Microcurrent Dressing to Treat Infections, Before, During... | NCT03156543

Microcurrent Dressing to Treat Infections, Before, During... | NCT03156543 | Trialant

Sponsor/Collaborators Module

Name	Class
Arthrex, Inc.	INDUSTRY

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan		Ann Arbor	Michigan	48109	United States

Arm/Group Information

ID	Title	Description
FG000	Jumpstart Dressing Pre-Operatively Only	This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively. 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 Standard Dressing: This is a standard of care bandage that will be placed on participants in group A post operatively
FG001	Jumpstart Dressing Pre and Post-Operatively	This group will have the jumpstart dressing pre-operatively and a jumpstart dressing post operatively. 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

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0009 subjects FG00123 subjects
COMPLETED		FG0008 subjects FG00123 subjects
NOT COMPLETED		FG0001 subjects FG0010 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Jumpstart Dressing Pre-Operatively Only	This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively. 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 Standard Dressing: This is a standard of care bandage that will be placed on participants in group A post operatively

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Data analyzed only for participants who had both measurements

Posted

Count of Participants

Participants

2 days pre-operatively and at the time of surgery

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Jumpstart Dressing Pre-Operatively Only	This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively. 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 Standard Dressing: This is a standard of care bandage that will be placed on participants in group A post operatively

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Bethany Ruffino	University of Michigan Medical School	734 615-0768		bruffino@med.umich.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 5, 2018	Aug 25, 2020	Prot_000.pdf

Condition Browse Module

ID	Term
D020069	Shoulder Pain

ID	Term
D018771	Arthralgia
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D010146	Pain

Race and Ethnicity Not Collected

Race and Ethnicity were not collected from any participant.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
No Bacteria at Start; No change	OG0003 OG0018
Minimal Start; Decrease	OG0003 OG0012
Minimal Start; No change	OG0001 OG0012
Few Start; Decrease	OG0000 OG0011
Few Start; No change	OG0000 OG0011
Moderate Start; Decrease	OG0001 OG0013
Moderate Start; Increase	OG0000 OG0011
Numerous Start; Decrease	OG0000 OG0011
Numerous Start; No change	OG0000 OG0012
Few start; no change; 2 level increase biopsy only	OG0000 OG0011
Moderate Start; 3 level decrease; no change biopsy	OG0001 OG0010

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Analysis was based on the participants who were positive for C. acnes.	Fisher Exact		0.004														Superiority

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

The original Principal Investigator had determined from a small number images that photos did not demonstrate sufficient differentiation to evaluate effect of dressings. The co-investigator who became the Principal Investigator neither resumed photo collection, nor analyzed those taken.

Posted

At 7 days and then again 10-14 days postoperatively

ID	Title	Description
OG000	Jumpstart Dressing Pre-Operatively Only	This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively. 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 Standard Dressing: This is a standard of care bandage that will be placed on participants in group A post operatively
OG001	Jumpstart Dressing Pre and Post-Operatively	This group will have the jumpstart dressing pre-operatively and a jumpstart dressing post operatively. 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

Units	Counts
Participants	OG0000 OG0010