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New treatment option for Facial Defect
Official title Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting
ClinicalTrials.gov ID: NCT06747715
What this study is testing
- What it's testing
- The goal of this clinical trial is to validate the safety and effectiveness of a two-stage approach for minimally invasive craniofacial soft tissue reconstruction using autologous fat grafting in wounded service members and veterans. The main questions it aims to answer are: 1.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged 18 years or older and able to provide informed consent,
- Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 3 and 150 cc of lipoaspirate (the...
- Be at least 3 months post-injury or most recent surgery, so that acute edema (swelling) is resolved.
- Volume defects (facial injury) are covered by intact skin and do not communicate with oral cavity or sinuses.
- The three-dimensional geometry of the volume defects (facial injury) would allow for treatment with fat grafting.
You likely can't join if
- Age less than 18 years.
- Inability to provide informed consent.
- Craniofacial defects intended for treatment have open wounds or communicate with oral cavity or sinus (note: A second facial injury, that will not be...
- Active infection anywhere in the body.
- Systemic disease or medical condition that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the...
- History of radiation to the areas intended for treatment or the graft harvest site
See the full eligibility criteria
- Aged 18 years or older and able to provide informed consent,
- Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 3 and 150 cc of lipoaspirate (the patient's own fat, collected through liposuction). This may include...
- Be at least 3 months post-injury or most recent surgery, so that acute edema (swelling) is resolved.
- Volume defects (facial injury) are covered by intact skin and do not communicate with oral cavity or sinuses.
- The three-dimensional geometry of the volume defects (facial injury) would allow for treatment with fat grafting.
- Has sufficient donor tissue, as assessed on physical exam, to graft deformity and cryostore an equal amount of adipose (fat) tissue.
- Willing and able to comply with follow up examinations, including radiographic studies (i.e. CT scans)
- Age less than 18 years.
- Inability to provide informed consent.
- Craniofacial defects intended for treatment have open wounds or communicate with oral cavity or sinus (note: A second facial injury, that will not be treated by the study, that includes this type of defect, will not...
- Active infection anywhere in the body.
- Systemic disease or medical condition that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
- History of radiation to the areas intended for treatment or the graft harvest site
- Medications that would significantly impact wound healing, such as immunosuppressive agents, chronic steroid treatment, or chemotherapy, or medications/allergies that would pose a risk to anesthesia or the planned...
- Active narcotic abuse (presents a variable for pain logs).
- Known coagulopathy (increased risk of bleeding/delay in forming blood clots).
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, 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.