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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound; Brow Ptosis
• Intervention / Treatment: Device: Dermabond; Other: Non-Absorbable Sutures

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Comparator: Dermabond; The surgical wound over one eyebrow will be closed with Dermabond.	Device: Dermabond; Use of Dermabond to close surgical incisions instead of non-absorbable sutures
Active Comparator: Active Comparator: Non-Absorbable Sutures; The surgical wound over one eyebrow will be closed with non-absorbable sutures.	Other: Non-Absorbable Sutures; Use of conventional non-absorbable sutures to close surgical incisions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of Participants With Complications	Complications of both Dermabond and non-absorbable sutures to include dehiscence and infection	6 weeks

Collaborators and Investigators

• Sponsor: Cody Blanchard
• Investigators: Study Director: Peter Timoney, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Actual): April 17, 2024
• Study Completion (Actual): April 17, 2024

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pathological Conditions, Anatomical; Surgical Wound; Prolapse
• Other Study ID Numbers: BrowPtosis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes