Preoperative Jumpstart for Decolonization of P. Acnes

NCT03466658 | Terminated Results FDA Device

• 1 other identifier: 00009349
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthropathy Associated With Other Conditions

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days post-biopsy

Study Arms (2)

JumpStart group

EXPERIMENTAL

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

Device: JumpStart Antimicrobial Wound Dressing

Control group

NO INTERVENTION

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

Interventions

JumpStart Antimicrobial Wound Dressing 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.

JumpStart group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Bone and Joint Institute

Hershey, Pennsylvania, 17033, United States

Location

Results Point of Contact

• Title: Dr. Hyunmin Kim
• Organization: Penn State Health

hkim2@pennstatehealth.psu.edu

717-531-4826

Study Officials

• Hyunmin Kim, MD

  Penn State Bone and Joint Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 15, 2018
• Study Start: November 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 6, 2020
• Results First Posted: January 6, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)