Surgical Wound Clinical Trial
Official title:
Scar Analysis in Direct Excision Brow Lift: Comparing Octyl-2- Cyanoacrylate (Dermabond) Versus Non-absorbable Sutures
NCT number | NCT05981443 |
Other study ID # | BrowPtosis |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 15, 2023 |
Est. completion date | June 2024 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Cody Blanchard |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Complication Rates | Complication rates of both Dermabond and non-absorbable sutures to include dehiscence and infection | 6 weeks |
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