The Use of a Platform Wound Device for Reducing Infection

The Use of a Platform Wound Device for Reducing Infection in Torso and Extremity Wounds: An Interventional Clinical Trial

This study will evaluate the safety and efficacy of a novel Platform Wound Device (PWD) in its delivery of a local antibiotic, 0.1% Gentamycin cream, to prevent or treat infection in torso and extremity wounds. The hypothesis is that the PWD will be a safe and effective method to provide topical antibiotics to a torso or extremity wound, non-inferior to the current standard of care. This treatment will reduce or rapidly eradicate infection.

Study Overview

• Status: Completed
• Conditions: Burn Wound; Wounds and Injury; Infection Wound
• Intervention / Treatment: Combination product: Gentamycin with Platform Wound Device

Detailed Description

This is a prospective, randomized, controlled clinical trial comparing the use of a platform wound device as compared to standard of care to prevent or eliminate infection in torso and extremity wounds. Patients 18-85 years of age admitted for treatment of open wound(s) will be screened for inclusion criteria and asked to consent to participate in the randomized study. The first 10 patients will be treated with the PWD + gentamicin and will serve as a safety subset. Baseline measurement of serum antibiotic concentraion will be taken prior to PWD placement and one day after. Following the safety subset, 50 patients will be randomized to standard of care or to a single application of the PWD + gentamicin. Baseline assessments will be completed on day 0, including screening, pre-procedure wound evaluation, imaging, assessments, and specimen collection. Follow-up assessments will be completed and data gathered at days 1,2,3 and 4. All data collected of the study participants will be used to evaluate the PWD delivery of antibiotic.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78258
      • North Central Baptist Hospital
    • San Antonio, Texas, United States, 78205
      • Baptist Medical Center
    • San Antonio, Texas, United States, 78217
      • North East Baptist Hospital
    • San Antonio, Texas, United States, 78235
      • Mission Trail Baptist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age greater or equal to 18 and age less than or equal to 85
2. Open wound up to 500cm2 in area with evidence of infection
3. Exposure of deep dermis, subcutaneous tissue, muscle, fascia, tendon, or bone

Exclusion Criteria:

1. Pregnancy
2. Prisoner
3. Active malignancy, steroid use, or immunosuppressive therapy
4. Open fracture intimately involved with wound
5. Underlying osteomyelitis
6. Hardware or prosthetic exposure within wound
7. Exposure of major named vessels or nerves
8. Known allergy to gentamicin or other aminoglycosides

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platform wound device with antibiotic; Antibiotic cream will be applied to study wounds and then dressed with the platform wound device.	Combination product: Gentamycin with Platform Wound Device; Treatment of wounds with gentamycin and covered with platform wound device.
No Intervention: Standard of Care; Study wounds will be treated per the standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of treatment	Demonstration of the ability to enroll patients at a single institution to either the control group, receiving standard of care, or the treatment group, receiving PWD delivery and 1 dose of antibiotic (0.1% gentamicin cream) over 48 to 96 hours.	48 to 96 hours
Tolerability of treatment	To demonstrate that patients are able to tolerate application of the PWD with 0.1% gentamicin cream application. Tolerability will be assessed by documentation of adverse events.	48 to 96 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of wound swabs	To demonstrate that wound swabs are an accurate and reliable measurement of infection based on semi-quantitative wound culture results.	48 to 96 hours

Collaborators and Investigators

• Sponsor: The Metis Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): November 19, 2021
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: PWD-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes