Clinical Trial: Microcurrent Dressing to Treat Infections, Before, During and After Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: University of Michigan

Current Primary Outcome: Measurement of change in Propionibacterium Acnes [ Time Frame: 2 days pre-operatively and at the time of surgery ]

All topical and deep tissue specimens will be cultured for Propionibacterium Acnes. The type and number of colony forming units (CFU) will be recorded.


Original Primary Outcome: Same as current

Current Secondary Outcome: Cosmesis and Apposition [ Time Frame: At 7 days and then again 10-14 days postoperatively ]

The aesthetic appearance of the wound will be inspected and images will be obtained to evaluate.


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: May 8, 2017
Date Started: April 19, 2017
Date Completion: March 1, 2019
Last Updated: May 15, 2017
Last Verified: May 2017