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Compares treatment options for Wounds and Injuries
Official title Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing
ClinicalTrials.gov ID: NCT05424354
What this study is testing
- What it's testing
- This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 72 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
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 65. Healthy volunteers may be eligible.
You may be able to join if
- Hospitalized patients who are receiving burn care; patients may be discharged when clinically stable and continue with outpatient treatment.
- Men and women (women cannot be pregnant or breast feeding) ages 18-65 years old
- Wounds must be partial thickness, involving up to 20% of the total body surface area.
- Burn injury should be less than 72 hours old
- Willing and able to comply with protocol mandated scheduled study visits/clinical evaluations.
You likely can't join if
- Known allergy to TPD or its components
- Women who are pregnant, breast feeding, or plan to get pregnant during the study period.
- Infected wounds
- Presence of any full thickness (third degree) burns
- Electrical burns
- Heavily draining burns due to underlying chronic lymphedema or other conditions
See the full eligibility criteria
- Hospitalized patients who are receiving burn care; patients may be discharged when clinically stable and continue with outpatient treatment.
- Men and women (women cannot be pregnant or breast feeding) ages 18-65 years old
- Wounds must be partial thickness, involving up to 20% of the total body surface area.
- Burn injury should be less than 72 hours old
- Willing and able to comply with protocol mandated scheduled study visits/clinical evaluations.
- Willing and able to provide written informed consent.
- Known allergy to TPD or its components
- Women who are pregnant, breast feeding, or plan to get pregnant during the study period.
- Infected wounds
- Presence of any full thickness (third degree) burns
- Electrical burns
- Heavily draining burns due to underlying chronic lymphedema or other conditions
- Concurrent clinical condition within the judgement of the clinician, pose a health risk to the patient, delay wound healing, or otherwise influence the outcome of the study.
- History of poor wound healing and/or skin/immune system condition
- Deemed by clinician not to be suitable
- Unwilling or not able to provide consent or comply with protocol or required visits
- Developmental disability/significant psychological disorder which can impair the people ability to provide informed consent, or participate in the study protocol
- Active alcohol or substance abuse
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Louisville, Kentucky, United States
- Valhalla, New York, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Louisville, Kentucky, United States; Valhalla, New York, United States; Dallas, 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.