Trial Outcomes & Findings for Dermabond PRINEO for Total Shoulder Arthroplasty (NCT NCT03860181)
NCT ID: NCT03860181
Last Updated: 2021-10-01
Results Overview
Closure cost was calculated by evaluating the cost of wound closure products ($) per patient, plus the cost of the operating room ($) per minute, multiplied by the closure time (minutes) per centimeter of incision length, then multiplied by the average incision length (cm) per patient.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
3 months post-operative
Results posted on
2021-10-01
Participant Flow
Participant milestones
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
25
|
21
|
|
Overall Study
COMPLETED
|
21
|
22
|
25
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dermabond PRINEO for Total Shoulder Arthroplasty
Baseline characteristics by cohort
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
n=21 Participants
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
n=22 Participants
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
n=25 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
n=21 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
25 participants
n=5 Participants
|
21 participants
n=4 Participants
|
89 participants
n=21 Participants
|
|
Number of Participants Who Currently Smoke
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 months post-operativeClosure cost was calculated by evaluating the cost of wound closure products ($) per patient, plus the cost of the operating room ($) per minute, multiplied by the closure time (minutes) per centimeter of incision length, then multiplied by the average incision length (cm) per patient.
Outcome measures
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
n=21 Participants
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
n=22 Participants
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
n=25 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
n=21 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Patient Scores
Patients that received the Dermabond PRINEO System intervention for wound closure from Surgeon 1.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Scores
Surgeon 1 Scores for patients that received the Dermabond PRINEO closure system.
|
Dermabond PRINEO - Surgeon 2 Patient Scores
Patients that received the Dermabond PRINEO System intervention wound closure from Surgeon 2.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2 Scores
Surgeon 2 Scores for patients that received the Dermabond PRINEO closure system.
|
|---|---|---|---|---|---|---|---|---|
|
Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control.
|
627.83 Dollars
Standard Deviation 90.22
|
304.75 Dollars
Standard Deviation 45.30
|
568.53 Dollars
Standard Deviation 88.98
|
420.77 Dollars
Standard Deviation 51.99
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 months post-operativelyPopulation: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
Patient satisfaction ratings were on a scale from 0-10, where 0 = very dissatisfied and 10 = very satisfied.
Outcome measures
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
n=20 Participants
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
n=22 Participants
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
n=22 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
n=21 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Patient Scores
Patients that received the Dermabond PRINEO System intervention for wound closure from Surgeon 1.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Scores
Surgeon 1 Scores for patients that received the Dermabond PRINEO closure system.
|
Dermabond PRINEO - Surgeon 2 Patient Scores
Patients that received the Dermabond PRINEO System intervention wound closure from Surgeon 2.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2 Scores
Surgeon 2 Scores for patients that received the Dermabond PRINEO closure system.
|
|---|---|---|---|---|---|---|---|---|
|
Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls
|
10 score on a scale
Interval 0.0 to 10.0
|
10 score on a scale
Interval 0.0 to 10.0
|
10 score on a scale
Interval 0.0 to 10.0
|
10 score on a scale
Interval 0.0 to 10.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Immediate/at time of surgeryThis closure time was measured from the first stitch for closure to the application of the wound dressing. The incision length was measured immediately after closure.
Outcome measures
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
n=21 Participants
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
n=22 Participants
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
n=25 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
n=21 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Patient Scores
Patients that received the Dermabond PRINEO System intervention for wound closure from Surgeon 1.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Scores
Surgeon 1 Scores for patients that received the Dermabond PRINEO closure system.
|
Dermabond PRINEO - Surgeon 2 Patient Scores
Patients that received the Dermabond PRINEO System intervention wound closure from Surgeon 2.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2 Scores
Surgeon 2 Scores for patients that received the Dermabond PRINEO closure system.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Closure Time Per Centimeter of Incision
|
1.3 minutes/centimeters
Standard Error 0.05
|
0.65 minutes/centimeters
Standard Error 0.02
|
1.1 minutes/centimeters
Standard Error 0.04
|
0.72 minutes/centimeters
Standard Error 0.03
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
Overall Opinion was on a scale 1 - 10, where lower scores are viewed more favorably with 1=normal skin and 10=very different compared to adjacent skin, which was evaluated by the operating physician.
Outcome measures
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
n=20 Participants
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
n=22 Participants
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
n=22 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
n=21 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Patient Scores
Patients that received the Dermabond PRINEO System intervention for wound closure from Surgeon 1.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Scores
Surgeon 1 Scores for patients that received the Dermabond PRINEO closure system.
|
Dermabond PRINEO - Surgeon 2 Patient Scores
Patients that received the Dermabond PRINEO System intervention wound closure from Surgeon 2.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2 Scores
Surgeon 2 Scores for patients that received the Dermabond PRINEO closure system.
|
|---|---|---|---|---|---|---|---|---|
|
Median Overall Opinion Score Reported by Operating Surgeon
|
2 score on a scale
Interval 1.0 to 10.0
|
1 score on a scale
Interval 1.0 to 10.0
|
2 score on a scale
Interval 1.0 to 10.0
|
1 score on a scale
Interval 1.0 to 10.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months post surgeryPopulation: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
Images of the healing wound will be assessed according to the Acute Inflammatory Response Evaluation score (0 to 3, 0 being the lowest amount of inflammation and 3 represents the highest amount of inflammation) by the operating physician.
Outcome measures
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
n=20 Participants
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
n=22 Participants
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
n=22 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
n=21 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Patient Scores
Patients that received the Dermabond PRINEO System intervention for wound closure from Surgeon 1.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Scores
Surgeon 1 Scores for patients that received the Dermabond PRINEO closure system.
|
Dermabond PRINEO - Surgeon 2 Patient Scores
Patients that received the Dermabond PRINEO System intervention wound closure from Surgeon 2.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2 Scores
Surgeon 2 Scores for patients that received the Dermabond PRINEO closure system.
|
|---|---|---|---|---|---|---|---|---|
|
Median Wound Inflammation Score (AIRE) Reported by Operating Physician
|
0 score on a scale
Interval 0.0 to 12.0
|
0 score on a scale
Interval 0.0 to 12.0
|
0.5 score on a scale
Interval 0.0 to 12.0
|
0 score on a scale
Interval 0.0 to 12.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months post surgeryPopulation: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
Images of the healing wound will be assessed according to the Patient and Observer Scar Assessment Scale (POSAS, where there are six components each ranging between 1-10 with 10 representing the worst outcome, and each of those six components were summed for these results, having a final range of 6-60) by the operating surgeon.
Outcome measures
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
n=20 Participants
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
n=22 Participants
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
n=22 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
n=21 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Patient Scores
Patients that received the Dermabond PRINEO System intervention for wound closure from Surgeon 1.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Scores
Surgeon 1 Scores for patients that received the Dermabond PRINEO closure system.
|
Dermabond PRINEO - Surgeon 2 Patient Scores
Patients that received the Dermabond PRINEO System intervention wound closure from Surgeon 2.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2 Scores
Surgeon 2 Scores for patients that received the Dermabond PRINEO closure system.
|
|---|---|---|---|---|---|---|---|---|
|
Median Scar Assessment (POSAS) by Operating Surgeon
|
9 score on a scale
Interval 6.0 to 60.0
|
6 score on a scale
Interval 6.0 to 60.0
|
10 score on a scale
Interval 6.0 to 60.0
|
6 score on a scale
Interval 6.0 to 60.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months post surgeryPopulation: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
Evaluation of the wound after surgery will be assessed according to the Modified Hollander Cosmesis Scale (0 to 6, with 0 being ideal) by the operating physician.
Outcome measures
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
n=20 Participants
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
n=22 Participants
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
n=22 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
n=21 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Patient Scores
Patients that received the Dermabond PRINEO System intervention for wound closure from Surgeon 1.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Scores
Surgeon 1 Scores for patients that received the Dermabond PRINEO closure system.
|
Dermabond PRINEO - Surgeon 2 Patient Scores
Patients that received the Dermabond PRINEO System intervention wound closure from Surgeon 2.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2 Scores
Surgeon 2 Scores for patients that received the Dermabond PRINEO closure system.
|
|---|---|---|---|---|---|---|---|---|
|
Wound Cosmesis (MHCS) Score by Operating Physician
|
2 score on a scale
Interval 0.0 to 6.0
|
1 score on a scale
Interval 0.0 to 6.0
|
3 score on a scale
Interval 0.0 to 6.0
|
1 score on a scale
Interval 0.0 to 6.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months post-operativelyPopulation: Arms were regrouped to reflect the patient and surgeon scores for each intervention. Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
POSAS scores can range from 1-10, where 1 is like normal skin, and 10 is worst scar imaginable, and has six components. Each component (range of 1-10) was summed up to get a final score (range of 6-60) for each participant. Differences were calculated as the participant's Patient and Observer Scar Assessment Scale (POSAS) score minus the physician POSAS score, with a negative difference signifying that the patients thought more highly of the scars than the physicians since lower POSAS scores are more favorable.
Outcome measures
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
n=20 Participants
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
n=20 Participants
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
n=22 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
n=22 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Patient Scores
n=22 Participants
Patients that received the Dermabond PRINEO System intervention for wound closure from Surgeon 1.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Scores
n=22 Participants
Surgeon 1 Scores for patients that received the Dermabond PRINEO closure system.
|
Dermabond PRINEO - Surgeon 2 Patient Scores
n=21 Participants
Patients that received the Dermabond PRINEO System intervention wound closure from Surgeon 2.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2 Scores
n=21 Participants
Surgeon 2 Scores for patients that received the Dermabond PRINEO closure system.
|
|---|---|---|---|---|---|---|---|---|
|
Differences Between Patient and Surgeon Total POSAS Scores
|
11.5 units on a scale
Interval 6.0 to 60.0
|
9 units on a scale
Interval 6.0 to 60.0
|
7 units on a scale
Interval 6.0 to 60.0
|
6 units on a scale
Interval 6.0 to 60.0
|
13 units on a scale
Interval 6.0 to 60.0
|
10 units on a scale
Interval 6.0 to 60.0
|
9 units on a scale
Interval 6.0 to 60.0
|
6 units on a scale
Interval 6.0 to 60.0
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
Overall Opinion was on a scale 1 - 10, where lower scores are viewed more favorably with 1=normal skin and 10=very different compared to adjacent skin, which was evaluated by an independent plastic surgeon.
Outcome measures
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
n=19 Participants
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
n=22 Participants
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
n=21 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
n=20 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Patient Scores
Patients that received the Dermabond PRINEO System intervention for wound closure from Surgeon 1.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Scores
Surgeon 1 Scores for patients that received the Dermabond PRINEO closure system.
|
Dermabond PRINEO - Surgeon 2 Patient Scores
Patients that received the Dermabond PRINEO System intervention wound closure from Surgeon 2.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2 Scores
Surgeon 2 Scores for patients that received the Dermabond PRINEO closure system.
|
|---|---|---|---|---|---|---|---|---|
|
Median Overall Opinion Score Reported by Plastic Surgeons
|
5 score on a scale
Interval 1.0 to 10.0
|
3 score on a scale
Interval 1.0 to 10.0
|
5 score on a scale
Interval 1.0 to 10.0
|
4 score on a scale
Interval 1.0 to 10.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months post surgeryPopulation: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
Images of the healing wound will be assessed according to the Patient and Observer Scar Assessment Scale (POSAS, includes six measurements ranging from 0 to 10, 10 being ideal, where the total of the six measurements is what is reported) by an independent plastic surgeon. This POSAS total score would then range from 6-60.
Outcome measures
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
n=19 Participants
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
n=22 Participants
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
n=21 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
n=20 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Patient Scores
Patients that received the Dermabond PRINEO System intervention for wound closure from Surgeon 1.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Scores
Surgeon 1 Scores for patients that received the Dermabond PRINEO closure system.
|
Dermabond PRINEO - Surgeon 2 Patient Scores
Patients that received the Dermabond PRINEO System intervention wound closure from Surgeon 2.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2 Scores
Surgeon 2 Scores for patients that received the Dermabond PRINEO closure system.
|
|---|---|---|---|---|---|---|---|---|
|
Median Scar Assessment (POSAS) by Plastic Surgeon
|
25 score on a scale
Interval 6.0 to 60.0
|
18 score on a scale
Interval 6.0 to 60.0
|
25 score on a scale
Interval 6.0 to 60.0
|
20.5 score on a scale
Interval 6.0 to 60.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months post surgeryPopulation: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
Evaluation of the wound after surgery will be assessed according to the Modified Hollander Cosmesis Scale (0 to 6, with 0 being ideal) by an independent plastic surgeon.
Outcome measures
| Measure |
Traditional Dermabond + Subcuticular Sutures - Surgeon 1
n=19 Participants
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples - Surgeon 2
n=22 Participants
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO - Surgeon 1
n=21 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2
n=20 Participants
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Patient Scores
Patients that received the Dermabond PRINEO System intervention for wound closure from Surgeon 1.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 1 Scores
Surgeon 1 Scores for patients that received the Dermabond PRINEO closure system.
|
Dermabond PRINEO - Surgeon 2 Patient Scores
Patients that received the Dermabond PRINEO System intervention wound closure from Surgeon 2.
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
Dermabond PRINEO - Surgeon 2 Scores
Surgeon 2 Scores for patients that received the Dermabond PRINEO closure system.
|
|---|---|---|---|---|---|---|---|---|
|
Wound Cosmesis (MHCS) Score by Plastic Surgeon
|
2 score on a scale
Interval 0.0 to 6.0
|
1 score on a scale
Interval 0.0 to 6.0
|
3 score on a scale
Interval 0.0 to 6.0
|
1 score on a scale
Interval 0.0 to 6.0
|
—
|
—
|
—
|
—
|
Adverse Events
Traditional Dermabond + Subcuticular Sutures
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Metal Staples
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dermabond PRINEO
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Traditional Dermabond + Subcuticular Sutures
n=21 participants at risk
Subcuticular sutures with traditional Dermabond applied to incision.
Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
|
Metal Staples
n=22 participants at risk
Metal staples
Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
|
Dermabond PRINEO
n=46 participants at risk
Dermabond PRINEO System
PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Infection
|
4.8%
1/21 • Number of events 1 • The adverse even data was collected up to 3 months post-operatively.
|
0.00%
0/22 • The adverse even data was collected up to 3 months post-operatively.
|
2.2%
1/46 • Number of events 1 • The adverse even data was collected up to 3 months post-operatively.
|
Other adverse events
Adverse event data not reported
Additional Information
Josef Eichinger, MD
Medical University of South Carolina
Phone: 843-876-0111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place