Clinical trial NCT03156543: Microcurrent Dressing to Treat Infections, Before, During and After Surgery
Official title: Evaluation of a Microcurrent Dressing for Prophylaxis Against Perioperative Prosthetic Joint Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Arthropathy Associated With Other Conditions
Shoulder Arthritis
Shoulder Osteoarthritis
Shoulder Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2017-05-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Primary outcomes:
measure: Measurement of Change in Cutibacterium Acnes
timeFrame: 2 days pre-operatively and at the time of surgery
Secondary outcomes:
measure: Cosmesis and Apposition
timeFrame: At 7 days and then again 10-14 days postoperatively
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: