Preoperative Application of Low-level Microcurrent Dressing (Jumpstart) for Decolonization of P. Acnes Before Shoulder Surgery
Phase: NA
Conditions: Shoulder Arthropathy Associated With Other Conditions
Sponsor: Milton S. Hershey Medical Center

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HRP-592 - Protocol for Human Subject 
Research with Use of Test Article(s)
Protocol Title:
Preoperative application of low-level microcurrent dressing (Jumpstart) for decolonization of P. acnes before shoulder 
surgery
Principal Investigator:
Name: H. Mike Kim
Department: Department of Orthopedic Surgery
Telephone: 717-531-4826
E-mail Address: hkim2@pennstatehealth.psu.edu
Version Date:
2/19/2019
Clinicaltrials.gov Registration #:  NCT03466658
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Table of Contents
1.0
Objectives
2.0
Background
3.0
Inclusion and Exclusion Criteria
4.0
Recruitment Methods
5.0
Consent Process and Documentation
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
7.0
Study Design and Procedures
8.0
Subject Numbers and Statistical Plan
9.0
Confidentiality, Privacy and Data Management
10.0
Data and Safety Monitoring Plan
11.0
Risks
12.0
Potential Benefits to Subjects and Others
13.0
Sharing Results with Subjects
14.0
Subject Stipend (Compensation) and/or Travel Reimbursements
15.0
Economic Burden to Subjects
16.0
Resources Available
17.0
Other Approvals
18.0
Multi-Site Research
19.0
Adverse Event Reporting
20.0
Study Monitoring, Auditing and Inspecting
21.0
Future Undetermined Research: Data and Specimen Banking
22.0
References
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1.0
Objectives
1.1
Study Objectives
To evaluate the efficacy of preoperative treatment with a novel, wireless, low-level microcurrent-generating 
antimicrobial device (brand name: JumpStart) in preventing the spread of Propionibacterium acnes in patients receiving 
open or arthroscopic shoulder surgery.  Vomaris distributes Procellera ™ AMT (advanced microcurrent technology) 
under the name Jumpstart™, exclusively through Arthrex, Inc.  The FDA 510 documentation for Vomaris Procellera is 
attached in a separate document (as well as documentation regarding the distribution through Arthrex).
1.2
Primary Study Endpoints
The primary outcome measures the intraoperative culture results (e.g. positive vs negative, days to 
positive conversion) for P. acnes by evaluating bacterial cultures from punch skin biopsies at the time of 
the surgery. Any change in the condition of the biopsied area will be recorded and followed, including 
infections, as part of the routine care visits.
1.3
Secondary Study Endpoints
No secondary endpoints
2.0
Background
2.1
Scientific Background and Gaps
The spread of multi-drug resistant bacteria and financial burden of periprosthetic joint infection 
exacerbate the need for treatments to address pathogenic contamination and expedite healing. 
Although rare, these infections can place a great financial burden on the health care system and are 
often associated with increased hospital length of stay, compromised function, reduced quality of living, 
and increased likelihood of follow-up surgeries. Bacterial infection can further compound this problem 
with the widespread, prolonged use of prolonged antimicrobial prophylaxis. It is know that there is a 
high frequency of infections after open and arthroscopic shoulder surgery caused by Propionibacterium 
acnes. Because P. acnes normally colonizes under the epidermal layer in sebaceous glands, topical skin 
preparations, skin cleansers, and antibiotics may be unable to completely penetrate the deep layers of 
the skin to eradicate its colonization in all layers of the skin. 
Lee et al. (2014) showed how P. acnes, which normally resides in the skin, can continue to persist in the 
skin despite standard surgical preparation. Ten healthy male subjects had received skin preparation of 
their upper back with ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol) and two 3-
mm dermal punch biopsy specimens were subsequently obtained. These dermal cultures were positive 
for P. acnes in 7 out of 10 subjects, where 4 subjects had P. acnes grow from 1 of 2 biopsies taken, 
whereas 3 subjects had it grown on 2 of 2 biopsies taken. This study showed how P. acnes persists in 
dermal tissue even with surface skin preparation that is considered standard in orthopedic surgery, at 
much higher rate than previously reported. 
Namdari et al. (2017) studied the efficacy and safety of preoperative oral administration of doxycycline 
in decolonizing P. acnes from the skin over the shoulder in a randomized controlled trial. Patients, who 
were prospectively undergoing shoulder arthroscopy, were randomized in either the drug group (n=37) 
or standard of care (no drug) group (n=37), where the drug group administered oral doxycycline for 7 
days before the surgery. Before the surgery, 2 separate 3-mm punch biopsy specimens were obtained 
from the sites of the anterior and posterior arthroscopic portals and were sent for culture in anaerobic 
and aerobic medium held for 13 days. Results showed that 22 patients in the no-drug group had at least 
1 positive dermal culture, where 10 patients had 1 positive culture and 12 had 2 positive cultures. 16 
patients in the drug group had at least 1 positive dermal culture, where 6 patients had 1 positive culture 
and 10 had 2 positive cultures. This data showed that the administration of oral doxycycline for 7 days 
before the did not reduce the colonization of P. acnes in a significant manner. 
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A novel, wireless, low-level microcurrent-generating antimicrobial device has been observed, in vitro, to 
exhibit electricidal effect in the presence of antibiotic and multidrug resistant clinical wound isolates. 
These energy-based systems were originally employed to augment wound healing process, reduce 
infection, and address edema and pain in the recent decades. Low-level microcurrents have been 
recently expanded into the orthopedic space as a bacterial growth inhibitor both in vitro and in vivo. 
Procellera (JumpStart) is a sterile single layer dressing consisting of a matrix of alternating silver (Ag) and 
zinc (Zn) dots that are held in positions on a polyester substrate with biocompatible binder. Dressing is 
then activated in the presence of a conductive fluid, which may come from wound exudate or 
exogenous fluids, such as saline.
Many studies have been done already on the wound healing and pain management properties of 
JumpStart, but only few have explored its bactericidal properties. Below is the summary of current 
literature related to this topic. The first study didn’t look particularly at the antimicrobial effects, but 
rather the overall benefit of these microcurrent-generating dressings on patients who received knee 
replacements. The second study summarizes the in vitro antimicrobial properties of the dressings 
against various drug-resistant bacteria.
Chow (2016) performed a single-institution chart review to see the benefit of novel microcurrent-
generating antimicrobial dressing (MCD) on patients who received total knee arthroplasty. The study 
was conducted on 92 patients who were all treated with MCD as a postoperative treatment from 2010 
to 2013. MCD was applied using aseptic technique, directly on top of the adhesive skin closure strips, 
and was electrically activated and maintained moist by saturating with sterile hydrogel upon application. 
MCD was then covered with semi-occlusive dressing to secure it in place and to maintain a moist healing 
environment. Dressings were scheduled to be removed after a week post-procedure. 
The results show that the use of MCD as an adjunct to standard surgical closure methods is safe and 
effective. The mean length of stay at the hospital was ~2.3 days, the mean length of treatment with 
MCD was ~8.3 days, and the mean follow-up time was 341 (+/- 177 days). There was no infection 
observed, compared to 1.6% reported without MCD (found in literature), and the 30-day post-operative 
readmission rate was 2%, compared to 4% reported without MCD (found in literature). Knee Society 
Score function showed statistically significant improvements post-operatively, with a mean 6-month 
score of 75 (+/- 20.3) and mean improvement of 36.3 (+/- 21.1). 
Kim et al. (2014) studied the in vitro efficacy of the antibacterial properties of bioelectric dressings 
containing silver and zinc against clinical wound isolates having unknown antibiotic resistance, including 
beta-lactamase (ESBL) bacteria, multidrug-resistant (MDR) bacteria, and methicillin-resistant 
Staphylococcus aureus (MRSA). Except for the E. faecalis isolates, all types of clinical bacterial isolates 
were killed completely within 24 hours of exposure to the bioelectric wound dressing, indicating the 
dressing has broad-spectrum bactericidal activity. For potential bacteriostatic Enterococcus isolates 
were also tested to determine how such isolates would react to longer incubation times of up to 48 
hours. With the exception of E. raffinosus isolate, all the Enterococcus bacterial isolates had slightly 
decreased growth at 48 hours compared to with those exposed to the bioelectric wound dressing for 24 
hours. The authors hypothesize that the Ag-Zn resistance in Enterococcus species may depend on the 
activation of endogenous silver and/or zinc efflux systems. 
To date, no MRSA strains have been found to possess Ag-resistant genes, and there is no known 
mechanism of bacterial resistance to all heavy metal ions. However, studies have suggested that the 
widespread and uncontrolled use of Ag+ in wound care may result in more bacteria developing 
resistance. 
2.2
Previous Data
No preliminary data.
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2.3
Study Rationale
From current literature search, there is no study that evaluates the antimicrobial prophylaxis of 
microcurrent-generating antimicrobial dressings (e.g. JumpStart) for shoulder procedures in vivo. 
3.0
Inclusion and Exclusion Criteria
3.1
Inclusion Criteria
-
18 years old or older
-
Scheduled to receive open or arthroscopic shoulder surgery
3.2
Exclusion Criteria
-
17 years old or younger
-
Pregnant women
-
Prisoners
-
Non-English speaking or unable to understand consent 
-
-
History of previous shoulder infection or clinical signs of preoperative infection
-
History of taking any antibiotic(s) within 4 weeks prior to the scheduled shoulder surgery
-
History of allergy to zinc and silver
-
No lesions, active acne or skin inflammatory disorders (psoriasis, eczema, etc.) in either shoulder
3.3
Early Withdrawal of Subjects
3.3.1
Criteria for removal from study
Patients will be removed from the study if reasons for safety or if the patient wishes to 
withdraw from the study.
3.3.2
Follow-up for withdrawn subjects
Patients withdrawn for any reason will be followed up as the standard of care protocol. 
4.0
Recruitment Methods
4.1
Identification of subjects
Patients will be identified in the Orthopedics Clinic for indications of open or arthroscopic shoulder 
surgery. Patients will be asked to join the study if they meet the selection criteria and agree to the plan 
of care with the microcurrent-generating antimicrobial dressing.  
4.2
Recruitment process
Patients will be recruited in the clinic for the study. The shoulder and elbow surgeons will provide the 
purpose and information of the study to the patient. An investigator will consent patients to the study if 
they wish to join.
4.3
Recruitment materials
NA
4.4
Eligibility/screening of subjects
Patients will be identified in clinic during their standard of care visit. 
5.0
Consent Process and Documentation
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5.1
Consent Process 
 
5.1.1
Obtaining Informed Consent
5.1.1.1
Timing and Location of Consent
Written consent will be obtained in the clinic with each patient
5.1.1.2
Coercion or Undue Influence during Consent
An investigator will obtain consent for involvement in the study in the clinic.  
The investigator will express that this is an academic study and patient 
involvement is not necessary to their care.  The patient has full right to choose 
to be involved with the study or to decline and it will not affect their care.
5.1.2
Waiver or alteration of the informed consent requirement
Waiver of informed consent is requested to review patients’ medical records to identify 
potential subjects. There is no more than minimal risk to the privacy or welfare of included 
subjects in this retrospective research study. Data will be entered into study databases only. 
Only approved investigators may perform the retrospective data collection. No active research 
intervention is taking place. 
5.2
Consent Documentation
5.2.1
Written Documentation of Consent
Written consent form is attached to this IRB submission
5.2.2
Waiver of Documentation of Consent (Implied consent, Verbal consent, etc.)
N/A
5.3
Consent – Other Considerations 
5.3.1
Non-English Speaking Subjects
Patients who are non-English speakers will be excluded from this study.
5.3.2
Cognitively Impaired Adults
5.3.2.1 Capability of Providing Consent
Patients not able to provide consent will be excluded.  Whether the patient is able 
to provide informed consent will be decided by the PI.
5.3.2.2
Adults Unable To Consent
N/A
5.3.2.3 Assent of Adults Unable to Consent
N/A
5.3.3
Subjects who are not yet adults (infants, children, teenagers) 
5.3.3.1 Parental Permission
N/A
5.3.3.2 Assent of subjects who are not yet adults
N/A
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6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
6.1
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
Check all that apply:
 
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable]
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable]
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3]
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3]
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3]
6.2
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
6.2.1
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual
6.2.1.1 Plan to protect PHI from improper use or disclosure
 Information is included in the “Confidentiality, Privacy and Data Management” 
section of this protocol.
6.2.1.2 Plan to destroy identifiers or a justification for retaining identifiers 
Identifiers will be destroyed when the PI closes the study.
6.2.2
Explanation for why the research could not practicably be conducted without access to and 
use of PHI
The medical record will be reviewed during the clinic visit to determine eligibility.
6.2.3
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization
Waiver to view the medical record is necessary to determine eligibility.
6.3
Waiver or alteration of authorization statements of agreement
Protected health information obtained as part of this research will not be reused or disclosed to any 
other person or entity, except as required by law, for authorized oversight of the research study, or for 
other permitted uses and disclosures according to federal regulations. 
The research team will collect only information essential to the study and in accord with the ‘Minimum 
Necessary’ standard (information reasonably necessary to accomplish the objectives of the research) 
per federal regulations. 
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Access to the information will be limited, to the greatest extent possible, within the research team. All 
disclosures or releases of identifiable information granted under this waiver will be accounted for and 
documented.
7.0
Study Design and Procedures
7.1
Study Design
Thirty patients will be identified in the clinic with indications for open or arthroscopic shoulder surgery. 
Patients will be informed about the current prospective study and written consent will be obtained. 
Both shoulders of each patient will be included for the study; the surgical side shoulder will serve as a 
“Treatment shoulder” while the normal non-operative contralateral shoulder will serve as a “Control 
shoulder”. All patients will receive a wireless, low-level microcurrent-generating antimicrobial dressing 
(JumpStart® Antimicrobial Wound Dressing, Arthrex, Inc., Naples, Florida, USA) (Figure 1) and hydrogel 
on the posterior aspect of their Treatment shoulder 2 days prior to their surgery. A small amount of 
hydrogel will be applied to the undersurface of JumpStart dressing. The adhesive dressing will make the 
JumpStart stick to the skin.  The dressing will be kept on the shoulder until the time the patient is 
transferred to the operating room on the day of surgery. The dressing will be applied by a member of 
the research team at clinic. Upon transfer to the operating room on the day of surgery, the JumpStart 
dressing will be removed from the Treatment shoulder. All patients will receive routine preoperative IV 
antibiotics (either Cefazolin or Clindamycin) at least 5 minutes prior to skin incision and a routine 
operative skin preparation for both shoulders using standard, alcohol-based preparation (ChloraPrep, 
2% chlorhexidine gluconate and 70% isopropyl alcohol; Enturia, El Paso, TX, USA) immediately before 
skin incision in the operating room. 
At the time of the surgery, 2 separate 3-mm punch biopsy specimens will be taken from the posterior 
shoulder skin of both shoulders using a disposable biopsy punch (Disposable Biopsy Punch; Robbins 
Instruments, Chatham, NJ, USA) (Figure 2) . The biopsy sites will be closed with an adhesive tape (Steri-
Strip, 3M, Maplewood, MN, USA) and covered with a routine gauze dressing.  Samples will be 
transferred directly into separate sterile specimen containers from the biopsy punches using clean, 
sterile forceps. Specimens will then be transferred directly to a single laboratory for culture. Anaerobic 
and aerobic culture substrates will be used and held for 14 days for P. acnes only, given literature that 
shows P. acnes can grow on either substrate. Anaerobic culture plates will be incubated for 4 days and 
broth cultures for 14 days before concluding that the final report is negative. To serve as a “negative 
control,” while wearing sterile gloves, in the first 20 patients, a sterile culture swab will be opened in the 
operating room, wiped through the air, and sealed in a specimen container. Chocolate plate will serve as 
a settle plate in the OR suite for 10 minutes and incubated for 4 days. Data will include demographic 
data of patients, positive culture rates, and the number of days before resulting in positive culture. All 
culture results will be reviewed and the patient will be marked positive if any of the cultures were 
positive. Patients will be scheduled for postoperative, routine follow-up visits. The rest of patient care 
will follow our current routine standard care without any modifications or interventions.  
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7.2
Study Procedures
7.2.1
Pre-operation 
Patient will be seen in the outpatient clinic during their standard of care 1 week pre-operation 
visit. Patient will be provided information about the study, consented, and recruited to the 
study. Following the consent, patients will have a research visit scheduled 2 days before surgery 
to have the JumpStart dressing material applied to their operative shoulder by a member of the 
research team.  The JumpStart dressing will be kept until the day of surgery. Excessive hair will 
be removed from the dressing site at the time of dressing application to ensure a secure 
dressing attachment. All patients will receive standard of care pre-operation routine skin care 
instructions during the visit as all patients receive having this type of surgery. 
7.2.2
Post-operation
Patients will follow our current routine standard care follow-up protocol for each surgical 
procedure. The biopsy sites will be carefully examined by the PI or his patient care team to 
ensure proper healing upon each postoperative return visit. The first postoperative visit is at 2 
weeks after surgery. Any wound problems such as bleeding, drainage, abnormally increased 
pain, feeling of local warmth, erythema, and abnormal swelling will be immediately reported to 
the PI or his patient care team.  The duration of the post-operation routine care follow-up can 
take place between a few weeks to several months depending on the procedure. The culture 
results will be obtained within 14 days post-operation. Any change in the condition of the 
biopsied area will be recorded and followed, including infections, as part of the routine care 
visits.
7.3
Duration of Participation
Patients will be involved in this study only during the time of their shoulder surgery, which include pre-
operation consent and post-operation routine follow-up. Pre-operation consent will mark the beginning 
of the patients’ participation and will take place approximately 1 week before the surgery. The patients 
will use the dressing only during this pre-operation period. The pre-operative visit will take 
approximately 30 minutes. Application of the dressing in clinic will take approximately 30 minutes. The 
skin biopsies in the operating room will take about 5 minutes to obtain. The duration of the post-
operation routine care follow-up can take place between a few weeks to several months depending on 
the procedure. The culture results will be obtained within 14 days post-operation. Any change in the 
condition of the biopsied area will be recorded and followed, including infections, as part of the routine 
care visits.
Figure 2
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7.4
Test Article(s) (Study Drug(s) and/or Study Device(s))
7.4.1
Description
In each patient, the Treatment shoulder will receive preoperative applications of a wireless, low-
level microcurrent-generating antimicrobial device (JumpStart® Antimicrobial Wound Dressing, 
Arthrex, Inc., Naples, Florida, USA) 2 days prior to their surgery. The control will not receive this 
treatment. On the day of surgery, in the operating room, both shoulders will receive 
preoperative applications of standard, alcohol-based preparation (ChloraPrep, 2% chlorhexidine 
gluconate and 70% isopropyl alcohol; Enturia, El Paso, TX, USA) immediately before the surgery. 
JumpStart is a broad-spectrum antimicrobial wound dressing featuring Advanced Microcurrent 
Technology™. Embedded in the dressing are microcell batteries made of elemental silver and 
zinc applied in a dot-matrix pattern to a polyester substrate. In the presence of a conductive 
medium such as wound exudate, water-based hydrogels or saline, microcurrents are generated 
at the dressing surface, due to its inherent design.
7.4.2
Treatment Regimen
The dressings will be applied over the posterior aspect of the shoulder above the posterior 
axilla. 
7.4.3
Method for Assigning Subject to Treatment Groups
NA
7.4.4
Subject Compliance Monitoring
7.4.5
Blinding of the Test Article
N/A 
7.4.6
Receiving, Storage, Dispensing and Return 
7.4.6.1
Receipt of Test Article 
All of the standard-of-care alcohol-based prep, iodine-barrier drapes are already 
available both at the main operating rooms and HOSC operating rooms. The 
alcohol-based prep and iodine-barrier drapes have been routinely used for 
shoulder cases in the main operating rooms and HOSC operating rooms.  The 
JumpStart dressing has been used in standard of care, select cases for 
immediate postoperative dressing and is available in the main operating room.
For this study, we will purchase JumpStart dressings from the vender (Arthrex, 
Naples, FL) using the PI’s personal research fund. Each package will contain 8” x 
8” Antimicrobial Wound Dressing that can be cut to fit surgical sites and shape 
conforms easily to body contours for patient comfort. 
7.4.6.2
Storage
The dressing will be stored in dry conditions at controlled room temperature, 
protected from light. Controlled room temperature is 20oC to 25oC (68oF to 
77oF). Excursions are permitted between 15oC and 30oC (59oF and 86oF). Brief 
exposure to temperatures up to 40oC (104oF) may be tolerated provided the 
mean kinetic temperature does not exceed 25oC (77oF); however, such exposure 
will be minimized. 
Dressing will be stored in a locked office 30 Hope Drive, Suite 2900 in a locked 
metal cabinet, separated from other clinical supplies, in the Clinical Research 
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Office. The room is temperature controlled, and its temperature will be 
monitored via the thermostat and recorded on a temperature log daily. 
7.4.6.3
Preparation and Dispensing
The application of the dressings will be prepared and administered by an 
investigator on the study team in clinic from the research supply. The dressing 
will be disposed according to local environmental procedures.
7.4.6.4
Return or Destruction of the Test Article
N/A
7.4.6.5
Prior and Concomitant Therapy
The dressing cannot be applied in conjunction with topical agents such as 
antimicrobial ointments, enzymatic debriders, antibiotic creams or ointments, 
silver- or zinc-containing creams, oxidizing agents, or petroleum-based 
products. The dressing must be removed during energy-based procedures (e.g. 
radiofrequencies, ultrasound, or radiation) where the dressing may interfere 
with delivery. 
8.0
Subject Numbers and Statistical Plan
8.1
Number of Subjects
Thirty patients will be recruited for this study.
8.2
Sample size determination
A priori sample size calculation was performed using some of the previously published data1,2. 
Assumptions were made as follows: the primary outcome measure was the intraoperative culture 
results (e.g. positive, negative) for P. acnes by evaluating bacterial cultures from two skin biopsies 
obtained from the posterior aspect of the shoulder at the time of the surgery. Based on a previous 
study, the positive culture rate in untreated shoulders was set at 60%5. We set the minimally clinically 
significant difference (MCID) of positive culture rate at 30% (a half of 60%) as a previous study 
described2. Using a two-tailed McNemar test for two dependent groups with a power of 0.8 and an 
alpha of 0.05, the priori sample size calculation suggested a total of 30 patients for the study.  
Treatment shoulder
Probability
Positive culture
Negative culture
Positive culture
0.25
0.35
0.6
Control shoulder
Negative culture
0.05
0.35
0.4
0.3
0.7
1
Exact - Proportions: Inequality, two dependent groups (McNemar) 
Options:
α balancing: α/2 on each side, approximation
Analysis:
A priori: Compute required sample size 
Input:
Tail(s)                   
=
Two
Odds ratio                
=
7
α err prob                
=
0.05
Power (1-β err prob)      =
0.8
Prop discordant pairs     =
0.4
Output:
Lower critical N          
=
2.0000000
Upper critical N          
=
10.0000000
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Total sample size         
=
30
Actual power              
=
0.8180007
Actual α                  
=
0.0385742
Proportion p12            
=
0.3500000
Proportion p21            
=
0.0500000
8.3
Statistical methods
If at least one of the two cultures from a shoulder turns positive, that shoulder will be counted as a 
“positive culture” shoulder. The results of the two cultures from each shoulder will be McNemar test will 
be used to compare the proportions of positive culture rates between paired shoulders. Ordinal or 
interval Demographic data will be compared between the two groups using parametric vs 
nonparametric tests depending on their normality. Nominal data will be compared using Fisher’s exact 
test or contingency table. The negative control data will be analyzed in comparison to the results of the 
treatment and normal control shoulders. 
9.0
Confidentiality, Privacy and Data Management 
See the Research Data Plan Review Form.
10.0 Data and Safety Monitoring Plan
10.1
Periodic evaluation of data
Data will be reviewed periodically by the PI for the accuracy during the data collection period.
10.2
Data that are reviewed
Previously stated data will be secured with password protection. Staff members will periodically review 
safety and security protocols for project. 
10.3
Method of collection of safety information
The duration of the post-operation routine care follow-up can take place between a few weeks to 
several months depending on the procedure. The culture results will be obtained within 14 days post-
operation. Any change in the condition of the biopsied area will be recorded and followed, including 
infections, as part of the routine care visits.
10.4
Frequency of data collection
The skin biopsies will be obtained only at the time of surgery. The biopsies will be sent to the 
microbiology lab for cultures. The culture results will be obtained within 14 days post-operation. No 
further follow up data collection will be performed directly from patients after their surgery.
10.5
Individuals reviewing the data
Research members will review data.
10.6
Frequency of review of cumulative data
Cumulative data will be reviewed once patient surveys are collected and patient information is de-
identified.
10.7
Statistical tests
The proportion of positive cultures will be determined using Fisher’s exact test to compare the positive 
culture rates. Ordinal or interval Demographic data will be compared between the two groups using 
parametric vs nonparametric tests depending on their normality. Nominal data will be compared using 
Fisher’s exact test or contingency table. 
10.8
Suspension of research
Research will be suspended if project is determined unsafe at any time for patients.
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11.0 Risks
Loss of patient information during the project. Loss of confidentiality of paper and electronic data. Possible risks 
of skin biopsies include acute bleeding, localized pain, infection, scarring, and healing problems. Possible risks of 
dressing use include irritation, increased pain, temporary discoloration of the skin, and allergic reactions to silver 
or zinc. 
12.0 Potential Benefits to Subjects and Others
12.1
Potential Benefits to Subjects
Microcurrent-generating antimicrobial device has been observed, in vitro, to exhibit bactericidal effect 
in the presence of antibiotic and multidrug resistant clinical wound isolates. Antimicrobial prophylaxis 
using this device can reduce length of hospital stay, compromised function, and financial burden while 
increasing quality of living. 
12.2
Potential Benefits to Others
Preventing periprosthetic joint infection post-operation can reduce financial burden on the health care 
system and prevent unnecessary, prolonged use of antibiotics as antimicrobial prophylaxis.
13.0 Sharing Results with Subjects
The patients will be notified if infections are suspected and will be followed up with appropriate revision surgery 
or any required additional procedures for infections. 
14.0 Subject Stipend (Compensation) and/or Travel Reimbursements
No compensation will be provided for this study.
15.0 Economic Burden to Subjects
15.1
Costs 
No cost to the patients.
15.2
Compensation for research-related injury
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Costs for the treatment of research-related injuries 
will be charged to subjects or their insurance carriers.
16.0 Resources Available
16.1
Facilities and locations
Recruitment will occur at Penn State Bone and Joint Institute or Penn State Camp Hill office. Eligible 
patients will be identified at clinic during their clinical encounter with Dr. Kim. All surgeries will be done 
at Hershey Medical Center and HOSC. 
16.2
Feasibility of recruiting the required number of subjects
This project aims to recruit 30 patients for this study. Patients will be followed up by the Department of 
Orthopedics. Patients who decline participation in the study will be removed and a new patient will be 
recruited. 
16.3
PI Time devoted to conducting the research
PI has dedicated research days to ensure time to complete project.
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16.4
Availability of medical or psychological resources
Orthopedics clinic will schedule patients if they require an appointment during this study.
16.5
Process for informing Study Team
Team members have monthly meetings in person to review protocols.
17.0 Other Approvals
17.1
Other Approvals from External Entities
No additional approvals required.
17.2
Internal PSU Committee Approvals
Check all that apply:
  Anatomic Pathology – Hershey only – Research involves the collection of tissues or use of pathologic 
specimens. Upload a copy of HRP-902 - Human Tissue For Research Form on the “Supporting 
Documents” page in CATS IRB. This form is available in the CATS IRB Library.
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA or 
gene therapy). 
  Clinical Laboratories – Hershey only – Collection, processing and/or storage of extra tubes of body 
fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids that had 
been collected for clinical purposes, but are no longer needed for clinical use. Upload a copy of HRP-901 
- Human Body Fluids for Research Form on the “Supporting Documents” page in CATS IRB. This form is 
available in the CATS IRB Library.
  Clinical Research Center (CRC) Advisory Committee– All campuses – Research involves the use of 
CRC services in any way.  
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest.
  Radiation Safety – Hershey only – Research involves research-related radiation procedures. All 
research involving radiation procedures (standard of care and/or research-related) must upload a copy 
of HRP-903 - Radiation Review Form on the “Supporting Documents” page in CATS IRB. This form is 
available in the CATS IRB Library.
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE.
  Scientific Review – Hershey only – All investigator-written research studies requiring review by the 
convened IRB must provide documentation of scientific review with the IRB submission. The scientific 
review requirement may be fulfilled by one of the following: (1) external peer-review process; (2) 
department/institute scientific review committee; or (3) scientific review by the Clinical Research Center 
Advisory committee.  NOTE: Review by the Penn State Hershey Cancer Institute Scientific Review 
Committee is required if the study involves cancer prevention studies or cancer patients, records and/or 
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tissues. For more information about this requirement see the IRB website at: 
http://www.pennstatehershey.org/web/irb/home/resources/investigator 
18.0 Multi-Site Research
18.1
Communication Plans
Not a multi-site research project.
18.2
Data Submission and Security Plan
Not a multi-site research project.
18.3
Subject Enrollment
Not a multi-site research project.
18.4
Reporting of Adverse Events and New Information
Not a multi-site research project.
18.5
Audit and Monitoring Plans
Not a multi-site research project.
19.0 Adverse Event Reporting
19.1
Adverse Event Definitions
For drug studies, incorporate the following definitions into the below responses, as written:
Adverse event
Any untoward medical occurrence associated with the use of the drug in 
humans, whether or not considered drug related
Adverse reaction
Any adverse event caused by a drug
Suspected adverse 
reaction
Any adverse event for which there is a reasonable possibility that the drug 
caused the adverse event.  Suspected adverse reaction implies a lesser degree of 
certainty about causality than “adverse reaction”.

Reasonable possibility.  For the purpose of IND safety reporting, 
“reasonable possibility” means there is evidence to suggest a causal 
relationship between the drug and the adverse event.
Serious adverse 
event or Serious 
suspected adverse 
reaction
Serious adverse event or Serious suspected adverse reaction: An adverse event 
or suspected adverse reaction that in the view of either the investigator or 
sponsor, it results in any of the following outcomes: Death, a life-threatening 
adverse event, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant incapacity or substantial disruption of 
the ability to conduct normal life functions, or a congenital anomaly/birth defect. 
Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate 
medical judgment, they may jeopardize the patient or subject and may require 
medical or surgical intervention to prevent one of the outcomes listed in this 
definition. 
Life-threatening 
adverse event or 
life-threatening 
suspected adverse 
reaction
An adverse event or suspected adverse reaction is considered “life-threatening” 
if, in the view of either the Investigator (i.e., the study site principal investigator) 
or Sponsor, its occurrence places the patient or research subject at immediate 
risk of death.  It does not include an adverse event or suspected adverse reaction 
that had it occurred in a more severe form, might have caused death.
Unexpected 
adverse event or 
Unexpected 
An adverse event or suspected adverse reaction is considered “unexpected” if it 
is not listed in the investigator brochure, general investigational plan, clinical 
protocol, or elsewhere in the current IND application; or is not listed at the 
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suspected adverse 
reaction.  
specificity or severity that has been previously observed and/or specified.
For device studies, incorporate the following definitions into the below responses, as written:
Unanticipated 
adverse device 
effect
Any serious adverse effect on health or safety or any life-threatening problem or 
death caused by, or associated with, a device, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or IDE application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects.
19.2
Recording of Adverse Events
All adverse events (serious or non-serious) and abnormal test findings observed or reported to study 
team believed to be associated with the study drug(s) or device(s) will be followed until the event (or its 
sequelae) or the abnormal test finding resolves or stabilizes at a level acceptable to the investigator.
An abnormal test finding will be classified as an adverse event if one or more of the following criteria are 
met:

The test finding is accompanied by clinical symptoms

The test finding necessitates additional diagnostic evaluation(s) or medical/surgical intervention; 
including significant additional concomitant drug treatment or other therapy
NOTE: Simply repeating a test finding, in the absence of any of the other listed criteria, does not 
constitute an adverse event.

The test finding leads to a change in study drug dosing or discontinuation of subject 
participation in the clinical research study
The test finding is considered an adverse event by the investigator.
19.3
Causality and Severity Assessments
The investigator will promptly review documented adverse events and abnormal test findings to 
determine 1) if the abnormal test finding should be classified as an adverse event; 2) if there is a 
reasonable possibility that the adverse event was caused by the study drug(s) or device(s); and 3) if the 
adverse event meets the criteria for a serious adverse event.
If the investigator’s final determination of causality is “unknown and of questionable relationship to the 
study drug(s) or device(s)”, the adverse event will be classified as associated with the use of the study 
drug(s) or device(s) for reporting purposes.  If the investigator’s final determination of causality is 
“unknown but not related to the study drug(s) or device(s)”, this determination and the rationale for the 
determination will be documented in the respective subject’s case history.
19.4
Reporting of Adverse Reactions and Unanticipated Problems to the FDA  
19.4.1 Written IND/IDE Safety Reports
N/A
19.4.2 Telephoned IND Safety Reports – Fatal or Life-threatening Suspected Adverse Reactions
N/A
19.5
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a subject or other individual, which in the opinion of the investigator is determined to be 
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(1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures.
19.6
Unblinding Procedures
The patients will be notified if infections are suspected and will be followed up with appropriate revision 
surgery or any required additional procedures for infections. In such scenario, the patient will be 
unblinded to explain the procedural/cautionary steps taken to address the serious adverse event. 
19.7
Stopping Rules
Patients should stop using the dressing and consult the PI if allergy, irritation, increased pain, 
maceration, or any irregular skin discoloration occurs.
20.0 Study Monitoring, Auditing and Inspecting
20.1
Study Monitoring Plan
20.1.1 Quality Assurance and Quality Control
The investigator will permit study-related monitoring, audits, and inspections by the Penn State 
quality assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all 
study related documents (e.g., source documents, regulatory documents, data collection 
instruments, study data etc.).  The investigator will ensure the capability for inspections of 
applicable study-related facilities (e.g., pharmacy, diagnostic laboratory, etc.).
20.1.2 Safety Monitoring
N/A
21.0 Future Undetermined Research: Data and Specimen Banking
21.1
Data and/or specimens being stored
N/A
21.2
Location of storage
N/A
21.3
Duration of storage
N/A
21.4
Access to data and/or specimens
N/A
21.5
Procedures to release data or specimens
N/A
21.6
Process for returning results
N/A
22.0 References
1. Chow J. Wireless microcurrent-generating antimicrobial wound dressing in primary total knee 
arthroplasty: a single-center experience. Orthop Rev. 2016;8(2):6296.
2. Kim H, Makin I, Skiba J, et al. Antibacterial efficacy testing of a bioelectric wound dressing against 
clinical wound pathogens. Open Microbiol J. 2014;8:15-21.
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3. Lee MJ, Pottinger PS, Butler-Wu S, Bumgarner RE, Russ SM, Matsen FA. Propionibacterium persists in 
the skin despite standard surgical preparation. J Bone Joint Surg Am. 2014;96(17):1447-1450. 
doi:10.2106/JBJS.M.01474
4. Lorenzetti, A, Wongworawat M, Jobe C, Phipatanakul W. Cyanoacrylate microbial sealant may reduce 
the prevalence of positive cultures in revision shoulder arthroplasty. Clin Orthop Relat Res. 2013; 
471(10): 3225-3229
5. Namdari S, Nicholson T, Parvizi J, Ramsey M. Preoperative doxycycline does not decolonize 
Propionibacterium acnes from the skin of the shoulder: a randomized controlled trial. J Shoulder Elbow 
Surg. 2017;26(9):1495-1499. doi:10.1016/j.jse.2017.06.039
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