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

Sponsor
Cody Blanchard (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05981443
Collaborator
(none)
60
2
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Dermabond
  • Other: Non-Absorbable Sutures
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Scar Analysis in Direct Excision Brow Lift: Comparing Octyl-2- Cyanoacrylate (Dermabond) Versus Non-absorbable Sutures
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Scar Appearance [10 days]

    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.

  2. Scar Appearance [6 weeks]

    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.

  3. Complication Rates [6 weeks]

    Complication rates of both Dermabond and non-absorbable sutures to include dehiscence and infection

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cody Blanchard

Investigators

  • Study Director: Peter Timoney, MD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cody Blanchard, Resident Physician, Ophthalmology, University of Kentucky
ClinicalTrials.gov Identifier:
NCT05981443
Other Study ID Numbers:
  • BrowPtosis
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023