Clinical trial NCT04753723: The Use of a Platform Wound Device for Reducing Infection
Official title: The Use of a Platform Wound Device for Reducing Infection in Torso and Extremity Wounds: An Interventional Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wounds and Injury
Burn Wound
Infection Wound
Lead sponsor: The Metis Foundation
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of treatment
timeFrame: 48 to 96 hours
measure: Tolerability of treatment
timeFrame: 48 to 96 hours
Secondary outcomes:
measure: Effectiveness of wound swabs
timeFrame: 48 to 96 hours
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Baptist Medical Center
state: Texas
city: San Antonio
country: United States
facility: North East Baptist Hospital
state: Texas
city: San Antonio
country: United States
facility: Mission Trail Baptist Hospital
state: Texas
city: San Antonio
country: United States
facility: North Central Baptist Hospital
state: Texas
Study officials:
References: