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

NCT03156543 | Completed Results DMC FDA Device

• 1 other identifier: HUM00109957
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Measurement of Change in Cutibacterium Acnes

  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.

  2 days pre-operatively and at the time of surgery

Secondary Outcomes (1)

• Cosmesis and Apposition

  At 7 days and then again 10-14 days postoperatively

Study Arms (2)

Group A

EXPERIMENTAL

This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively.

Device: Jumpstart Dressing; Other: Standard Dressing

Group B

EXPERIMENTAL

This group will have the jumpstart dressing pre-operatively and a jumpstart dressing post operatively.

Device: Jumpstart Dressing

Interventions

Jumpstart Dressing DEVICE

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

Group A; Group B

Standard Dressing OTHER

This is a standard of care bandage that will be placed on participants in group A post operatively

Also known as: Gauze

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bethany Ruffino
• Organization: University of Michigan Medical School

bruffino@med.umich.edu

734 615-0768

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-Associate Professor

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 17, 2017
• Study Start: April 19, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)