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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01557491
Other study ID # 8080808
Secondary ID
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. completion date
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


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
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