Surgical WoundNCT03860181
Dermabond PRINEO for Total Shoulder Arthroplasty
A study testing Subcuticular Sutures - Surgeon 1, Metal Staples - Surgeon 2 and PRINEO - Surgeon 1 in people with Surgical Wound and Shoulder Arthritis, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound, Shoulder Arthritis, Surgical Incision
- What is being tested?
- Subcuticular Sutures - Surgeon 1, Metal Staples - Surgeon 2 and PRINEO - Surgeon 1
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 23 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder Arthroplasty: A Randomized, Controlled Trial
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.
- Conditions
- Surgical Wound, Shoulder Arthritis, Surgical Incision
- Being tested
- Subcuticular Sutures - Surgeon 1, Metal Staples - Surgeon 2, PRINEO - Surgeon 1, PRINEO - Surgeon 2
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcuticular Sutures - Surgeon 1Procedure or surgery
This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
Metal Staples - Surgeon 2Procedure or surgery
This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
PRINEO - Surgeon 1Device
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 2Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Dermabond + subcuticular sutures - Surgeon 1 | Active comparator | Subcuticular sutures with traditional Dermabond applied to incision. Receives: Procedure: Subcuticular Sutures - Surgeon 1 |
| Metal staples - Surgeon 2 | Active comparator | Metal staples Receives: Procedure: Metal Staples - Surgeon 2 |
| Dermabond PRINEO - Surgeon 1 | Experimental | Dermabond PRINEO System Receives: Device: PRINEO - Surgeon 1 |
| Dermabond PRINEO - Surgeon 2 | Experimental | Dermabond PRINEO System Receives: Device: PRINEO - Surgeon 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Immediate/at time of surgery
Secondary outcomes (8)
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.
Measured: Up to 3 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start25 Mar 2019
- Primary completion23 Jun 2020
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Josef Eichinger, Medical University of South Carolina
- Investigators
- Josef Eichinger, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860181
- Sponsor's protocol ID
- 00084714
- Status last verified
- Sep 2021
- First submitted
- 27 Feb 2019
- Last updated
- 1 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder Arthroplasty: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03860181
- Acronym / sponsor ID
- 00084714
- Conditions
- Surgical Wound, Shoulder Arthritis, Surgical Incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Posted 25 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Traditional Dermabond + subcuticular sutures - Surgeon 1 | Active comparator | Procedure: Subcuticular Sutures - Surgeon 1Subcuticular sutures with traditional Dermabond applied to incision. |
| Metal staples - Surgeon 2 | Active comparator | Procedure: Metal Staples - Surgeon 2Metal staples |
| Dermabond PRINEO - Surgeon 1 | Experimental | Device: PRINEO - Surgeon 1Dermabond PRINEO System |
| Dermabond PRINEO - Surgeon 2 | Experimental | Device: PRINEO - Surgeon 2Dermabond PRINEO System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcuticular Sutures - Surgeon 1This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures. | Procedure or surgery | Traditional Dermabond + subcuticular sutures - Surgeon 1 |
| Metal Staples - Surgeon 2This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures, | Procedure or surgery | Metal staples - Surgeon 2 |
| PRINEO - Surgeon 1The 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. | Device | Dermabond PRINEO - Surgeon 1 |
| PRINEO - Surgeon 2The 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. | Device | Dermabond PRINEO - Surgeon 2 |
Primary outcome
Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control.
Time frame: 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.
Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls
Time frame: 3 months post-operatively
Patient satisfaction ratings were on a scale from 0-10, where 0 = very dissatisfied and 10 = very satisfied.
Mean Closure Time Per Centimeter of Incision
Time frame: 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.
8 secondary outcomes
Median Overall Opinion Score Reported by Operating Surgeon
Time frame: Up to 3 months
Median Wound Inflammation Score (AIRE) Reported by Operating Physician
Time frame: Up to 3 months post surgery
Median Scar Assessment (POSAS) by Operating Surgeon
Time frame: Up to 3 months post surgery
Wound Cosmesis (MHCS) Score by Operating Physician
Time frame: Up to 3 months post surgery
Differences Between Patient and Surgeon Total POSAS Scores
Time frame: 3 months post-operatively
Median Overall Opinion Score Reported by Plastic Surgeons
Time frame: Up to 3 months
Median Scar Assessment (POSAS) by Plastic Surgeon
Time frame: Up to 3 months post surgery
Wound Cosmesis (MHCS) Score by Plastic Surgeon
Time frame: Up to 3 months post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Eichinger, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcuticular Sutures - Surgeon 1, Metal Staples - Surgeon 2 and PRINEO - Surgeon 1 in people with Surgical Wound and Shoulder Arthritis, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control. (time frame: 3 months post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.