Trial Outcomes & Findings for An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures (NCT NCT05981443)
NCT ID: NCT05981443
Last Updated: 2025-04-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
10 days
Results posted on
2025-04-24
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures
Baseline characteristics by cohort
| Measure |
Active Comparator: Dermabond
n=3 Participants
The surgical wound over one eyebrow will be closed with Dermabond.
Dermabond: Use of Dermabond to close surgical incisions instead of non-absorbable sutures
|
Active Comparator: Non-Absorbable Sutures
n=3 Participants
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
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 2 • n=5 Participants
|
77 years
STANDARD_DEVIATION 3.7 • n=7 Participants
|
73 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 daysPatient 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.
Outcome measures
| Measure |
Active Comparator: Dermabond
n=3 Participants
The surgical wound over one eyebrow will be closed with Dermabond.
Dermabond: Use of Dermabond to close surgical incisions instead of non-absorbable sutures
|
Active Comparator: Non-Absorbable Sutures
n=3 Participants
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
|
|---|---|---|
|
Scar Appearance
|
7 score on a scale
Interval 5.0 to 9.0
|
2.33 score on a scale
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: 6 weeksPatient 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.
Outcome measures
| Measure |
Active Comparator: Dermabond
n=3 Participants
The surgical wound over one eyebrow will be closed with Dermabond.
Dermabond: Use of Dermabond to close surgical incisions instead of non-absorbable sutures
|
Active Comparator: Non-Absorbable Sutures
n=3 Participants
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
|
|---|---|---|
|
Scar Appearance
|
2 score on a scale
Interval 1.0 to 3.0
|
4 score on a scale
Interval 3.0 to 5.0
|
PRIMARY outcome
Timeframe: 6 weeksComplications of both Dermabond and non-absorbable sutures to include dehiscence and infection
Outcome measures
| Measure |
Active Comparator: Dermabond
n=3 Participants
The surgical wound over one eyebrow will be closed with Dermabond.
Dermabond: Use of Dermabond to close surgical incisions instead of non-absorbable sutures
|
Active Comparator: Non-Absorbable Sutures
n=3 Participants
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
|
|---|---|---|
|
Number of Participants With Complications
|
0 participants
|
0 participants
|
Adverse Events
Active Comparator: Dermabond
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator: Non-Absorbable Sutures
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place