BridgeMD
New treatment option for Burn Wounds - Partial Thickness (2nd Degree)
Official title Field Shield Wound Dressing Study
ClinicalTrials.gov ID: NCT07337616
What this study is testing
- What it's testing
- This study is to compare the Field Shield Wound Dressing (FSWD) as a treatment for burn wounds to a standard of care burn wound dressing to evaluate healing, infection, pain/discomfort, and deepening of wound over time.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Thermal injury size 5-30% TBSA
- Admitted to the burn center and enroll able within 72 hours of injury
- Subject has two distinct areas of 100cm2 or larger of intermediate to deep partial thickness burns (study sites). These areas are judged to be...
- The subject and or caregiver is able and willing to follow the protocol requirements
- Achieve wound photos and dressing change at 3 days
You likely can't join if
- Subject has congestive heart failure, oxygen-dependent chronic lung disease, end-stage renal disease, or liver cirrhosis
- Subject is undergoing hospice care.
- Subject is currently being treated for an active malignant disease
- Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety
- Known contraindications to silver metals, silver chloride, or silver tetraoxide
- Known contraindications to lidocaine
See the full eligibility criteria
- Thermal injury size 5-30% TBSA
- Admitted to the burn center and enroll able within 72 hours of injury
- Subject has two distinct areas of 100cm2 or larger of intermediate to deep partial thickness burns (study sites). These areas are judged to be comparable in depth.
- The subject and or caregiver is able and willing to follow the protocol requirements
- Achieve wound photos and dressing change at 3 days
- Subject has congestive heart failure, oxygen-dependent chronic lung disease, end-stage renal disease, or liver cirrhosis
- Subject is undergoing hospice care.
- Subject is currently being treated for an active malignant disease
- Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety
- Known contraindications to silver metals, silver chloride, or silver tetraoxide
- Known contraindications to lidocaine
- Known allergies to any components of either primary dressing in the study
- Known allergies to the silicone or adhesives in secondary dressings
- Burns located on the hands, feet, face, and/or genitals will be excluded from treatment sites, but will be included in the total TBSA calculation
- Subject has a combined TBSA of 31% or greater of partial and/or full thickness burn wounds
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Subject is pregnant, breast feeding, or planning to become pregnant.
- people who, within 60 days prior to enrollment, have a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, application of...
- Burn study site(s) has been previously treated with tissue engineered materials (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis, Matristem) preceding the study wound dressing application.
- Burn study site(s) has been previously treated with a silvadene
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- San Antonio, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.