Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT03466658
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.
Study:
NCT03466658
Study Brief:
Protocol Section:
NCT03466658