Preoperative Jumpstart for Decolonization of P. Acnes
Primary Purpose
Shoulder Arthropathy Associated With Other Conditions
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
JumpStart Antimicrobial Wound Dressing
Sponsored by
About this trial
This is an interventional prevention trial for Shoulder Arthropathy Associated With Other Conditions
Eligibility 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
Sites / Locations
- Penn State Bone and Joint Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
JumpStart group
Control group
Arm Description
This group will have the JumpStart dressing pre-operatively. Intervention: JumpStart dressing
This group will have no intervention pre-operatively. Intervention: none
Outcomes
Primary Outcome Measures
Presence of Propionibacterium Acnes in Skin Biopsies During Surgery
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03466658
First Posted
March 9, 2018
Last Updated
January 2, 2020
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03466658
Brief Title
Preoperative Jumpstart for Decolonization of P. Acnes
Official Title
Preoperative Application of Low-level Microcurrent Dressing (Jumpstart) for Decolonization of P. Acnes Before Shoulder Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Unexpected culture contamination potentially due to a testing error
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthropathy Associated With Other Conditions
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JumpStart group
Arm Type
Experimental
Arm Description
This group will have the JumpStart dressing pre-operatively. Intervention: JumpStart dressing
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will have no intervention pre-operatively. Intervention: none
Intervention Type
Device
Intervention Name(s)
JumpStart Antimicrobial Wound Dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of Propionibacterium Acnes in Skin Biopsies During Surgery
Description
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.
Time Frame
7 days post-biopsy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyunmin Kim, MD
Organizational Affiliation
Penn State Bone and Joint Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Bone and Joint Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preoperative Jumpstart for Decolonization of P. Acnes
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