Back to resultsAn Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures
Primary Purpose
Brow Ptosis, Surgical Wound
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dermabond
Non-Absorbable Sutures
Sponsored by
About this trial
This is an interventional treatment trial for Brow Ptosis
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
Sites / Locations
- University of KentuckyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active Comparator: Dermabond
Active Comparator: Non-Absorbable Sutures
Arm Description
The surgical wound over one eyebrow will be closed with Dermabond.
The surgical wound over one eyebrow will be closed with non-absorbable sutures.
Outcomes
Primary Outcome Measures
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.
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.
Complication Rates
Complication rates of both Dermabond and non-absorbable sutures to include dehiscence and infection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05981443
Brief Title
An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures
Official Title
Scar Analysis in Direct Excision Brow Lift: Comparing Octyl-2- Cyanoacrylate (Dermabond) Versus Non-absorbable Sutures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cody Blanchard
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brow Ptosis, Surgical Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator: Dermabond
Arm Type
Experimental
Arm Description
The surgical wound over one eyebrow will be closed with Dermabond.
Arm Title
Active Comparator: Non-Absorbable Sutures
Arm Type
Active Comparator
Arm Description
The surgical wound over one eyebrow will be closed with non-absorbable sutures.
Intervention Type
Device
Intervention Name(s)
Dermabond
Intervention Description
Use of Dermabond to close surgical incisions instead of non-absorbable sutures
Intervention Type
Other
Intervention Name(s)
Non-Absorbable Sutures
Intervention Description
Use of conventional non-absorbable sutures to close surgical incisions
Primary Outcome Measure Information:
Title
Scar Appearance
Description
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.
Time Frame
10 days
Title
Scar Appearance
Description
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.
Time Frame
6 weeks
Title
Complication Rates
Description
Complication rates of both Dermabond and non-absorbable sutures to include dehiscence and infection
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cody Blanchard, MD
Phone
859-323-5875
Email
cody.blanchard@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Timoney, MD
Phone
859-323-5875
Email
pjtimo2@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Timoney, MD
Organizational Affiliation
University of Kentucky
Official's Role
Study Director
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Timoney, MD
12. IPD Sharing Statement
Learn more about this trial
An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures
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