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
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Arthropathy Associated With Other Conditions||Device: JumpStart Antimicrobial Wound Dressing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|Contact: Andrea Myers, RN, BSNemail@example.com|
|Contact: Julie Hong, BSfirstname.lastname@example.org|
|United States, Pennsylvania|
|Penn State Bone and Joint Institute||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Hyunmin M Kim, MD email@example.com|
|Principal Investigator:||Hyunmin Kim, MD||Penn State Bone and Joint Institute|