The Use of a Platform Wound Device for Reducing Infection

NCT ID: NCT04753723

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2022-05-25

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.

Conditions

Wounds and Injury; Burn Wound; Infection Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Platform wound device with antibiotic

Antibiotic cream will be applied to study wounds and then dressed with the platform wound device.

Group Type: EXPERIMENTAL

Gentamycin with Platform Wound Device

Intervention Type: COMBINATION_PRODUCT

Treatment of wounds with gentamycin and covered with platform wound device.

Standard of Care

Study wounds will be treated per the standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gentamycin with Platform Wound Device

Treatment of wounds with gentamycin and covered with platform wound device.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Metis Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

PWD-1

Identifier Type: -

Identifier Source: org_study_id