NCT01557491

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Last Updated

March 19, 2012

Status Verified

March 1, 2012

Enrollment Period

1.5 years

First QC Date

March 15, 2012

Last Update Submit

March 16, 2012

Conditions

Alopecia

Keywords

AlopeciaCoronal IncisionScar Quality

Outcome Measures

Primary Outcomes (1)

  • Hair Regrowth Within the Scar

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

    12 months

Secondary Outcomes (1)

  • Scar Characteristics

    1 year post surgery

Study Arms (2)

Straight Incision

ACTIVE COMPARATOR

incision made perpendicular to scalp surface

Procedure: Straight Incision

Bevelled Incision

ACTIVE COMPARATOR

Incision made at 45 degrees to scalp surface

Procedure: Bevelled Incision

Interventions

Straight IncisionPROCEDURE

The incision will be made at a 90 degree angle to the surface of the scalp

Straight Incision
Bevelled IncisionPROCEDURE

The Incision will be made at a 45 degree angle to the surface of the scalp.

Bevelled Incision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bicoronal Incision required as part of surgical plan
  • Incision within hair-bearing scalp

You may not qualify if:

  • Previous Bicoronal Incision
  • Unfit for Surgery
  • Unable to provide informed consent
  • Unable to comply with followup
  • Preexisting alopecia of scalp
  • Cutaneous malignancy of scalp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Related 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. doi: 10.1097/00006534-199701000-00002.

    PMID: 8982181BACKGROUND

  • 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. doi: 10.1097/00004630-199005000-00014.

    PMID: 2373734BACKGROUND

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mathew A Plant, MD

    University of Toronto Plastic and Reconstructive Surgery

    STUDY DIRECTOR

Central Study Contacts

Mathew A Plant, MD

CONTACT

mplant2008@meds.uwo.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Craniofacial Surgeon

Study Record Dates

First Submitted

March 15, 2012

First Posted

March 19, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2013

Last Updated

March 19, 2012

Record last verified: 2012-03

Locations

CA(1)