Shoulder Pain Clinical Trial
Official title:
Evaluation of a Microcurrent Dressing for Prophylaxis Against Perioperative Prosthetic Joint Infection
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.
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