The Use of a Platform Wound Device for Reducing Infection

• ClinicalTrials.gov Identifier: NCT04753723
• Recruitment Status: Not yet recruiting
• First Posted: February 15, 2021
• Last Update Posted: February 15, 2021
• Sponsor: The Metis Foundation
• Information provided by (Responsible Party): The Metis Foundation

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Wounds and Injury; Burn Wound; Infection Wound	Combination Product: Gentamycin with Platform Wound Device	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Use of a Platform Wound Device for Reducing Infection in Torso and Extremity Wounds: An Interventional Clinical Trial
• Estimated Study Start Date: February 2021
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: January 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of treatment [ Time Frame: 48 to 96 hours ]
   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.
2. Tolerability of treatment [ Time Frame: 48 to 96 hours ]
   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.

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Victoria Hatem; 2105691140; hatem@metisfoundationusa.org

Locations

United States, Texas

Baptist Medical Center

San Antonio, Texas, United States, 78205

Contact: Victoria Hatem

Principal Investigator: Rodney Chan, MD

North East Baptist Hospital

San Antonio, Texas, United States, 78217

Contact: Victoria Hatem

Principal Investigator: Rodney Chan, MD

Mission Trail Baptist Hospital

San Antonio, Texas, United States, 78235

Contact: Victoria Hatem

Principal Investigator: Rodney Chan, MD

North Central Baptist Hospital

San Antonio, Texas, United States, 78258

Contact: Victoria Hatem

Principal Investigator: Rodney Chan, MD

Sponsors and Collaborators

The Metis Foundation

More Information

• Responsible Party: The Metis Foundation
• ClinicalTrials.gov Identifier: NCT04753723
• Other Study ID Numbers: PWD-1
• First Posted: February 15, 2021
• Last Update Posted: February 15, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Infections; Communicable Diseases; Wounds and Injuries; Disease Attributes; Pathologic Processes; Gentamicins; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action