An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures

Surgical Wound Clinical Trial

Official title:

Scar Analysis in Direct Excision Brow Lift: Comparing Octyl-2- Cyanoacrylate (Dermabond) Versus Non-absorbable Sutures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05981443
• Other study ID #: BrowPtosis
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brow Ptosis
• Prolapse
• Surgical Wound

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