Evaluation of a Microcurrent Dressing for Prophylaxis Against Perioperative Prosthetic Joint Infection
Phase: NA
Conditions: Shoulder Arthropathy Associated With Other Conditions, Shoulder Arthritis, Shoulder Osteoarthritis, Shoulder Pain
Sponsor: University of Michigan

 
 
Microcurrent Dressing to Treat Infections, Before, During and After Surgery  
 
NCT03156543 
 
 
2018-01-05 
 

Evaluation of a Microcurrent Dressing for Prophylaxis Against  
Perioperative Prosthetic Joint Infection 
 
PI: Bruce Miller, MD  
 
Co-Is: Asheesh Bedi, Margaret Paulauski, Brian Downie, Tristan Maerz 
 
Study personnel: Elizabeth Sibilsky Enselman, Jaimee Gauthier 
 
 
Lay Explanation 
 
     The purpose of the study is to evaluate the efficacy of a microcurrent dressing in eliminating 
certain bacteria that is found on our skin, thus it would reduce the risk of shoulder infections.  
 
 
     Deep periprosthetic infection following total joint arthroplasty is a major complication.  
Although it only occurs in a small percentage of patients (~1%), it results in substantial 
complications and a decline in functional outcome. A two stage revision and exchange is 
commonly required in order to clear the infection and provide the best opportunity for prosthetic 
replantation.   
 
 
Propionibacterium Acnes is bacteria that are found in hair follicles, sebaceous glands, and 
moist areas of the shoulder and armpit. Because of its low virulence, infections caused by P. 
acnes typically have a low-grade, slow course, with shoulder pain often the only presenting 
symptoms after prosthetic replacement.  P. acnes is particularly challenging to both diagnose and 
to eradicate, and is a substantial source of low quality and functional outcomes with shoulder 
arthroplasty.   
 
 
JumpStart™ is a wireless, advanced microcurrent generating dressing used for the 
management of surgical incision sites. Microcell batteries made of silver and zinc, generate an 
electrical current when activated by conductive fluids, such as saline, hydrogel or bodily fluids 
from a wound. These microcells create low voltage electrical fields to stimulate the surrounding 
area and to provide antimicrobial protection to assist with wound healing. JumpStart has 
demonstrated superior broad spectrum bactericidal activity of a wound dressing against 
antibiotic-resistant strains of wound isolates within 24 hours. 
 
 

 
 
The use of JumpStart as a prophylactic preoperative and post-operative dressing to alter the 
skin flora and thereby decrease the risk of prosthetic infection has not been investigated to-date. 
Given the morbidity of a prosthetic infection, this would be a remarkably valuable intervention 
for any joint replacement procedure.  
 
Background 
 
 
Deep periprosthetic infection following total joint arthroplasty is a major complication.  
Although it only occurs in a small percentage of patients (~1%), it results in substantial 
morbidity and a decline in functional outcome. A two stage revision and exchange is commonly 
required in order to clear the infection and provide the best opportunity for prosthetic 
replantation.  Following removal of the infected components, a minimum course of six weeks of 
parenteral antibiotics is given and resolution of the infection confirmed through the ESR, CRP, 
and repeated aspiration of the joint. In most instances a temporary spacer of antibiotic-loaded 
cement is inserted at the first stage and removed at the second operation. 
 
 
Propionibacterium Acnes is a gram-positive, non-spore-forming, anaerobic bacillus found in 
lipid-rich areas, including hair follicles, sebaceous glands, and moist areas of the shoulder and 
axilla.  Because of its low virulence, infections caused by P. acnes typically have a low-grade, 
indolent course, with shoulder pain often the only presenting symptoms after prosthetic 
replacement.  P. acnes is particularly challenging to both diagnose and to eradicate, and is a 
substantial source of morbidity with shoulder arthroplasty.   
 
 
JumpStart™ is a wireless, advanced microcurrent generating, dressing used for the 
management of surgical incision sites. Microcell batteries made of silver and zinc, generate an 
electrical current when activated by conductive fluids, such as saline, hydrogel or wound 
exudate. These microcells create low voltage electrical fields to stimulate the surrounding area 
and to provide antimicrobial protection to assist with wound healing. JumpStart has 

demonstrated superior broad spectrum bactericidal activity of a wound dressing against 
antibiotic-resistant strains of wound isolates within 24 hours. 
 
 
The use of JumpStart as a prophylactic preoperative dressing to alter the skin flora and 
thereby decrease the risk of prosthetic infection has not been investigated to-date. Given the 
morbidity of a prosthetic infection, this would be a remarkably valuable intervention for any 
joint replacement procedure.  
 
Due to lower than expected accrual, the addition of arthroscopic shoulder surgery patients will 
still allow the study of the JumpStart dressing and the efficacy of eliminating P. acnes in a board 
patient population.  
 
Objective: To evaluate the efficacy of a microcurrent dressing in eliminating P. acnes skin 
colonization and thereby reduce the risk of perioperative prosthetic shoulder infection. 
 
Overall Study Design.  This is a prospective cohort study of patients that are scheduled to have a 
total or reverse shoulder arthroplasty or arthroscopic shoulder surgery. There will be two groups 
for this study. Both groups will follow the same timeline below.  
 
Group A: With the exception of the preoperative JumpStart dressing and cultures for assessment 
of P. acnes which will be paid for with department funds the study does not deviate from the 
standard of care typically provided to patients seeking treatment for a total or reverse shoulder 
arthroplasty or arthroscopic shoulder surgery within the University of Michigan Health System, 
and is in line with national and international standards of care. 
 
Group B: With the exception of the preoperative and postoperative JumpStart dressing and 
cultures for assessment of P. acnes which will be paid for with department funds the study does 
not deviate from the standard of care typically provided to patients seeking treatment for a total 
or reverse shoulder or arthroscopic shoulder surgery arthroplasty within the University of 
Michigan Health System, and is in line with national and international standards of care. 
 
An overview of the timeline of study visits is presented in Table 1.  
 
Study Visit 
Approx. Time 
from Initial 
Visit 
Measures Performed 
Study Enrollment Visit/ H&P Visit 
-4wks to -
1wks prior to 
surgery 
Consent 
Research Visit 
-2d 
Placement of JumpStart dressing, skin 
culture 
Surgery 
0 
Skin culture and biopsy; Group B 
Postoperative JumpStart dressing applied 
Post-op Research Visit 
7 days 
Removal of dressing for both groups, 
images of incision and reapplication of 

dressings for both groups that was applied 
at time of surgery 
Post-op Visit 
10-14d 
Skin culture, images of incision 
Table 1.  Timeline of study visits and measures performed in study.   
 
 
Subject Selection and Recruitment. The inclusion criteria will be strictly limited to total or 
reverse shoulder arthroplasty or arthroscopic shoulder surgery . Exclusion criteria- under the age 
of 18, revision shoulder arthroplasty patients, sensitivity or allergy to sliver or zinc or latex.  
 
Patients will be recruited from clinic in Orthopaedic Surgery.  Patients who seek treatment and 
who are deemed to be potential candidates for a total or reverse shoulder arthroplasty or 
arthroscopic shoulder surgery will be approached to participate in the research study.  
 
 
JunpStart Dressing. Groups A and B will have the dressing applied 2 days prior to surgery 
by a member of the research team. Sterile saline will be used to moisten the dressing. Group B 
then will have the dressing again applied at the conclusion of surgery. This will be done using 
routine UM surgical OR protocols. Both groups will report for a research visit 7 days after 
surgery for a dressing check. Group B will have another JumpStart dressing reapplied until they 
report back for their first PO visit 10-14 days after surgery. Group A will have the same type of 
dressing reapplied that was placed on after surgery.    
 
 
 
Measurement of P.Acnes.  Twenty patients scheduled for total or reverse shoulder 
arthroplasty or arthroscopic shoulder surgery will have a topical skin culture in duplicate at the 
site of the deltopectoral incision 48 hours before the surgical procedure.  Then a Jumpstart 
dressing will be applied to the deltopectoral incision site and left in place until intraoperative 
preparation and draping for the surgical procedure.  Prior to preparation with chlorhexidine, a 
topical skin culture will be taken in duplicate. The skin will then be prepared for surgery in the 
standard fashion, and the deltopectoral incision will be made. A small biopsy from the edge will 
be taken for deep tissue culture and evaluation.   
 
 
All topical and deep tissue specimens will be cultured for aerobic and anaerobic cultures, 
including specific culture for Propionibacterium Acnes.  The type and number of colony forming 
units (CFU) will be recorded.  
 
 
Chart Review. Patients’ chart will be monitored for clinical outcomes related to shoulder 
surgery and any cases of acute, subacute, or chronic prosthetic infection and will be recorded for 
a minimum of a year postoperatively. 
 
 
 
Images. At 7 and then again 10-14 day postoperatively, the wound will be inspected and 
images will be obtained to evaluate cosmesis and apposition. Care will be taken to protect 
subject’s privacy.   
 
 
Group Assignment. Subjects will be randomly assigned to either group A or B. There will be 
a 50% chance of being assigned to either group.  
 
 

 
 
 
Risks 
The risks associated with the research study include:  
 
Skin Cultures and Biopsy: There are no risks related to the skin cultures. These are taken 
topically. The skin biopsy will be taken prior to incision closure and should not cause extra 
scaring as it will be taken form the margin of the incision.   
 
JumpStart Dressing: Should not be use on individuals with sensitivity or allergy to silver, zinc, 
latex. MRI Non Compatible: Neither MRI Safe nor MRI Compatible and should not be used in 
conjunction with MRI systems. Frequent or prolonged use of this product may result in 
permanent discoloration of the skin (i.e. argyria). The use of adhesive dressings on fragile or 
sensitive skin may pose a risk of skin damage upon removal of the dressing. The patient should 
stop using the dressing and consult a physician if allergy, irritation, increased pain, maceration or 
any irregular skin discoloration occurs. 
 
Confidentiality: 
There is a small risk of breach of confidentiality. Your research data will not leave the University 
of Michigan medical campus (Ann Arbor, MI).Data and images will be retained until data related 
to the research is published at which time all the materials will be destroyed. 
 
As with any research study, there may be additional risks that are unknown or unexpected. 
 
Data Safety Monitoring Plan 
 
The risk level indicated for this study is no more than minimal risk.  All study team members 
including PI, Co-Is, study coordinators, and research assistants will obtain informed consent, and 
will provide study information and instructions to the subjects beyond what is included in the 
informed consent document, and will collect and record study data. 
 
Adverse events will be reported to the IRB using the standard IRBMED AE reporting timetable, 
utilizing the generalized AE grading scale: 
0 - No adverse event 
1 - Mild AE: No treatment needed 
2 - Moderate AE: Resolved with treatment 
3 - Severe AE: Inability to carry on normal activities, required professional medical attention 
4 - Life-threatening or disabling AE  
 
5 - Fatal AE 
 
Serious Adverse Events (SAEs) will be categorized according to the following FDA definition: 
- Death 
- A life-threatening adverse drug experience 
- Inpatient hospitalization or prolongation of existing hospitalization 
- A persistent or significant disability/incapacity 

- A congenital anomaly/birth defect 
- Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered a serious adverse drug experience 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.  
 
The PI and/or Co-I will determine the attribution/relatedness for each AE in the following 
manner: 
- Definitely related 
- Probably related 
- Possibly related 
- Unlikely to be related 
- Definitely not related 
 
The expectedness will be assigned for each AE according to the following definitions: 
Unexpected adverse events (i.e., has NOT been addressed or described in one or more of the 
following: Informed consent document(s) for this study, IRB application for this study, protocol 
or procedures for this study, published literature, other documentation) 
 
Expected adverse events (i.e., has been addressed or described in one or more of the following: 
Informed consent document(s) for this study, IRB application for this study, protocol or 
procedures for this study, published literature, other documentation, or characteristics of the 
study population) 
 
The frequency with which the study team will conduct scheduled assessments of study 
recruitment, data integrity and quality, adverse events, withdrawals, and compliance with 
protocol plan will be on a quarterly basis because this is a minimal risk study. No additional 
monitoring is required – the nature, size, and complexity of this study does not require additional 
safety monitoring to that provided by the IRB.  Monitoring reports will be provided to the IRB. 
 
 
 
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