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

Study Overview
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Brief Summary
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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.

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

Conditions
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Brow Ptosis, Surgical Wound

Intervention / Treatment
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* Device: Dermabond
* Other: Non-Absorbable Sutures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 
| Complication Rates | Complication rates of both Dermabond and non-absorbable sutures to include dehiscence and infection | 6 weeks |