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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

March 15, 2012
March 16, 2012
May 2012
November 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01557491 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Hair Regrowth After Bicoronal Incision
A Randomized Blinded Comparison of Hair Growth Following Either Bevelled or Standard Bi-coronal Scalp Incisions.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Alopecia
  • Procedure: Straight Incision
    The incision will be made at a 90 degree angle to the surface of the scalp
  • Procedure: Bevelled Incision
    The Incision will be made at a 45 degree angle to the surface of the scalp.
  • Active Comparator: Straight Incision
    incision made perpendicular to scalp surface
    Intervention: Procedure: Straight Incision
  • Active Comparator: Bevelled Incision
    Incision made at 45 degrees to scalp surface
    Intervention: Procedure: Bevelled Incision

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
26
Not Provided
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mathew A Plant, MD mplant2008@meds.uwo.ca
Canada
 
NCT01557491
8080808
Not Provided
Dr. Jeff Fialkov, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Not Provided
Study Director: Mathew A Plant, MD University of Toronto Plastic and Reconstructive Surgery
Sunnybrook Health Sciences Centre
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP