The Use of a Platform Wound Device for Reducing Infection

Burn Wound Clinical Trial

Official title:

The Use of a Platform Wound Device for Reducing Infection in Torso and Extremity Wounds: An Interventional Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753723
• Other study ID #: PWD-1
• Status: Completed
• Phase: Phase 4
• Start date: February 8, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: October 2022
• Source: The Metis Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 25, 2022
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Wound
• Communicable Diseases
• Infection Wound
• Infections
• Wounds and Injuries
• Wounds and Injury

Intervention

Combination Product:
• Gentamycin with Platform Wound Device
Treatment of wounds with gentamycin and covered with platform wound device.

Locations

Country	Name	City	State
United States	Baptist Medical Center	San Antonio	Texas
United States	Mission Trail Baptist Hospital	San Antonio	Texas
United States	North Central Baptist Hospital	San Antonio	Texas
United States	North East Baptist Hospital	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Metis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of treatment	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.	48 to 96 hours
Primary	Tolerability of treatment	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.	48 to 96 hours
Secondary	Effectiveness of wound swabs	To demonstrate that wound swabs are an accurate and reliable measurement of infection based on semi-quantitative wound culture results.	48 to 96 hours