The Use of a Platform Wound Device for Reducing Infection

Completed · Phase 4

Conditions studied: Wounds and Injury, Burn Wound, Infection Wound

In brief

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.

Key facts

Study ID

NCT04753723

Run by

The Metis Foundation

People needed

48

Starts

2021-02-08

Expected to finish

2022-05-25

Last updated by the study team

2022-10-14

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Pregnancy
• Prisoner
• Active malignancy, steroid use, or immunosuppressive therapy
• Open fracture intimately involved with wound
• Underlying osteomyelitis
• Hardware or prosthetic exposure within wound
• Exposure of major named vessels or nerves
• Known allergy to gentamicin or other aminoglycosides

Where it is running

• Baptist Medical Center — San Antonio, Texas, United States
• North East Baptist Hospital — San Antonio, Texas, United States
• Mission Trail Baptist Hospital — San Antonio, Texas, United States
• North Central Baptist Hospital — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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