The Use of a Platform Wound Device for Reducing Infection

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.

Inclusion criteria

• 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

Exclusion criteria

• 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