Brow PtosisNCT05981443
An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures
A study testing Dermabond and Non-Absorbable Sutures in people with Brow Ptosis and Surgical Wound, run by Cody Blanchard at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Brow Ptosis, Surgical Wound
- What is being tested?
- Dermabond and Non-Absorbable Sutures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 17 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients <18 years of age or >100
- Allergy to Dermabond
- Adults with impaired consent capacity
- Incarcerated individuals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scar Analysis in Direct Excision Brow Lift: Comparing Octyl-2- Cyanoacrylate (Dermabond) Versus Non-absorbable Sutures
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
- Being tested
- Dermabond, Non-Absorbable Sutures
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermabondDevice
Use of Dermabond to close surgical incisions instead of non-absorbable sutures
Non-Absorbable SuturesOther
Use of conventional non-absorbable sutures to close surgical incisions
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Dermabond | Experimental | The surgical wound over one eyebrow will be closed with Dermabond. Receives: Device: Dermabond |
| Active Comparator: Non-Absorbable Sutures | Active comparator | The surgical wound over one eyebrow will be closed with non-absorbable sutures. Receives: Other: Non-Absorbable Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Number of Participants With Complications
Complications of both Dermabond and non-absorbable sutures to include dehiscence and infection
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start15 Aug 2023
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brow PtosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cody Blanchard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cody Blanchard, University of Kentucky
- Investigators
- Peter Timoney, MD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981443
- Sponsor's protocol ID
- BrowPtosis
- Status last verified
- Apr 2025
- First submitted
- 31 Jul 2023
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scar Analysis in Direct Excision Brow Lift: Comparing Octyl-2- Cyanoacrylate (Dermabond) Versus Non-absorbable Sutures
- ClinicalTrials.gov ID
- NCT05981443
- Acronym / sponsor ID
- BrowPtosis
- Conditions
- Brow Ptosis, Surgical Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cody BlanchardUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Posted 24 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Dermabond | Experimental | Device: DermabondThe surgical wound over one eyebrow will be closed with Dermabond. |
| Active Comparator: Non-Absorbable Sutures | Active comparator | Other: Non-Absorbable SuturesThe surgical wound over one eyebrow will be closed with non-absorbable sutures. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients <18 years of age or >100
- Allergy to Dermabond
- Adults with impaired consent capacity
- Incarcerated individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermabondUse of Dermabond to close surgical incisions instead of non-absorbable sutures | Device | Active Comparator: Dermabond |
| Non-Absorbable SuturesUse of conventional non-absorbable sutures to close surgical incisions | Other | Active Comparator: Non-Absorbable Sutures |
Primary outcome
Scar Appearance
Time frame: 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.
Scar Appearance
Time frame: 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.
Number of Participants With Complications
Time frame: 6 weeks
Complications of both Dermabond and non-absorbable sutures to include dehiscence and infection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Brow Ptosis
Not yet recruiting
Enhancing the Durability of Thread-Assisted Brow Suspension Through Upper Blepharoplasty-Assisted Ligament Release
Brow Ptosis, Dermatochalasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Timoney, MD study director
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermabond and Non-Absorbable Sutures in people with Brow Ptosis and Surgical Wound, run by Cody Blanchard at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Appearance (time frame: 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.