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

NCT ID: NCT05981443

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2024-04-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Comparator: Dermabond

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

Group Type: EXPERIMENTAL

Dermabond

Intervention Type: DEVICE

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

Active Comparator: Non-Absorbable Sutures

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

Group Type: ACTIVE_COMPARATOR

Non-Absorbable Sutures

Intervention Type: OTHER

Use of conventional non-absorbable sutures to close surgical incisions

Interventions

Dermabond

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

Intervention Type: DEVICE

Non-Absorbable Sutures

Use of conventional non-absorbable sutures to close surgical incisions

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cody Blanchard

OTHER

Sponsor Role: lead

Responsible Party

Cody Blanchard

Resident Physician, Ophthalmology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter Timoney, MD

Role: STUDY_DIRECTOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

BrowPtosis

Identifier Type: -

Identifier Source: org_study_id