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

NCT05981443 | Completed Results FDA Device

• 1 other identifier: BrowPtosis
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brow Ptosis; Surgical Wound

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Active Comparator: Dermabond

EXPERIMENTAL

The surgical wound over one eyebrow will be closed with Dermabond.

Device: Dermabond

Active Comparator: Non-Absorbable Sutures

ACTIVE COMPARATOR

The surgical wound over one eyebrow will be closed with non-absorbable sutures.

Other: Non-Absorbable Sutures

Interventions

Dermabond DEVICE

Use of Dermabond to close surgical incisions instead of non-absorbable sutures

Active Comparator: Dermabond

Non-Absorbable Sutures OTHER

Use of conventional non-absorbable sutures to close surgical incisions

Active Comparator: Non-Absorbable Sutures

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients \<18 years of age or \>100
• Allergy to Dermabond
• Adults with impaired consent capacity
• Incarcerated individuals

Sponsors & Collaborators

• Cody Blanchard: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Dr. Cody Blanchard
• Organization: University of Kentucky

cody.blanchard@uky.edu

859-323-5867

Study Officials

• Peter Timoney, MD

  University of Kentucky

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician, Ophthalmology

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: August 15, 2023
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Locations

US (1)