- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03156543
Microcurrent Dressing to Treat Infections, Before, During and After Surgery
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively.
|
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
This is a standard of care bandage that will be placed on participants in group A post operatively
Other Names:
|
Experimental: Group B
This group will have the jumpstart dressing pre-operatively and a jumpstart dressing post operatively.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
2 days pre-operatively and at the time of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cosmesis and Apposition
Time Frame: At 7 days and then again 10-14 days postoperatively
|
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
|
At 7 days and then again 10-14 days postoperatively
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00109957
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shoulder Pain
-
Helping Hand Institute of Rehabilitation SciencesRecruitingShoulder Injuries | Shoulder Capsulitis | Shoulder Arthritis | Shoulder Impingement | Shoulder Bursitis | Shoulder Pain ChronicPakistan
-
Şeyhmus KAPLANCompletedSubacromial Impingement | Pain, Shoulder
-
Oslo University HospitalUnknownShoulder Impingement Syndrome | Subacromial Shoulder PainNorway
-
University of Southern DenmarkRegion of Southern Denmark; The Danish Rheumatism Association; Esbjerg Municipality and other collaboratorsCompletedHypermobility Syndrome Shoulder | Shoulder Pain Chronic | Shoulder LuxationDenmark
-
Istanbul University - Cerrahpasa (IUC)Istanbul Aydın UniversityCompletedPain, Shoulder | Myofacial Pain | Adhesion; ShoulderTurkey
-
Mohamed R El TahanCompletedUnilateral Chronic Shoulder Pain | Bilateral Chronic Shoulder PainEgypt
-
Hasan Kalyoncu UniversityHacettepe UniversityCompletedShoulder Pain | Shoulder Injury | Shoulder ImpingementTurkey
-
Helping Hand Institute of Rehabilitation SciencesCompletedShoulder Injuries | Shoulder Pain | Shoulder Capsulitis | Frozen Shoulder | Shoulder ImpingementPakistan
-
Zimmer BiometEnrolling by invitationShoulder Injuries | Shoulder Pain | Shoulder Fractures | Shoulder Arthritis | Shoulder DiseaseUnited States
-
Makassed General HospitalRecruiting
Clinical Trials on Jumpstart Dressing
-
University of WashingtonNational Institute on Aging (NIA)CompletedLiver Cirrhosis | Neoplasm Metastasis | Pulmonary Disease, Chronic Obstructive | Dementia | Kidney Failure, Chronic | Chronic Disease | Peripheral Vascular Disease | Lung Diseases, Interstitial | Health Communication | Lung Neoplasm | Heart Failure,Congestive | Patient Care | Health Care Quality, Access, and Evaluation and other conditionsUnited States
-
Milton S. Hershey Medical CenterTerminatedShoulder Arthropathy Associated With Other ConditionsUnited States
-
University of WashingtonNational Institute on Aging (NIA)Active, not recruitingLiver Cirrhosis | Quality of Life | Lung Neoplasms | Neoplasm Metastasis | Pulmonary Disease, Chronic Obstructive | Dementia | Kidney Failure, Chronic | Chronic Disease | Peripheral Vascular Disease | Lung Diseases, Interstitial | Health Communication | Heart Failure,Congestive | Patient Care | Health Care Quality... and other conditionsUnited States
-
University of WashingtonNational Institute on Aging (NIA)RecruitingPromoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers (PICSI-M)Liver Cirrhosis | Quality of Life | Neoplasm Metastasis | Pulmonary Disease, Chronic Obstructive | Peripheral Vascular Diseases | Dementia | Kidney Failure, Chronic | Chronic Disease | Lung Diseases, Interstitial | Health Communication | Lung Neoplasm | Heart Failure,Congestive | Patient Care | Health Care Quality... and other conditionsUnited States
-
University of WashingtonCompletedDiabetes Complications | Renal Insufficiency, Chronic | Dementia | Leukemia, Lymphocytic, Chronic, B-Cell | Peripheral Vascular Disease | Frail Elderly | Congestive Heart Failure | Malignant Neoplasm | Lung Disease Chronic | Liver Failures, ChronicUnited States
-
Hamilton Health Sciences CorporationMcMaster University; Edwards LifesciencesRecruitingAortic Valve Stenosis | Transcatheter Aortic Valve ReplacementCanada
-
University of ConnecticutNational Institute of Mental Health (NIMH)Completed
-
University of WashingtonRecruiting
-
United States Army Institute of Surgical ResearchCompleted
-
Maria Jesus PerezInstituto de Salud Carlos IIIUnknownCardiac Surgery