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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Dermabond + subcuticular sutures - Surgeon 1 | Active Comparator | Subcuticular sutures with traditional Dermabond applied to incision. |
|
| Metal staples - Surgeon 2 | Active Comparator | Metal staples |
|
| Dermabond PRINEO - Surgeon 1 | Experimental | Dermabond PRINEO System |
|
| Dermabond PRINEO - Surgeon 2 | Experimental | Dermabond PRINEO System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcuticular Sutures - Surgeon 1 | Procedure | This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months post-operative |
| 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. | 3 months post-operatively |
| 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. | Immediate/at time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 months |
| Median Wound Inflammation Score (AIRE) Reported by Operating Physician |
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Subjects will be included if:
Subjects will be excluded if:
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| Name | Affiliation | Role |
|---|---|---|
| Josef Eichinger, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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, |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Dollars | 3 months post-operative |
|
The adverse even data was collected up to 3 months post-operatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Traditional Dermabond + Subcuticular Sutures | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josef Eichinger, MD | Medical University of South Carolina | 843-876-0111 | eichinge@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2019 | Jun 17, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 25, 2019 | Jun 17, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Metal Staples - Surgeon 2 | Procedure | This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures, |
|
| PRINEO - Surgeon 1 | Device | 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. |
|
| PRINEO - Surgeon 2 | Device | 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. |
|
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. |
| Up to 3 months post surgery |
| 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. | Up to 3 months post surgery |
| 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. | Up to 3 months post surgery |
| 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. | 3 months post-operatively |
| 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. | Up to 3 months |
| 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. | Up to 3 months post surgery |
| 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. | Up to 3 months post surgery |
| 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, |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Participants Who Currently Smoke | Patients who self-reported their smoking status as "Yes" at baseline. | Count of Participants | Participants |
|
Metal staples Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures, |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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. | Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected. | Posted | Median | Full Range | score on a scale | 3 months post-operatively |
|
|
|
| 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. | Posted | Mean | Standard Error | minutes/centimeters | Immediate/at time of surgery |
|
|
|
| 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. | Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected. | Posted | Median | Full Range | score on a scale | Up to 3 months |
|
|
|
| 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. | Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected. | Posted | Median | Full Range | score on a scale | Up to 3 months post surgery |
|
|
|
| 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. | Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected. | Posted | Median | Full Range | score on a scale | Up to 3 months post surgery |
|
|
|
| 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. | Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected. | Posted | Median | Full Range | score on a scale | Up to 3 months post surgery |
|
|
|
| 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. | 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. | Posted | Median | Full Range | units on a scale | 3 months post-operatively |
|
|
|
|
| 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. | Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected. | Posted | Median | Full Range | score on a scale | Up to 3 months |
|
|
|
| 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. | Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected. | Posted | Median | Full Range | score on a scale | Up to 3 months post surgery |
|
|
|
| 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. | Participants who had adverse events before the conclusion of the study were excluded from this analysis, because outcome measures could not be collected. | Posted | Median | Full Range | score on a scale | Up to 3 months post surgery |
|
|
|
| 0 |
| 21 |
| 1 |
| 21 |
| 0 |
| 21 |
| EG001 | Metal Staples | Metal staples Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures, | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Dermabond PRINEO | 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. | 0 | 46 | 1 | 46 | 0 | 46 |
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| Wilcoxon (Mann-Whitney) |
Mann-Whitney U = 210 |
| 0.612 |
| Equivalence |
The statistical significance's p-value was set at 0.05. For Surgeon 2's differences, they were calculated as patient POSAS score - surgeon 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. |