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Unexpected culture contamination potentially due to a testing error
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The objective of the study is to evaluate the efficacy of preoperative treatment with a novel, wireless, low-level microcurrent-generating antimicrobial device (brand name: JumpStart) in preventing the spread of Propionibacterium acnes in patients receiving open or arthroscopic shoulder surgery.
The spread of multi-drug resistant bacteria and financial burden of periprosthetic joint infection exacerbate the need for treatments to address pathogenic contamination and expedite healing. Although rare, these infections can place a great financial burden on the health care system and are often associated with increased hospital length of stay, compromised function, reduced quality of living, and increased likelihood of follow-up surgeries. Bacterial infection can further compound this problem with the widespread, prolonged use of prolonged antimicrobial prophylaxis. It is know that there is a high frequency of infections after open and arthroscopic shoulder surgery caused by Propionibacterium acnes. Because P. acnes normally colonizes under the epidermal layer in sebaceous glands, topical skin preparations, skin cleansers, and antibiotics may be unable to completely penetrate the deep layers of the skin to eradicate its colonization in all layers of the skin.
A novel, wireless, low-level microcurrent-generating antimicrobial device has been observed, in vitro, to exhibit electricidal effect in the presence of antibiotic and multidrug resistant clinical wound isolates. These energy-based systems were originally employed to augment wound healing process, reduce infection, and address edema and pain in the recent decades. Low-level microcurrents have been recently expanded into the orthopedic space as a bacterial growth inhibitor both in vitro and in vivo. Procellera (JumpStart) is a sterile single layer dressing consisting of a matrix of alternating silver (Ag) and zinc (Zn) dots that are held in positions on a polyester substrate with biocompatible binder. Dressing is then activated in the presence of a conductive fluid, which may come from wound exudate or exogenous fluids, such as saline.
Many studies have been done already on the wound healing and pain management properties of JumpStart, but only few have explored its bactericidal properties. To date, no MRSA strains have been found to possess Ag-resistant genes, and there is no known mechanism of bacterial resistance to all heavy metal ions. However, studies have suggested that the widespread and uncontrolled use of Ag+ in wound care may result in more bacteria developing resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JumpStart group | Experimental | This group will have the JumpStart dressing pre-operatively. Intervention: JumpStart dressing |
|
| Control group | No Intervention | This group will have no intervention pre-operatively. Intervention: none |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JumpStart Antimicrobial Wound Dressing | Device | A novel, wireless, low-level microcurrent-generating antimicrobial device (JumpStart) is a sterile single layer dressing consisting of a matrix of alternating silver (Ag) and zinc (Zn) dots that are held in positions on a polyester substrate with biocompatible binder. Dressing is then activated in the presence of a conductive fluid, which may come from wound exudate or exogenous fluids, such as saline. It has been observed, in vitro, to exhibit electricidal effect in the presence of antibiotic and multidrug resistant clinical wound isolates. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Propionibacterium Acnes in Skin Biopsies During Surgery | The primary outcome measures the intraoperative culture results (e.g. positive vs negative, days to positive conversion) for P. acnes by evaluating bacterial cultures from punch skin biopsies at the time of the surgery. | 7 days post-biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyunmin Kim, MD | Penn State Bone and Joint Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Bone and Joint Institute | Hershey | Pennsylvania | 17033 | United States |
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17 participants met inclusion criteria and were enrolled. 3 participants withdrew prior to study intervention.
Participants were recruited in the Penn State Health Orthopedics Clinic for indications of open or arthroscopic shoulder surgery.
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Enrolled participants served as their own control. The surgical shoulder served as the Treatment Shoulder with the Jumpstart dressing intervention, while the normal non-operative contralateral shoulder served as the Control Shoulder. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Enrolled participants served as their own control, where both shoulders of each participant will be included for the study. The surgical side shoulder will serve as a Treatment Shoulder with the Jumpstart dressing intervention, while the normal non-operative contralateral shoulder will serve as a Control Shoulder.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Enrolled participants served as their own control. The surgical shoulder served as the Treatment Shoulder with the Jumpstart dressing intervention, while the normal non-operative contralateral shoulder served as the Control Shoulder. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Presence of Propionibacterium Acnes in Skin Biopsies During Surgery | The primary outcome measures the intraoperative culture results (e.g. positive vs negative, days to positive conversion) for P. acnes by evaluating bacterial cultures from punch skin biopsies at the time of the surgery. | Data not analyzed due to unexpected culture contamination. | Posted | 7 days post-biopsy |
|
up to 7 days post shoulder surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JumpStart Group | This group will have the JumpStart dressing pre-operatively. Intervention: JumpStart dressing JumpStart Antimicrobial Wound Dressing: A novel, wireless, low-level microcurrent-generating antimicrobial device (JumpStart) is a sterile single layer dressing consisting of a matrix of alternating silver (Ag) and zinc (Zn) dots that are held in positions on a polyester substrate with biocompatible binder. Dressing is then activated in the presence of a conductive fluid, which may come from wound exudate or exogenous fluids, such as saline. It has been observed, in vitro, to exhibit electricidal effect in the presence of antibiotic and multidrug resistant clinical wound isolates. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hyunmin Kim | Penn State Health | 717-531-4826 | hkim2@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2019 | Nov 22, 2019 | Prot_SAP_000.pdf |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Enrolled participants served as their own control, where both shoulders of each participant will be included for the study. The surgical side shoulder will serve as a Treatment Shoulder with the Jumpstart dressing intervention, while the normal non-operative contralateral shoulder will serve as a Control Shoulder. | Number | participants |
|
| OG001 | Control Group | This group will have no intervention pre-operatively. Intervention: none |
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Control Group | This group will have no intervention pre-operatively. Intervention: none | 0 | 17 | 0 | 17 | 0 | 17 |
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