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Preoperative Jumpstart for Decolonization of P. Acnes

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ClinicalTrials.gov Identifier: NCT03466658
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
H Mike Kim, Milton S. Hershey Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Shoulder Arthropathy Associated With Other Conditions Device: JumpStart Antimicrobial Wound Dressing Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preoperative Application of Low-level Microcurrent Dressing (Jumpstart) for Decolonization of P. Acnes Before Shoulder Surgery
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Antibiotics

Arm Intervention/treatment
Experimental: JumpStart group
This group will have the JumpStart dressing pre-operatively. Intervention: JumpStart dressing
Device: 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.

No Intervention: Control group
This group will have no intervention pre-operatively. Intervention: none



Primary Outcome Measures :
  1. Presence of Propionibacterium acnes in skin biopsies during surgery [ Time Frame: 7 days post-biopsy ]
    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.



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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:

  • 18 years old or older
  • Scheduled to receive open or arthroscopic shoulder surgery

Exclusion Criteria:

  • 17 years old or younger
  • Pregnant women
  • Prisoners
  • Non-English speaking or unable to understand consent
  • History of any prior shoulder surgery
  • History of previous shoulder infection or clinical signs of preoperative infection
  • History of taking any antibiotic(s) within 4 weeks prior to the scheduled shoulder surgery
  • Active acne or skin inflammatory disorders (psoriasis, eczema, etc) in the shoulder

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): NCT03466658


Contacts
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Contact: Andrea Myers, RN, BSN 717-531-3892 amyers1@pennstatehealth.psu.edu
Contact: Julie Hong, BS 443-827-1361 jhong1@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State Bone and Joint Institute Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Hyunmin M Kim, MD       hkim2@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Hyunmin Kim, MD Penn State Bone and Joint Institute

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Responsible Party: H Mike Kim, MD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03466658     History of Changes
Other Study ID Numbers: 00009349
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 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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Joint Diseases
Musculoskeletal Diseases
Anti-Infective Agents
Anti-Bacterial Agents