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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156543
• Other study ID #: HUM00109957
• Status: Completed
• Phase: N/A
• Start date: April 19, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: September 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Limited to total or reverse shoulder arthroplasty

• All patients 18 years of age and older

Exclusion Criteria:

• Under the age of 18

• Revision shoulder arthroplasty patients

• Sensitivity or allergy to sliver or zinc or latex

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Arthrex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cosmesis and Apposition	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	At 7 days and then again 10-14 days postoperatively