Shoulder Arthritis, Surgical Incision, Surgical Wound
Conditions
Brief summary
This is a research study to find out whether wound closure (the process of closing the surgical wound after the procedure is complete) with Dermabond PRINEO Skin Closure System (PRINEO) will be faster and improve wound healing compared to standard closing methods after total shoulder replacement. The PRINEO system involves using running stitches to close the wound, and then taping over the sutures with a sticky film that holds the wound closed.
Interventions
PROCEDURESubcuticular Sutures - Surgeon 1
This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
PROCEDUREMetal Staples - Surgeon 2
This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
DEVICEPRINEO - Surgeon 1
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.
DEVICEPRINEO - Surgeon 2
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.
Sponsors
Johnson & Johnson
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects will be included if: * They are 18 years or older; * They are undergoing primary total shoulder arthroplasty by the principal and co-investigator. * They are willing and have the capacity to provide informed consent; * They expect to continue their post-operative follow up care with their operating surgeons at Medical University of South Carolina (MUSC). Subjects will be excluded if: * They have a unique, identifying tattoo or skin marking within 2 inches of intended site of surgical incision * They self-report a known hypersensitivity to cyanoacrylate, formaldehyde, benzalkonium chloride, or pressure sensitive adhesive; * They self-report or have a documented prior ipsilateral shoulder arthroplasty or other open ipsilateral shoulder surgery utilizing the delto-pectoral approach; * Their medical record shows that they are HIV positive or otherwise immunocompromised; * Their medical record shows a skin abnormality or dermatological condition which affects skin healing; * They report a personal or family history of significant keloid or significant hypertrophic scar formations, or other problems with wound healing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls | 3 months post-operatively | Patient satisfaction ratings were on a scale from 0-10, where 0 = very dissatisfied and 10 = very satisfied. |
| Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control. | 3 months post-operative | 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. |
| Mean Closure Time Per Centimeter of Incision | Immediate/at time of surgery | This 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Cosmesis (MHCS) Score by Operating Physician | Up to 3 months post surgery | 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. |
| Differences Between Patient and Surgeon Total POSAS Scores | 3 months post-operatively | 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. |
| Median Overall Opinion Score Reported by Operating Surgeon | Up to 3 months | 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. |
| Median Scar Assessment (POSAS) by Plastic Surgeon | Up to 3 months post surgery | 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. |
| Wound Cosmesis (MHCS) Score by Plastic Surgeon | Up to 3 months post surgery | 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. |
| Median Overall Opinion Score Reported by Plastic Surgeons | Up to 3 months | 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. |
| Median Wound Inflammation Score (AIRE) Reported by Operating Physician | Up to 3 months post surgery | 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. |
| Median Scar Assessment (POSAS) by Operating Surgeon | Up to 3 months post surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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, | 22 |
| 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. | 25 |
| 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. | 21 |
| Total | 89 |
Baseline characteristics
| Characteristic | Traditional Dermabond + Subcuticular Sutures - Surgeon 1 | Metal Staples - Surgeon 2 | Dermabond PRINEO - Surgeon 1 | Dermabond PRINEO - Surgeon 2 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 15 Participants | 18 Participants | 13 Participants | 63 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 7 Participants | 7 Participants | 8 Participants | 26 Participants |
| Number of Participants Who Currently Smoke | 0 Participants | 2 Participants | 4 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 18 Participants | 24 Participants | 20 Participants | 83 Participants |
| Region of Enrollment United States | 21 participants | 22 participants | 25 participants | 21 participants | 89 participants |
| Sex: Female, Male Female | 13 Participants | 11 Participants | 12 Participants | 15 Participants | 51 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 13 Participants | 6 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 22 | 0 / 46 |
| other Total, other adverse events | 0 / 21 | 0 / 22 | 0 / 46 |
| serious Total, serious adverse events | 1 / 21 | 0 / 22 | 1 / 46 |
Outcome results
Primary
Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls
Patient satisfaction ratings were on a scale from 0-10, where 0 = very dissatisfied and 10 = very satisfied.
Time frame: 3 months post-operatively
Population: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traditional Dermabond + Subcuticular Sutures - Surgeon 1 | Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls | 10 score on a scale |
| Metal Staples - Surgeon 2 | Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls | 10 score on a scale |
| Dermabond PRINEO - Surgeon 1 | Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls | 10 score on a scale |
| Dermabond PRINEO - Surgeon 2 | Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls | 10 score on a scale |
Primary
Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control.
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.
Time frame: 3 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Dermabond + Subcuticular Sutures - Surgeon 1 | Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control. | 627.83 Dollars | Standard Deviation 90.22 |
| Metal Staples - Surgeon 2 | Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control. | 304.75 Dollars | Standard Deviation 45.3 |
| Dermabond PRINEO - Surgeon 1 | Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control. | 568.53 Dollars | Standard Deviation 88.98 |
| Dermabond PRINEO - Surgeon 2 | Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control. | 420.77 Dollars | Standard Deviation 51.99 |
Primary
Mean Closure Time Per Centimeter of Incision
This 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.
Time frame: Immediate/at time of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Dermabond + Subcuticular Sutures - Surgeon 1 | Mean Closure Time Per Centimeter of Incision | 1.3 minutes/centimeters | Standard Error 0.05 |
| Metal Staples - Surgeon 2 | Mean Closure Time Per Centimeter of Incision | 0.65 minutes/centimeters | Standard Error 0.02 |
| Dermabond PRINEO - Surgeon 1 | Mean Closure Time Per Centimeter of Incision | 1.1 minutes/centimeters | Standard Error 0.04 |
| Dermabond PRINEO - Surgeon 2 | Mean Closure Time Per Centimeter of Incision | 0.72 minutes/centimeters | Standard Error 0.03 |
Secondary
Differences Between Patient and Surgeon Total POSAS Scores
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.
Time frame: 3 months post-operatively
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traditional Dermabond + Subcuticular Sutures - Surgeon 1 | Differences Between Patient and Surgeon Total POSAS Scores | 11.5 units on a scale |
| Metal Staples - Surgeon 2 | Differences Between Patient and Surgeon Total POSAS Scores | 9 units on a scale |
| Dermabond PRINEO - Surgeon 1 | Differences Between Patient and Surgeon Total POSAS Scores | 7 units on a scale |
| Dermabond PRINEO - Surgeon 2 | Differences Between Patient and Surgeon Total POSAS Scores | 6 units on a scale |
| Dermabond PRINEO - Surgeon 1 Patient Scores | Differences Between Patient and Surgeon Total POSAS Scores | 13 units on a scale |
| Dermabond PRINEO - Surgeon 1 Scores | Differences Between Patient and Surgeon Total POSAS Scores | 10 units on a scale |
| Dermabond PRINEO - Surgeon 2 Patient Scores | Differences Between Patient and Surgeon Total POSAS Scores | 9 units on a scale |
| Dermabond PRINEO - Surgeon 2 Scores | Differences Between Patient and Surgeon Total POSAS Scores | 6 units on a scale |
p-value: 0.896Wilcoxon (Mann-Whitney)
p-value: 0.612Wilcoxon (Mann-Whitney)
Secondary
Median Overall Opinion Score Reported by Operating Surgeon
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.
Time frame: Up to 3 months
Population: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traditional Dermabond + Subcuticular Sutures - Surgeon 1 | Median Overall Opinion Score Reported by Operating Surgeon | 2 score on a scale |
| Metal Staples - Surgeon 2 | Median Overall Opinion Score Reported by Operating Surgeon | 1 score on a scale |
| Dermabond PRINEO - Surgeon 1 | Median Overall Opinion Score Reported by Operating Surgeon | 2 score on a scale |
| Dermabond PRINEO - Surgeon 2 | Median Overall Opinion Score Reported by Operating Surgeon | 1 score on a scale |
Secondary
Median Overall Opinion Score Reported by Plastic Surgeons
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.
Time frame: Up to 3 months
Population: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traditional Dermabond + Subcuticular Sutures - Surgeon 1 | Median Overall Opinion Score Reported by Plastic Surgeons | 5 score on a scale |
| Metal Staples - Surgeon 2 | Median Overall Opinion Score Reported by Plastic Surgeons | 3 score on a scale |
| Dermabond PRINEO - Surgeon 1 | Median Overall Opinion Score Reported by Plastic Surgeons | 5 score on a scale |
| Dermabond PRINEO - Surgeon 2 | Median Overall Opinion Score Reported by Plastic Surgeons | 4 score on a scale |
Secondary
Median Scar Assessment (POSAS) by Operating Surgeon
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.
Time frame: Up to 3 months post surgery
Population: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traditional Dermabond + Subcuticular Sutures - Surgeon 1 | Median Scar Assessment (POSAS) by Operating Surgeon | 9 score on a scale |
| Metal Staples - Surgeon 2 | Median Scar Assessment (POSAS) by Operating Surgeon | 6 score on a scale |
| Dermabond PRINEO - Surgeon 1 | Median Scar Assessment (POSAS) by Operating Surgeon | 10 score on a scale |
| Dermabond PRINEO - Surgeon 2 | Median Scar Assessment (POSAS) by Operating Surgeon | 6 score on a scale |
Secondary
Median Scar Assessment (POSAS) by Plastic Surgeon
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.
Time frame: Up to 3 months post surgery
Population: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traditional Dermabond + Subcuticular Sutures - Surgeon 1 | Median Scar Assessment (POSAS) by Plastic Surgeon | 25 score on a scale |
| Metal Staples - Surgeon 2 | Median Scar Assessment (POSAS) by Plastic Surgeon | 18 score on a scale |
| Dermabond PRINEO - Surgeon 1 | Median Scar Assessment (POSAS) by Plastic Surgeon | 25 score on a scale |
| Dermabond PRINEO - Surgeon 2 | Median Scar Assessment (POSAS) by Plastic Surgeon | 20.5 score on a scale |
Secondary
Median Wound Inflammation Score (AIRE) Reported by Operating Physician
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.
Time frame: Up to 3 months post surgery
Population: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traditional Dermabond + Subcuticular Sutures - Surgeon 1 | Median Wound Inflammation Score (AIRE) Reported by Operating Physician | 0 score on a scale |
| Metal Staples - Surgeon 2 | Median Wound Inflammation Score (AIRE) Reported by Operating Physician | 0 score on a scale |
| Dermabond PRINEO - Surgeon 1 | Median Wound Inflammation Score (AIRE) Reported by Operating Physician | 0.5 score on a scale |
| Dermabond PRINEO - Surgeon 2 | Median Wound Inflammation Score (AIRE) Reported by Operating Physician | 0 score on a scale |
Secondary
Wound Cosmesis (MHCS) Score by Operating Physician
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.
Time frame: Up to 3 months post surgery
Population: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traditional Dermabond + Subcuticular Sutures - Surgeon 1 | Wound Cosmesis (MHCS) Score by Operating Physician | 2 score on a scale |
| Metal Staples - Surgeon 2 | Wound Cosmesis (MHCS) Score by Operating Physician | 1 score on a scale |
| Dermabond PRINEO - Surgeon 1 | Wound Cosmesis (MHCS) Score by Operating Physician | 3 score on a scale |
| Dermabond PRINEO - Surgeon 2 | Wound Cosmesis (MHCS) Score by Operating Physician | 1 score on a scale |
Secondary
Wound Cosmesis (MHCS) Score by Plastic Surgeon
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.
Time frame: Up to 3 months post surgery
Population: Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traditional Dermabond + Subcuticular Sutures - Surgeon 1 | Wound Cosmesis (MHCS) Score by Plastic Surgeon | 2 score on a scale |
| Metal Staples - Surgeon 2 | Wound Cosmesis (MHCS) Score by Plastic Surgeon | 1 score on a scale |
| Dermabond PRINEO - Surgeon 1 | Wound Cosmesis (MHCS) Score by Plastic Surgeon | 3 score on a scale |
| Dermabond PRINEO - Surgeon 2 | Wound Cosmesis (MHCS) Score by Plastic Surgeon | 1 score on a scale |