Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder Arthroplasty: A Randomized, Controlled Trial
Phase: NA
Conditions: Surgical Wound, Shoulder Arthritis, Surgical Incision
Sponsor: Medical University of South Carolina

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PROTOCOL TITLE: 
Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder 
Arthroplasty: A Randomized, Controlled Trial  
Principal Investigator: Josef K. Eichinger, MD 
1.0 
Objectives/ Specific Aims 
Our study aims to compare the efficacy of a deep-layer, knotless closing method using 
the Dermabond PRINEO skin closure device (2-octyl cyanoacrylate adhesive glue in 
combination with self-adhesive polyester mesh tape) to the current practices of wound 
closure after total joint arthroplasty. While surgeons utilize a variety of incision closure 
techniques, most use a layered closure with deep fascial closure consisting of interrupted, 
knotted sutures combined with either staples (Figure 1) or sutures (Figure 2) for 
superficial closing. In this Phase 4 clinical trial, we hypothesize that the Dermabond 
PRINEO wound closure system with running knotless sutures for deep and superficial 
closure) (Figure 3) will significantly reduce closure time in the operating room and 
achieve similar or better incision healing after shoulder arthroplasty.  
Primary aims: 
1.1 Aim 1: To quantify differences the time required for wound closure with the PRINEO 
closure method (Figure 3) and that of traditional closure methods (interrupted deep 
fascial suture with either subcuticular sutures and traditional Dermabond (Figure 2) or 
metal staples for superficial closure (Figure 1) 
H0: There are no differences in wound closure times between PRINEO and 
subcuticular sutures or metal staples in time to close incisions 
HA: There are differences between PRINEO and subcuticular sutures or metal 
staples in time to close incisions such that staples will be significantly faster than 
PRINEO and PRINEO will be significantly faster than sutures.  
1.2 Aim 2: To quantify differences between PRINEO and subcuticular sutures or metal 
staples in wound healing over three postoperative follow-up points 
H0: There are no differences between PRINEO and subcuticular sutures or metal 
staples in wound healing (dehiscence and drainage) over three postop follow-up 
points.  
HA: There are differences between PRINEO and subcuticular sutures or metal 
staples in wound healing (dehiscence and drainage) over three postop follow-up 
points such that PRINEO demonstrates superior healing to both sutures and 
staples. 
 
 
 
 

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Exploratory Aims:  
1.3 Aim 3: To quantify differences between PRINEO and subcuticular sutures or metal 
staples in observer-evaluated and patient-evaluated cosmetic outcomes for the 
surgical scar over four postoperative follow-up points  
 H0: There are no differences between PRINEO and subcuticular sutures or metal 
staples in cosmetic outcomes over four postop follow-up points.  
 
HA: There are differences between PRINEO and subcuticular sutures or metal 
staples in wound healing (dehiscence and drainage) over four postop follow-up 
points such that PRINEO demonstrates superior cosmetic outcomes to both 
sutures and staples. 
1.4 Aim 4: To quantify differences between PRINEO and subcuticular sutures or metal 
staples in complication rates (defined as allergic reaction, inflammation, irritation, 
drainage, or infection) 
H0: There are no differences between PRINEO and subcuticular sutures or metal 
staples in wound complication rates over four postop follow-up points.  
HA: There are differences between PRINEO and subcuticular sutures or metal 
staples in wound complication rates. 
1.5 Aim 5: To evaluate the overall cost-effectives of PRINEO for wound closure relative 
to subcuticular sutures and metal staples 
H0: There are no differences between PRINEO, subcuticular sutures, and metal 
staples in cost-effectiveness over four postop follow-up points.  
HA: There are differences between PRINEO, subcuticular sutures, and metal 
staples in cost-effectiveness such that staples are superior to PRINEO and 
PRINEO is superior to subcuticular sutures.  
 
2.0 
Background  
 
 
 
 
 
 
 
 
 
 
 
• 
Interrupted sutures (0-0 vicryl) 
• 
Placed completely under the epidermal skin layer 
• 
Not removed post-operatively 
Figure 1. Dr. Richard Friedman treatment arm – control closure system. 
Deep layer – interrupted sutures 
Aneskey.com, adapted from Singer AJ, Hollander JE: Lacerations 
and acute wounds. Philadelphia, 2002, FA Davis. 
Adapted from Yasuda et al (2017)  
Superficial layer – metal staples   
• 
Removed Post-Operatively 10-14 days 
Pablo Paul / Alamy Stock Photo  

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A wound closure system requires proper closure of both deep and superficial tissue. 
Traditionally, knotted (interrupted) sutures are used for deep layer closures, in combination with 
either staples or subcuticular sutures for superficial skin closure. However, tissue adhesives such 
as Dermabond PRINEO act as an effective microbial barrier and effectively prevents wound 
dehiscence. With Dermabond PRINEO, running sutures can be used for both deep and 
Subcuticular suture. Wikimedia Commons. 
Dermabond, Sutureonline.com 
• 
Interrupted sutures (2-0 vicryl) 
• 
Placed completely under the epidermal skin layer 
• 
Not removed post-operatively 
Deep layer – interrupted sutures 
Aneskey.com, adapted from Singer AJ, Hollander JE: Lacerations 
and acute wounds. Philadelphia, 2002, FA Davis. 
Adapted from Yasuda et al (2017)  
Figure 2. Dr. Josef Eichinger treatment arm – control closure system. 
         Superficial layer - subcuticular sutures 
 
• 
Running, subcuticular sutures (32-0 Stratafix)  
• 
Traditional Dermabond applied to incision 
Figure 3. Dermabond PRINEO closure system.  
Deep layer – running sutures  
• 
Running, unidirectional sutures (2-0 Stratafix) 
• 
Placed completely under the epidermal skin layer 
• 
Not removed post-operatively 
Adapted from Stratafix Best Practices Video, Youtube 
Adapted from Yasuda et al (2017)  
 
Subcuticular suture. Wikimedia Commons 
Dermabond PRINEO, ethicon.com 
 
Superficial layer –  
subcuticular sutures + Dermabond PRINEO  
 
• 
Running, bidirectional sutures (3-0 Stratafix) 
• 
Dermabond PRINEO (60cm) or (22cm) 

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superficial closing, saving significant time. In this proposal, we define the PRINEO skin closure 
system as one that uses running unidirectional sutures for deep layer sutures and running 
bidirectional suture for superficial skin closure, followed by the Dermabond PRINEO with 
Medipore and 4x4 cotton gauze as additional wound dressing.  
 
Tissue adhesives like PRINEO are well-researched as alternatives for wound closure [1-5]. The 
common tissue adhesive, 2-octyl cyanoacrylate (OCA), has been used in surgical procedures 
since the 1950s and was FDA approved for use in wound closure in 1998 [6]. The OCA adhesive 
has been shown to reduce operating time, produce similar or improved cosmetic outcomes, 
similar or improved dehiscence and infection rates, and concurrent reduction in costs relative to 
the standard subcuticular suture method of closure [7-10]. The adhesive is also more flexible, 
allowing for easier application to incisions which span the joint [11].  
 
Although the PRINEO system is not uncommonly used for wound closure after joint 
replacement, there is limited research to document the relative outcomes of a PRINEO closing 
system in contrast to other methods. This prospective study will randomize shoulder arthroplasty 
patients to wound closure with the PRINEO adhesive-mesh system, metal staples, or by 
subcuticular system to determine the relative efficacy, safety, and cosmetic outcomes of the 
Dermabond PRINEO system for the shoulder. As the delto-pectoral incision for shoulder 
arthroplasty can be a visible scar and the shoulder joint is highly mobile, the successful 
implementation of the PRINEO system may have substantial effects on patient satisfaction with 
their wound healing and surgical scar.  
 
The efficiency and outcome of wound closure has also significance to operating room and clinic 
staff alike. Improving efficiency of wound closure, which may be particularly time consuming 
for long incisions in major surgery such as joint replacement, has cumulative effects in 
improving operating room flow and schedule adherence, and potentially, allowing for additional 
caseload. Removing sutures post-operatively may also be a time consuming process for clinic 
staff, in addition to being a source of discomfort for patients [1]. For this reason, interventions to 
optimize wound closure and ease of care are a highly relevant area of research. 
  

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 Figure 4: Outline of study design 
3.0  Intervention to be studied 
 
Specifically, in the 510(k) cleared Dermabond PRINEO skin closure system (Ethicon Inc.), 
the 2-octyl cyanoacrylate adhesive is used in combination with a polyester mesh tape, either 
22cm or 60cm in width. This mesh tape is designed to provide for tighter sealing of the 
incision and may further protect against discharge in more mobile wounds. Use of the tape 
may strengthen the wound closure and also simplify and improve alignment and apposition 
of wound edges [[12] and Ethicon internal testing]. Several prospective randomized, 
controlled trials have demonstrated consistently lower wound closing times and equivalent or 
significantly improved cosmetic outcomes and complication rates with this system [13-16]. 
More flexibility in application due to “body-contouring” has also been noted [17]. 
Observational studies of the PRINEO system report success use of the device as evaluated by 
surgeon and patient satisfaction [11, 17, 18]. Research of the PRINEO system used after total 
joint replacement are at present limited to retrospective studies [11, 18] and case reports of 
allergic reactions [19, 20].  
Dr. Richard Friedman currently closes incisions after shoulder arthroplasty with metal 
staples, and Dr. Josef Eichinger currently closes incisions after shoulder arthroplasty using 
subcuticular sutures with Dermabond. Both surgeons use interrupted deep-layer sutures. This 
study will consist of two parallel comparisons to these distinct control arms. The PRINEO 
closing method, which utilizes running deep and superficial sutures with Dermabond 
PRINEO, will be directly compared to each surgeon’s wound closure technique, as half of 
each surgeon’s patients will be randomized to the PRINEO treatment condition while the 
other half continue to undergo wound closure with the current technique utilized by the 

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surgeon. This will result in two parallel treatment arms and two distinct control arms (Fig. 1). 
Both surgeons have significant experience in the application of Dermabond PRINEO for 
wound closure.  
 
4.0 
Study Endpoints 
 
The duration of wound closure is primary endpoint for this study. Wound closure timing 
outcomes will be collected in the operating room towards the conclusion of each surgery. 
Closure time is the time between the first stitch for closure and the completion of 
application of dressing to the wound. The incision length will be measured to calculate 
time per centimeter.   
 
Cost per minute of operation time is another endpoint for the study. It will be 
conservatively approximated using existing reports of personnel capacity rates for 
orthopaedic surgeon. Cost-effectiveness analysis will be conducted by comparing the 
total cost of all wound closure materials for each technique, and a cost per minute applied 
to wound closure time.  
 
Wound outcomes, both clinical and cosmetic, will be another primary endpoint for this 
study. Patient-centered outcomes for wound and scar evaluation will be collected at 6 
weeks and 3 month postoperative appointments in clinic. These outcomes will be 
measured using the Modified Hollander Cosmesis Scale [14, 21], the Patient and 
Observer Scar Assessment Scale (POSAS) [14, 22, 23], and the Acute Inflammatory 
Response Evaluation (AIRE) score as described in the 2015 study by Blondeel et al [14].  
 
5.0 
Inclusion and Exclusion Criteria/ Study Population 
 
All adult (18 and older) patients undergoing primary total shoulder arthroplasty by Dr. 
Josef Eichinger or Dr. Richard Friedman will be considered for the study. Patients will be 
included if they are willing and have the capacity to provide informed consent, and if 
they expect to continue their post-operative follow up care with their operating surgeons 
at 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 ispilateral shoulder surgery utilizing the delto-pectoral approach; 

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• 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. 
 
6.0 
Number of Subjects 
 
A total of 88 patients, with 22 in each treatment group, will be enrolled. With a treatment 
and control arm for each surgeon, this results in a total of 44 patients in a treatment arm 
and 44 in a control.  
 
7.0 
Setting 
 
All research will be conducted at sites within the Medical University of South Carolina 
(MUSC) in Charleston, SC 
 
8.0 
Recruitment  
 
Only patients of the treating physicians (Dr. Eichinger and Dr. Friedman) who are 
indicated for total shoulder arthroplasty and meet all inclusion and exclusion criteria will 
be recruited. The treating physicians (either Dr. Eichinger or Dr. Friedman) will 
determine eligibility based on the indication for surgery and the patient’s medical history. 
Recruitment restricted to the surgeons’ patient base only.  
 
 
9.0       Consent Process: 
After patient’s eligibility is confirmed, patients will be approached by either the treating 
physician or other study staff to obtain informed consent. The consent process will take 
place in their private clinic room.  
 
There will be no dedicated waiting period between informing the subject of the study and 
obtaining consent. Patients who express interest in participating will then review the 
consent document with a member of the research team, who will explain the study and 
answer any questions that the patient has. They will be told that by signing they 
understand and are agreeing to the nature of the study but that consent is voluntary and 
can be withdrawn at any time. To ensure proper understanding, patients will be asked to 
summarize main components of the study, e.g. types of data collected and post-operative 
clinic visits. HIPAA authorization will be obtained with informed consent. 
 
Once the patient signs consent he/she will be given a copy of the signed form for his/her 
records. 

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10.0 
Study Design/ Methods 
 
Randomization will take place the morning of surgery based on a randomly organized, 
computer-generated order.  
 
Patients in Dr. RJ Friedman’s clinic will be randomized to one of two treatment 
conditions for wound closure after shoulder arthroplasty: 1) deep layer closure with 0-0 
vicryl interrupted sutures followed by superficial skin closure with metal staples with 
aquacel dressing and 2) deep layer closure with a running 2-0 unidirectional Stratafix 
suture followed by superficial closure with subcuticular bidirectional 3-0 Stratafix suture 
followed by the Dermabond PRINEO (60cm or 22cm polyester mesh and 2-octyl 
cyanoacrylate adhesive) with Medipore and folded 4x4 cotton gauze dressing.  
Patients in Dr. JK Eichinger’s clinic will be randomized to one of two treatment 
conditions for wound closure after shoulder arthroplasty: 1) deep closure with interrupted 
2-0 vicryl sutures followed by a running subcuticular bidirectional 3-0 Stratafix with 
Dermabond and Medipore dressing with folded 4x4 cotton gauze dressing and 2) deep 
layer closure with a running 2-0 unidirectional Stratafix suture followed by superficial 
closure with subcuticular bidirectional 3-0 Stratafix suture followed by the Dermabond 
PRINEO (60cm or 22cm polyester mesh and 2-octyl cyanoacrylate adhesive) with 
Medipore and folded 4x4 cotton gauze dressing.  
 
The rationale for investigating the current practice of deep closure with interrupted 
sutures is as follows: Using running suture introduces a potential risk of wound 
dehiscence if the suture fails at any juncture despite the presence of the barbs. The 
Dermabond PRINEO represents a powerful closure mechanism that in all probability 
eliminates the risk of wound dehiscence regardless of the skin closure method. Therefore, 
using a rapid wound closure method with deep layer running sutures is now a possibility 
with the Dermabond PRINEO that was not available before.   
 
Patients will not be made aware of the treatment they are randomized to until their first 
follow up visit or when wound dressing is removed to reveal the device used for wound 
closure.  
 
At the conclusion of the surgery, the assigned wound closure technique will be 
implemented. The following data points to measure the primary outcome, wound closure 
efficiency, will be collected in the operating room:  
1. Total operating time in minutes and seconds, from the first incision to the application 
of wound dressing.  
2. Total time for wound closure in minutes and seconds, from the first stitch for closure 
to the application of wound dressing.  
3. The incision length in centimeters 

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4. The cost of materials utilized for wound closure (suture, Dermabond, PRINEO, 
staples, dressings, etc.) 
 All patients will be seen in clinic 2 weeks post operatively during which time the wound 
closure technique (sutures, or staples) will be removed by a nurse according to the 
manufacturer and standard technique. The patients who are randomized to o Dermabond 
PRINEO will be instructed to keep their polymer mesh on for an additional 2 weeks after 
their 2 weeks visit. Any complications such as drainage, acute inflammation, or signs of 
infection will be recorded at this time and treated per clinical standards. The following 
data points to measure wound clinical and cosmetic outcomes, will be collected at 6 
weeks and 3 months postoperatively: 
1. mHCS score 
2. AIRE score 
3. POSAS score 
4. Complications and adverse events 
 mHCS, AIRE, and POSAS scores are all dependent on aspects of the physical exam, 
such as evaluation of pliability, temperature, edema, pain, and contour. To mitigate any 
observer bias, all incisions will be photographed and additionally evaluated by a plastic 
surgeon (MLT) blinded to the treatment condition using the POSAS-Observer 
characteristics which may assessed through standardized photography alone (Vascularity, 
Pigmentation, Thickness, Relief, Surface Area, and Overall Opinion).  
 
A medical record review will also be performed to collect the following data: 
Age; gender; BMI (including height and weight), race, diabetes status (type, insulin 
dependency, years diagnosed); history of smoking/tobacco use; frequency of alcohol 
consumption.  
 
11.0 
Data Management 
 
Justification of sample size:  
The Cohen’s effect size of 0.93 corresponds to a difference of means of 7.5 minutes with 
a pooled standard deviation of 8 minutes. The PI has determined that a difference of 10 
minutes will be the minimum significant difference for clinical and economic relevance. 
5 minutes alternatively would be an irrelevant amount of time savings.  Therefore, 
designing the investigation to detect 7.5 minutes would ensure that we would determine if 
10 minutes difference exists between the different wound closure techniques. 
Economically, at an estimated cost of $30 per minute of operative time [24], this 
corresponds to $300 saved per procedure. Ten fewer minutes of operative time across six 
consecutive shoulder arthroplasties would save an hour total of operative time, which 
allows for the possible inclusion of a seventh surgery in the operative room schedule.  
 
In our study, differences in time to closure between the groups will be compared by two-
sample T-tests for independent means. With a Cohen’s effect size of 0.93, a standard 

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alpha of 0.05 to determine statistical significance, and a target power of 0.80, an apriori 
power analysis indicates 76 total for the sample size, or 19 per group. A sample size of 88 
total patients, with 22 in each group (two parallel treatment arms and two distinct control 
arms each representing surgeon’s choice), will ensure sufficient power to detect 
economically relevant, statistically significant differences in time to closure outcomes 
between the three wound closure methods, while leaving room to accommodate patients 
who withdraw from the study or are lost to follow up.   
 
Data storage and management: 
As multiple data points will be collected for each patient over the course of their 
treatment, an enrollment log will be established, assigning patients unique identifiers, and 
a data sheet will be started where the total operating time, the wound closure time, the 
cost of wound closure, and the incision length will be recorded. Furthermore, the mHCS 
score, the AIRE score, the POSAS scores, and complications will be recorded in this data 
sheet for each postoperative visit to the clinic (at 6 weeks and 3 months).  
Upon enrollment, patients will be assigned unique identifiers to be used in statistical 
analysis. Enrollment logs, data sheets and photographs will be electronically stored 
within a MUSC password protected secured computer, in a MUSC supported password-
protected digital folder, accessible only to the members of the research team. Copies of 
consent forms, visit report forms, and adverse event forms will be stored in a locked 
cabinet in a locked room on the Medical University of South Carolina campus in 
downtown Charleston, SC. If a patient has a unique, identifying tattoo near his/her 
incision site, the tattoo will be avoided during photographing or blurred out digitally 
before storage. If the tattoo is within 2 inches of the site and therefore difficult to avoid or 
blur without compromising the image quality of the wound, the patient will be excluded 
from the study. 
 
Data analysis plan: 
Data from patients’ medical records to be included in the data sheet to include as 
covariates during data analysis will include age, gender, BMI, race, diabetes status, 
history of smoking/tobacco use, and alcohol consumption. The differences in mHCS, 
AIRE, and POSAS scores between treatment groups will be tested through ANOVA tests 
and subsequent Tukey-HSD post-hoc tests, and difference in complication rates will be 
evaluated by Chi-square tests. Analysis will be conducted on MUSC registered 
computers through IBM SPSS 25.0.  
 
 
12.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects (if applicable) 
 
Adverse events will be collected at follow up visits and PI will review them regularly and 
report them per MUSC IRBs policy. 
 
 

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13.0 
Withdrawal of Subjects (if applicable) 
Subjects may opt to withdraw from the study at any time point between enrollment and 
the conclusion of data analysis. Patients can withdraw from the study by communicating 
their desire to do so through email, over the phone or in person with any study team 
member.  
 
14.0 
Risks to Subjects 
 
There are no additional risks to subjects in the subcuticular sutures and metal staples 
(control) treatment arms. For these control groups, the only potential risks to subjects 
arise from the standard of care for shoulder arthroplasty wound treatments.  
 
However, there is risk associated with randomization to the treatment group. PRINEO is 
a well-established and widely available method of wound closure. While several case 
reports of allergic contact dermatitis reactions after use of PRINEO for wound closure 
have been published, the overall rate of allergic reaction remains fairly low (between 0% 
to 1.8% in the literature) [19, 20, 25, 26]. Cases of contact dermatitis around the incision 
have been successfully managed with topical and oral steroids and have not resulted in a 
higher risk for superficial or deep wound infection [20]. Nonetheless, all patients will be 
informed of the risk of allergic reaction, will be excluded based on prior history of 
hypersensitivity to cyanoacrylate, formaldehyde, benzalkonium chloride, or pressure 
sensitive adhesive, and will be monitored closely at their 2 week follow up appointment 
to promptly manage any signs of irritation, blistering, or inflammation. Any adverse 
event experienced by patients in the experimental arm will be addressed per the standard 
clinical treatments. 
 
There is also a risk of loss of confidentiality which will be mitigated by coding the 
research data set and storing study data securely. Finally, there might be unknown risks 
of using PRINEO on the shoulder that will be monitored throughout the study. 
 
 
15.0 
Potential Benefits to Subjects or Others 
 
Patients assigned to the control treatment arms will not receive any additional benefits 
from participating in the study. Patients randomized to the PRINEO treatment arm may 
benefit from less time in the operating room and greater ease of care postoperatively, 
such as reduced pain and no need to remove suture or staples at the first postoperative 
appointment. Prior randomized, controlled clinical studies of the PRINEO closure system 
have demonstrated that use of the system is associated with shorter operating times, 
equivalent or lower complication rates, and equivalent or improved cosmetic outcomes 
[13-16].  

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16.0 
Drugs or Devices (if applicable) 
 
The PRINEO system, subcuticular sutures, and metal staples are all readily available at 
MUSC operating room settings and are commonly used by various surgeons in these 
settings.  
 
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