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Hair Regrowth After Bicoronal Incision

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ClinicalTrials.gov Identifier: NCT01557491
Recruitment Status : Unknown
Verified March 2012 by Dr. Jeff Fialkov, Sunnybrook Health Sciences Centre.
Recruitment status was:  Not yet recruiting
First Posted : March 19, 2012
Last Update Posted : March 19, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Jeff Fialkov, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Alopecia Procedure: Straight Incision Procedure: Bevelled Incision Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Blinded Comparison of Hair Growth Following Either Bevelled or Standard Bi-coronal Scalp Incisions.
Study Start Date : May 2012
Estimated Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Hair Regrowth Within the Scar [ Time Frame: 12 months ]
    Hair growth through the scar will be counted at 6 and 12 month followup


Secondary Outcome Measures :
  1. Scar Characteristics [ Time Frame: 1 year post surgery ]
    Scars will be rated based on the Vancouver Scar Scale (Sullivan, 1990)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): 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

Publications:
Responsible Party: Dr. Jeff Fialkov, Craniofacial Surgeon, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01557491     History of Changes
Other Study ID Numbers: 8080808
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: March 2012

Keywords provided by Dr. Jeff Fialkov, Sunnybrook Health Sciences Centre:
Alopecia
Coronal Incision
Scar Quality

Additional relevant MeSH terms:
Surgical Wound
Alopecia
Alopecia Areata
Wounds and Injuries
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical