Brow Ptosis, Surgical Wound
Conditions
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.
Interventions
DEVICEDermabond
Use of Dermabond to close surgical incisions instead of non-absorbable sutures
Use of conventional non-absorbable sutures to close surgical incisions
Sponsors
Cody Blanchard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Participants With Complications | 6 weeks | Complications of both Dermabond and non-absorbable sutures to include dehiscence and infection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Comparator: Dermabond The surgical wound over one eyebrow will be closed with Dermabond.
Dermabond: Use of Dermabond to close surgical incisions instead of non-absorbable sutures | 3 |
| Active Comparator: Non-Absorbable Sutures The surgical wound over one eyebrow will be closed with non-absorbable sutures.
Non-Absorbable Sutures: Use of conventional non-absorbable sutures to close surgical incisions | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | Active Comparator: Dermabond | Total | Active Comparator: Non-Absorbable Sutures |
|---|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 2 | 73 years STANDARD_DEVIATION 5.4 | 77 years STANDARD_DEVIATION 3.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 3 Participants |
| Region of Enrollment United States | 3 participants | 6 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
Number of Participants With Complications
Complications of both Dermabond and non-absorbable sutures to include dehiscence and infection
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Comparator: Dermabond | Number of Participants With Complications | 0 participants |
| Active Comparator: Non-Absorbable Sutures | Number of Participants With Complications | 0 participants |
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.
Time frame: 10 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: Dermabond | Scar Appearance | 7 score on a scale |
| Active Comparator: Non-Absorbable Sutures | Scar Appearance | 2.33 score on a scale |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: Dermabond | Scar Appearance | 2 score on a scale |
| Active Comparator: Non-Absorbable Sutures | Scar Appearance | 4 score on a scale |