Shoulder Arthropathy Associated With Other ConditionsNCT03156543
Microcurrent Dressing to Treat Infections, Before, During and After Surgery
A study testing Jumpstart Dressing and Standard Dressing in people with Shoulder Arthropathy Associated With Other Conditions and Shoulder Arthritis, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthropathy Associated With Other Conditions, Shoulder Arthritis, Shoulder Osteoarthritis
- What is being tested?
- Jumpstart Dressing and Standard Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2017to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Limited to total or reverse shoulder arthroplasty
- All patients 18 years of age and older
Who cannot join
- Under the age of 18
- Revision shoulder arthroplasty patients
- Sensitivity or allergy to sliver or zinc or latex
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Microcurrent Dressing for Prophylaxis Against Perioperative Prosthetic Joint Infection
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.
Read more
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
- Being tested
- Jumpstart Dressing, Standard Dressing
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jumpstart DressingDevice
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 DressingOther
Also called Gauze
This is a standard of care bandage that will be placed on participants in group A post operatively
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively. Receives: Device: Jumpstart Dressing; Other: Standard Dressing |
| Group B | Experimental | This group will have the jumpstart dressing pre-operatively and a jumpstart dressing post operatively. Receives: Device: Jumpstart Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days pre-operatively and at the time of surgery
Secondary outcomes (1)
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
Measured: At 7 days and then again 10-14 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start19 Apr 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder Arthropathy Associated With Other ConditionsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Principal investigator, Bruce Miller, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156543
- Sponsor's protocol ID
- HUM00109957
- Status last verified
- Sep 2020
- First submitted
- 8 May 2017
- Last updated
- 9 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Microcurrent Dressing for Prophylaxis Against Perioperative Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT03156543
- Acronym / sponsor ID
- HUM00109957
- Conditions
- Shoulder Arthropathy Associated With Other Conditions, Shoulder Arthritis, Shoulder Osteoarthritis, Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Posted 9 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Jumpstart Dressing, Other: Standard DressingThis group will have the jumpstart dressing pre-operatively and a standard dressing post operatively. |
| Group B | Experimental | Device: Jumpstart DressingThis group will have the jumpstart dressing pre-operatively and a jumpstart dressing post operatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Limited to total or reverse shoulder arthroplasty
- All patients 18 years of age and older
Key exclusion criteria (3 listed)
- Under the age of 18
- Revision shoulder arthroplasty patients
- Sensitivity or allergy to sliver or zinc or latex
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jumpstart DressingJumpStart™ 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 | Device | Group A, Group B |
| Standard DressingAlso: GauzeThis is a standard of care bandage that will be placed on participants in group A post operatively | Other | Group A |
Primary outcome
Measurement of Change in Cutibacterium Acnes
Time frame: 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.
1 secondary outcome
Cosmesis and Apposition
Time frame: At 7 days and then again 10-14 days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jumpstart Dressing and Standard Dressing in people with Shoulder Arthropathy Associated With Other Conditions and Shoulder Arthritis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Change in Cutibacterium Acnes (time frame: 2 days pre-operatively and at the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.