Hair Regrowth After Bicoronal Incision

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Sunnybrook Health Sciences Centre.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Jeff Fialkov, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01557491
First received: March 15, 2012
Last updated: March 16, 2012
Last verified: March 2012
  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.

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557491

Contacts
Contact: Mathew A Plant, MD mplant2008@meds.uwo.ca

Locations
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         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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 August 21, 2014