Hair Regrowth After Bicoronal Incision

Alopecia Clinical Trial

Official title:

A Randomized Blinded Comparison of Hair Growth Following Either Bevelled or Standard Bi-coronal Scalp Incisions.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01557491
• Other study ID #: 8080808
• Status: Not yet recruiting
• Phase: N/A
• First received: March 15, 2012
• Last updated: March 16, 2012
• Start date: May 2012

Study information

• Verified date: March 2012
• Source: Sunnybrook Health Sciences Centre
• Contact: Mathew A Plant, MD
• Email: mplant2008[@]meds.uwo.ca
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alopecia

Intervention

Procedure:
• Straight Incision
The incision will be made at a 90 degree angle to the surface of the scalp
• Bevelled Incision
The Incision will be made at a 45 degree angle to the surface of the scalp.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Camirand A, Doucet J. A comparison between parallel hairline incisions and perpendicular incisions when performing a face lift. Plast Reconstr Surg. 1997 Jan;99(1):10-5. — View Citation

Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair Regrowth Within the Scar	Hair growth through the scar will be counted at 6 and 12 month followup	12 months	No
Secondary	Scar Characteristics	Scars will be rated based on the Vancouver Scar Scale (Sullivan, 1990)	1 year post surgery	No