BridgeMD
New treatment option for Burns
Official title Microsurfaced Grafts in Deep Burn Wounds
ClinicalTrials.gov ID: NCT04589442
What this study is testing
What is Split thickness skin graft?
Split thickness skin graft is an investigational medicine, being studied as a potential treatment for burns.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. This study will be performed in 2 parts: Time to wound bed preparedness through 6 weeks (Part A) and wound site healing, graft take and long-term scar outcomes (Part B).
- 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 21 and older
You may be able to join if
- Signed informed consent by patient or Legally Authorized Representative (LAR)
- Subject with deep partial or full thickness burn injury due to flame burn, scald injury or contact burn
- Study burn site large enough to accommodate placement of control and microsurfaced cadaveric graft (minimum 4 cm2 each) at the same location OR 2...
- Total Body Surface Area burned (TBSA) total ≤30 %
- Admission within 72 hours of burn injury
You likely can't join if
- Burns involving the face
- Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
- Admission time greater than 72 hours after the injury
- Wounds noted to be infected at admission
- Is pregnant or plans to become pregnant
- Is nursing or actively lactating
See the full eligibility criteria
- Signed informed consent by patient or Legally Authorized Representative (LAR)
- Subject with deep partial or full thickness burn injury due to flame burn, scald injury or contact burn
- Study burn site large enough to accommodate placement of control and microsurfaced cadaveric graft (minimum 4 cm2 each) at the same location OR 2 study burn sites large enough to each accommodate control and...
- Total Body Surface Area burned (TBSA) total ≤30 %
- Admission within 72 hours of burn injury
- Non-infected wound as diagnosed by the attending physician upon admission
- Treated as an outpatient or in an observational setting
- 21 years of age or older
- Burns involving the face
- Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
- Admission time greater than 72 hours after the injury
- Wounds noted to be infected at admission
- Is pregnant or plans to become pregnant
- Is nursing or actively lactating
- Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study...
- Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's participation in the study protocol or record study materials
- Any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study
The study team makes the final eligibility decision.
Where it's taking place
- Augusta, Georgia, 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, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Augusta, Georgia, 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.