Hair Regrowth After Bicoronal Incision

March 16, 2012 updated by: Dr. Jeff Fialkov, Sunnybrook Health Sciences Centre

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hair Regrowth Within the Scar
Time Frame: 12 months
Hair growth through the scar will be counted at 6 and 12 month followup
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scar Characteristics
Time Frame: 1 year post surgery
Scars will be rated based on the Vancouver Scar Scale (Sullivan, 1990)
1 year post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

November 1, 2013

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

March 15, 2012

First Submitted That Met QC Criteria

March 16, 2012

First Posted (Estimate)

March 19, 2012

Study Record Updates

Last Update Posted (Estimate)

March 19, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8080808

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alopecia

Clinical Trials on Straight Incision

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe