Status:
COMPLETED
The Use of a Platform Wound Device for Reducing Infection
Lead Sponsor:
The Metis Foundation
Conditions:
Wounds and Injury
Burn Wound
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 extremi...
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 wound...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04753723
Start Date
February 8 2021
End Date
May 25 2022
Last Update
October 14 2022
Active Locations (4)
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1
Baptist Medical Center
San Antonio, Texas, United States, 78205
2
North East Baptist Hospital
San Antonio, Texas, United States, 78217
3
Mission Trail Baptist Hospital
San Antonio, Texas, United States, 78235
4
North Central Baptist Hospital
San Antonio, Texas, United States, 78258