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Trial record 65 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

Microcurrent Dressing to Treat Infections, Before, During and After Surgery

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ClinicalTrials.gov Identifier: NCT03156543
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
Bruce Miller, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Shoulder Arthropathy Associated With Other Conditions Shoulder Arthritis Shoulder Osteoarthritis Shoulder Pain Device: Jumpstart Dressing Other: Standard Dressing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of a Microcurrent Dressing for Prophylaxis Against Perioperative Prosthetic Joint Infection
Actual Study Start Date : April 19, 2017
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively.
Device: 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


Other: Standard Dressing
This is a standard of care bandage that will be placed on participants in group A post operatively
Other Name: Gauze

Experimental: Group B
This group will have the jumpstart dressing pre-operatively and a jumpstart dressing post operatively.
Device: 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





Primary Outcome Measures :
  1. Measurement of change in Propionibacterium Acnes [ Time Frame: 2 days pre-operatively and at the time of surgery ]
    All topical and deep tissue specimens will be cultured for Propionibacterium Acnes. The type and number of colony forming units (CFU) will be recorded.


Secondary Outcome Measures :
  1. Cosmesis and Apposition [ Time Frame: At 7 days and then again 10-14 days postoperatively ]
    The aesthetic appearance of the wound will be inspected and images will be obtained to evaluate.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156543


Contacts
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Contact: Bethany Ruffino, LPN 734-615-0768 bruffino@med.umich.edu
Contact: Jaimee Gauthier, BA 734-647-0050 jaimeeg@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Liz Enselman, MEd, ATC    734-615-0768    esibilsk@med.umich.edu   
Sub-Investigator: Asheesh Bedi, MD         
Sponsors and Collaborators
University of Michigan
Arthrex, Inc.

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Responsible Party: Bruce Miller, MD-Associtate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03156543     History of Changes
Other Study ID Numbers: HUM00109957
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Arthralgia
Pain
Neurologic Manifestations
Signs and Symptoms