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
NCT number | NCT04753723 |
Other study ID # | PWD-1 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | February 8, 2021 |
Est. completion date | May 25, 2022 |
Verified date | October 2022 |
Source | The Metis Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
The Metis Foundation |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03948360 -
Safety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
|
N/A | |
Completed |
NCT04277182 -
Effect of Propolis Application on Burn Healing
|
N/A | |
Enrolling by invitation |
NCT00978705 -
Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
|
Phase 3 | |
Withdrawn |
NCT03675568 -
Non-cultured Autologous Keratinocyte Suspension Versus Traditional Split Skin Graft for Burn Wounds Treatment
|
N/A | |
Active, not recruiting |
NCT04828304 -
PLASOMA Ultimate Safety & Efficacy Study
|
N/A | |
Not yet recruiting |
NCT05649332 -
Study to Evaluate the Performance and Safety of the Medical Device Argogen
|
N/A | |
Recruiting |
NCT05593523 -
Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes
|
||
Completed |
NCT06280053 -
HealiAid in the Treatment of Different Wounds
|
N/A | |
Enrolling by invitation |
NCT06103409 -
MSCs for the Treatment of Burn Wounds
|
Phase 1/Phase 2 | |
Recruiting |
NCT05796492 -
Ultrasound Treatment on Wound Healing Time
|
N/A | |
Enrolling by invitation |
NCT04725071 -
Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults
|
N/A | |
Suspended |
NCT02577120 -
Wound Healing Endpoint and Recurrence
|
Phase 4 | |
Active, not recruiting |
NCT05341427 -
DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING
|
N/A | |
Terminated |
NCT03723590 -
A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG
|
N/A | |
Not yet recruiting |
NCT04011306 -
A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
|
N/A | |
Recruiting |
NCT05404191 -
Prediction Rules for Low Level Laser on Burn Wounds
|
N/A | |
Completed |
NCT02982096 -
Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique
|
N/A |