Trial Outcomes & Findings for Microcurrent Dressing to Treat Infections, Before, During and After Surgery (NCT NCT03156543)

NCT ID: NCT03156543

Last Updated: 2020-10-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: 2 days pre-operatively and at the time of surgery
• Results posted on: 2020-10-09

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	9	23
Overall Study COMPLETED	8	23
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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	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
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Jumpstart Dressing Pre-Operatively Only n=9 Participants 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	Jumpstart Dressing Pre and Post-Operatively n=23 Participants 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	Total n=32 Participants Total of all reporting groups
Age, Continuous	68.78 years STANDARD_DEVIATION 7.54 • n=9 Participants	59.64 years STANDARD_DEVIATION 15.92 • n=23 Participants	62.29 years STANDARD_DEVIATION 14.86 • n=32 Participants
Sex: Female, Male Female	3 Participants n=9 Participants	5 Participants n=23 Participants	8 Participants n=32 Participants
Sex: Female, Male Male	6 Participants n=9 Participants	18 Participants n=23 Participants	24 Participants n=32 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	23 participants n=23 Participants	32 participants n=32 Participants

PRIMARY outcome

Timeframe: 2 days pre-operatively and at the time of surgery

Population: Data analyzed only for participants who had both measurements

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.

Outcome measures

Measure	Jumpstart Dressing Pre-Operatively Only n=9 Participants 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	Jumpstart Dressing Pre and Post-Operatively n=22 Participants 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
Measurement of Change in Cutibacterium Acnes No Bacteria at Start; No change	3 Participants	8 Participants
Measurement of Change in Cutibacterium Acnes Minimal Start; Decrease	3 Participants	2 Participants
Measurement of Change in Cutibacterium Acnes Minimal Start; No change	1 Participants	2 Participants
Measurement of Change in Cutibacterium Acnes Few Start; Decrease	0 Participants	1 Participants
Measurement of Change in Cutibacterium Acnes Few Start; No change	0 Participants	1 Participants
Measurement of Change in Cutibacterium Acnes Moderate Start; Decrease	1 Participants	3 Participants
Measurement of Change in Cutibacterium Acnes Moderate Start; Increase	0 Participants	1 Participants
Measurement of Change in Cutibacterium Acnes Numerous Start; Decrease	0 Participants	1 Participants
Measurement of Change in Cutibacterium Acnes Numerous Start; No change	0 Participants	2 Participants
Measurement of Change in Cutibacterium Acnes Few start; no change; 2 level increase biopsy only	0 Participants	1 Participants
Measurement of Change in Cutibacterium Acnes Moderate Start; 3 level decrease; no change biopsy	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At 7 days and then again 10-14 days postoperatively

Population: 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.

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

Outcome measures

Outcome data not reported

Adverse Events

Jumpstart Dressing Pre-Operatively Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Jumpstart Dressing Pre and Post-Operatively

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bethany Ruffino

University of Michigan Medical School

Phone: 734 615-0768

Email: bruffino@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place