Preoperative Jumpstart for Decolonization of P. Acnes

NCT ID: NCT03466658

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-08-01

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.

Conditions

Shoulder Arthropathy Associated With Other Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

JumpStart group

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

Group Type: EXPERIMENTAL

JumpStart Antimicrobial Wound Dressing

Intervention Type: DEVICE

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

H Mike Kim

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyunmin Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State Bone and Joint Institute

Locations

Penn State Bone and Joint Institute

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

00009349

Identifier Type: -

Identifier Source: org_study_id