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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02744950
Other study ID # SK1234
Secondary ID
Status Completed
Phase N/A
First received April 14, 2016
Last updated April 15, 2016
Start date November 2013
Est. completion date May 2015

Study information

Verified date April 2016
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Surgical defects on the scalp require closure via various techniques of suture placement. A traditional technique requires both dermal (deep) and epidermal (superficial) placement of sutures to close the defect; this is referred to as intermediate or complex linear repair. However, the scalp is a location with high tension, and thus the closures take an hour or longer to perform. A type of suture placement referred to as the "pulley stitch" requires placement of a few stitches along the defect. The pulley stitch can be used in areas of high tension to close a large defect. The purpose of this study is to compare the scar results and time taken to perform scalp closures via only pulley stitches or via intermediate/complex linear repairs.

To my knowledge, no such study has been performed to compare the two techniques. Such a study would be useful in demonstrating comparable scar appearance and reduce the time to perform scalp closures.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age greater than 18 years

2. Ability to understand risks, benefits, and alternatives to the study and to be able to give an informed consent

3. Lesions such as skin cancer or benign lesions on the scalp amenable to surgical excision or to MOHS surgical technique

4. Frontal scalp defects defined as frontal hair line to crown of scalp

5. Scalp defect size of 2cm - 8 cm

Exclusion criteria:

1. Patients who tend to form keloids or hypertrophic scars

2. Patients with a history of scleroderma or morphea

3. Pregnant or breast-feeding females

4. Patients whose surgical defects require flap closures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Pulley stitches

Intermediate Repair


Locations

Country Name City State
United States Henry Ford Health System- Dermatology Detroit Michigan

Sponsors (1)

Lead Sponsor Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to close wound Time it takes to close the defect in each arm; measured in minutes Depends on case typically 4-10 minutes No
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