NCT03156543

Microcurrent Dressing to Treat Infections, Before, During and After Surgery

Evaluation of a Microcurrent Dressing for Prophylaxis Against Perioperative Prosthetic Joint Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Shoulder Arthropathy Associated With Other Conditions
• Shoulder Arthritis
• Shoulder Osteoarthritis
• Shoulder Pain

Interventions

Type	Name	Description
DEVICE	Jumpstart Dressing	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. It will be applied pre-op in all patients and post operatively in group B
OTHER	Standard Dressing	This is a standard of care bandage that will be placed on participants in group A post operatively

Timeline

• Start date: 2017-04-19
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2017-05-17
• Last updated: 2020-10-09
• Results posted: 2020-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study