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NCT03156543 · ClinicalTrials.gov registry record · NA
Microcurrent Dressing to Treat Infections, Before, During and After Surgery
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT03156543 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 32 participants.
The verdict
NCT03156543, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study 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
Interventions
- DEVICE Jumpstart Dressing
- OTHER Standard Dressing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-04-19 |
| Est. Completion | 2019-10-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03156543
The ClinicalTrials.gov registry entry for NCT03156543 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Jumpstart Dressing is the first listed.
NCT03156543 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03156543 about?
NCT03156543 is a clinical study titled "Microcurrent Dressing to Treat Infections, Before, During and After Surgery". 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 clea...
What is the current status of trial NCT03156543?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2017-04-19. Estimated completion is 2019-10-01.
What interventions are being tested in trial NCT03156543?
The interventions under investigation include: Jumpstart Dressing (DEVICE), Standard Dressing (OTHER).
Who is sponsoring clinical trial NCT03156543?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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