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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: Completed NA study, sponsored by University of Michigan.
NCT03156543 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
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,
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 |
What the finished NCT03156543 record still lists
NCT03156543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Jumpstart Dressing is the first listed.
NCT03156543 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03156543's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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