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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05981443
Other study ID # BrowPtosis
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 15, 2023
Est. completion date June 2024

Study information

Verified date September 2023
Source University of Kentucky
Contact Cody Blanchard, MD
Phone 859-323-5875
Email cody.blanchard@uky.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare Dermabond with non-absorbable sutures in skin closure after brow ptosis surgery. The main questions it aims to answer are: - if Dermabond provides equivalent wound healing compared to conventional non-absorbable skin suture techniques - if Dermabond provides equivalent scar appearance compared to conventional non-absorbable suture techniques - if Dermabond results in equivalent complication rates compared to conventional non-absorbable suture techniques Participants will have be randomly selected to have either Dermabond or non-absorbable suture closure methods. Scar analysis and both participant and provider surveys will be performed to assess the differences between groups, if any.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Patients undergoing bilateral direct excision brow lift for brow ptosis at the University of Kentucky Medical Center. - Patients > 18 years of age. - Patients must be able to follow up at the specified intervals. - Patients who are able to give their own informed consent. - Health Status: Variable health status reflective of general population of Kentucky. Patients will be healthy enough to be seen in an office setting. - All patients will need to be proficient in the English language to understand the scale used for scar assessment Exclusion Criteria: - Patients <18 years of age or >100 - Allergy to Dermabond - Adults with impaired consent capacity - Incarcerated individuals

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Dermabond
Use of Dermabond to close surgical incisions instead of non-absorbable sutures
Other:
Non-Absorbable Sutures
Use of conventional non-absorbable sutures to close surgical incisions

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (1)

Lead Sponsor Collaborator
Cody Blanchard

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scar Appearance Patient and Observer Scar Assessment Scale filled out by both patient and provider at both postoperative visits of both Dermabond and non-absorbable sutures. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey. 10 days
Primary Scar Appearance Patient and Observer Scar Assessment Scale filled out by both patient and provider at both postoperative visits of both Dermabond and non-absorbable sutures. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey. 6 weeks
Primary Complication Rates Complication rates of both Dermabond and non-absorbable sutures to include dehiscence and infection 6 weeks
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