The Use of a Platform Wound Device for Reducing Infection

• Sponsor: The Metis Foundation (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04753723
• Collaborator: (none)
• Enrollment: 50
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 11
• Patients Per Site: 12.5
• Patients Per Site Per Month: 1.1

Study Details

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
• Anticipated 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
• Anticipated Study Start Date: Feb 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Jan 1, 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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Baptist Medical Center	San Antonio	Texas	United States	78205
2	North East Baptist Hospital	San Antonio	Texas	United States	78217
3	Mission Trail Baptist Hospital	San Antonio	Texas	United States	78235
4	North Central Baptist Hospital	San Antonio	Texas	United States	78258

Sponsors and Collaborators

• The Metis Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Study Results

No Results Posted as of Feb 15, 2021