N/A
N=32
Microcurrent Dressing to Treat Infections, Before, During and After Surgery
Shoulder Arthropathy Associated With Other Conditions · Shoulder Arthritis · Shoulder Osteoarthritis · Shoulder Pain
Bottom Line
View on ClinicalTrials.gov: NCT03156543 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Measurement of Change in Cutibacterium Acnes — 3; 8; 3; 2 Participants — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Jumpstart Dressing (Device); Standard Dressing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Change in Cutibacterium Acnes |
3; 8; 3; 2; 1; 2 | 0.004 sig |
| SECONDARY Cosmesis and Apposition |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Limited to total or reverse shoulder arthroplasty
- All patients 18 years of age and older
Exclusion Criteria
- Under the age of 18
- Revision shoulder arthroplasty patients
- Sensitivity or allergy to sliver or zinc or latex
Data sourced from ClinicalTrials.gov (NCT03156543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.