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Hair Regrowth After Bicoronal Incision

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Unknown status
CT.gov ID
NCT01557491
Collaborator
(none)
26
Enrollment
1
Location
2
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Straight Incision
  • Procedure: Bevelled Incision
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 1, 2012
Anticipated Primary Completion Date :
Nov 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Hair Regrowth Within the Scar [12 months]

    Hair growth through the scar will be counted at 6 and 12 month followup

Secondary Outcome Measures

  1. Scar Characteristics [1 year post surgery]

    Scars will be rated based on the Vancouver Scar Scale (Sullivan, 1990)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N3M5

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre

Investigators

  • Study Director: Mathew A Plant, MD, University of Toronto Plastic and Reconstructive Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Jeff Fialkov, Craniofacial Surgeon, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01557491
Other Study ID Numbers:
  • 8080808
First Posted:
Mar 19, 2012
Last Update Posted:
Mar 19, 2012
Last Verified:
Mar 1, 2012
Keywords provided by Dr. Jeff Fialkov, Craniofacial Surgeon, Sunnybrook Health Sciences Centre
Alopecia
Coronal Incision
Scar Quality
Additional relevant MeSH terms:
Alopecia

Study Results

No Results Posted as of Mar 19, 2012