiting |
| Toronto, Ontario, Canada, M4N3M5 | |
| Contact: Jeffrey Fialkov, MD 4164804257 | |
| Principal Investigator: Jeffrey Fialkov, MD, FRCSC | |
| Sub-Investigator: Mathew A Plant, MD | |
| Study Director: | Mathew A Plant, MD | University of Toronto Plastic and Reconstructive Surgery |
More Information
Publications:
| Responsible Party: | Dr. Jeff Fialkov, Craniofacial Surgeon, Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT01557491 History of Changes |
| Other Study ID Numbers: | 8080808 |
| Study First Received: | March 15, 2012 |
| Last Updated: | March 16, 2012 |
| Health Authority: | Canada: Ministry of Health & Long Term Care, Ontario |
Keywords provided by Sunnybrook Health Sciences Centre:
|
Alopecia Coronal Incision Scar Quality |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 22, 2013