Shoulder Arthropathy Associated With Other Conditions, Shoulder Arthritis, Shoulder Osteoarthritis, Shoulder Pain
Conditions
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.
Interventions
DEVICEJumpstart 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
OTHERStandard Dressing
This is a standard of care bandage that will be placed on participants in group A post operatively
Sponsors
Arthrex, Inc.
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| 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 | 23 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Jumpstart Dressing Pre and Post-Operatively | Total | Jumpstart Dressing Pre-Operatively Only |
|---|---|---|---|
| Age, Continuous | 59.64 years STANDARD_DEVIATION 15.92 | 62.29 years STANDARD_DEVIATION 14.86 | 68.78 years STANDARD_DEVIATION 7.54 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 23 participants | 32 participants | 9 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 3 Participants |
| Sex: Female, Male Male | 18 Participants | 24 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 23 |
| other Total, other adverse events | 0 / 9 | 0 / 23 |
| serious Total, serious adverse events | 0 / 9 | 0 / 23 |
Outcome results
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.
Time frame: 2 days pre-operatively and at the time of surgery
Population: Data analyzed only for participants who had both measurements
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Jumpstart Dressing Pre-Operatively Only | Measurement of Change in Cutibacterium Acnes | Moderate Start; Decrease | 1 Participants |
| Jumpstart Dressing Pre-Operatively Only | Measurement of Change in Cutibacterium Acnes | Minimal Start; Decrease | 3 Participants |
| Jumpstart Dressing Pre-Operatively Only | Measurement of Change in Cutibacterium Acnes | Moderate Start; Increase | 0 Participants |
| Jumpstart Dressing Pre-Operatively Only | Measurement of Change in Cutibacterium Acnes | Few start; no change; 2 level increase biopsy only | 0 Participants |
| Jumpstart Dressing Pre-Operatively Only | Measurement of Change in Cutibacterium Acnes | Few Start; Decrease | 0 Participants |
| Jumpstart Dressing Pre-Operatively Only | Measurement of Change in Cutibacterium Acnes | Numerous Start; Decrease | 0 Participants |
| Jumpstart Dressing Pre-Operatively Only | Measurement of Change in Cutibacterium Acnes | No Bacteria at Start; No change | 3 Participants |
| Jumpstart Dressing Pre-Operatively Only | Measurement of Change in Cutibacterium Acnes | Numerous Start; No change | 0 Participants |
| Jumpstart Dressing Pre-Operatively Only | Measurement of Change in Cutibacterium Acnes | Few Start; No change | 0 Participants |
| Jumpstart Dressing Pre-Operatively Only | Measurement of Change in Cutibacterium Acnes | Moderate Start; 3 level decrease; no change biopsy | 1 Participants |
| Jumpstart Dressing Pre-Operatively Only | Measurement of Change in Cutibacterium Acnes | Minimal Start; No change | 1 Participants |
| Jumpstart Dressing Pre and Post-Operatively | Measurement of Change in Cutibacterium Acnes | Moderate Start; 3 level decrease; no change biopsy | 0 Participants |
| Jumpstart Dressing Pre and Post-Operatively | Measurement of Change in Cutibacterium Acnes | No Bacteria at Start; No change | 8 Participants |
| Jumpstart Dressing Pre and Post-Operatively | Measurement of Change in Cutibacterium Acnes | Minimal Start; Decrease | 2 Participants |
| Jumpstart Dressing Pre and Post-Operatively | Measurement of Change in Cutibacterium Acnes | Minimal Start; No change | 2 Participants |
| Jumpstart Dressing Pre and Post-Operatively | Measurement of Change in Cutibacterium Acnes | Few Start; Decrease | 1 Participants |
| Jumpstart Dressing Pre and Post-Operatively | Measurement of Change in Cutibacterium Acnes | Few Start; No change | 1 Participants |
| Jumpstart Dressing Pre and Post-Operatively | Measurement of Change in Cutibacterium Acnes | Moderate Start; Decrease | 3 Participants |
| Jumpstart Dressing Pre and Post-Operatively | Measurement of Change in Cutibacterium Acnes | Moderate Start; Increase | 1 Participants |
| Jumpstart Dressing Pre and Post-Operatively | Measurement of Change in Cutibacterium Acnes | Numerous Start; Decrease | 1 Participants |
| Jumpstart Dressing Pre and Post-Operatively | Measurement of Change in Cutibacterium Acnes | Few start; no change; 2 level increase biopsy only | 1 Participants |
| Jumpstart Dressing Pre and Post-Operatively | Measurement of Change in Cutibacterium Acnes | Numerous Start; No change | 2 Participants |
Comparison: Analysis was based on the participants who were positive for C. acnes.p-value: 0.004Fisher Exact
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
Time frame: 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.