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

Not Applicable

Completed

• Conditions: Shoulder Pain; Shoulder Arthropathy Associated With Other Conditions; Shoulder Arthritis; Shoulder Osteoarthritis
• Interventions: Device: Jumpstart Dressing; Other: Standard Dressing

• Registration Number: NCT03156543
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-19
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2020-09
• Results First Submitted: 2020-09-16
• Results First Submitted QC: 2020-09-16
• Last Update Submitted: 2020-09-16
• Results First Posted: 2020-10-09
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Limited to total or reverse shoulder arthroplasty
• All patients 18 years of age and older

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Exclusion Criteria

• Under the age of 18
• Revision shoulder arthroplasty patients
• Sensitivity or allergy to sliver or zinc or latex

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Jumpstart Dressing	This group will have the jumpstart dressing pre-operatively and a jumpstart dressing post operatively.
Group A	Jumpstart Dressing	This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively.
Group A	Standard Dressing	This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively.

Primary Outcome Measures

Name	Time	Method
Measurement of Change in Cutibacterium Acnes	2 days pre-operatively and at the time of surgery	All topical and deep tissue specimens were planned to be cultured for Propionibacterium Acnes. The type and number of colony forming units (CFU) will be recorded. Propionibacterium was renamed during the course of the trial, so the actual bacteria culture was Cutibacterium.; Swabs for topical bacteria collections were taken 48 hours apart; biopsies to check on bacterial depth were taken at time of surgery.; Bacteria CFU counts were classified into 5 categories: None, Minimal, (1-5 colonies) Few, (6-15 colonies) Moderate (16-99 colonies) and Numerous (100 or greater).; Participants are categorized by their initial count categories and their change (expressed as reduction, no change, or increase) in CFU count (categorized) as measured by skin swabs; Biopsy count category discrepancies from time of surgery swab are only shown if they were a more than 1 category difference.

Secondary Outcome Measures

Name	Time	Method
Cosmesis and Apposition	At 7 days and then again 10-14 days postoperatively	Investigator determined from a small number of collected images that because of the number of arthroscopies rather than arthroplasties performed, the surgical wound was not large enough to evaluate the wound healing effect of dressings. Photo collection was discontinued and that data was not analyzed

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States