跳至主要内容
临床试验/NCT03466658
NCT03466658终止不适用

Preoperative Application of Low-level Microcurrent Dressing (Jumpstart) for Decolonization of P. Acnes Before Shoulder Surgery

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
17
试验地点
1
主要终点
Presence of Propionibacterium Acnes in Skin Biopsies During Surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

JumpStart group

Experimental

This group will have the JumpStart dressing pre-operatively. Intervention: JumpStart dressing

干预措施: JumpStart Antimicrobial Wound Dressing (Device)

Control group

No Intervention

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

结局指标

主要结局

Presence of Propionibacterium Acnes in Skin Biopsies During Surgery

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

H Mike Kim

MD

Milton S. Hershey Medical Center

研究点 (1)

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