Free Dermal Fat Autografts in Craniofacial Wounds
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/17/2019 |
| Start Date: | September 20, 2019 |
| End Date: | November 11, 2025 |
| Contact: | Craig R Dufresne, MD |
| Email: | luikart2@icloud.com |
| Phone: | 7032073065 |
Fat to the Future, Dermal Time 3: Prospective, Single-Blind, Randomised Controlled Trial of Free Dermal Fat Autografting for Treatment of Complex Craniofacial Wounds
This study will evaluate the use of free autologous dermal fat grafting to treat complex
craniofacial wounds that have failed standard treatment and to understand how these grafts
help the wounds heal. Half of the patients in this study will be randomly chosen to have free
autologous dermal fat grafting (in addition to any other care required, such as antibiotics
or surgery to clean the wound) to treat their complex craniofacial wounds. The other half of
patients will receive standard care only, such as antibiotics or surgery to clean the wound,
to treat their complex craniofacial wound.
craniofacial wounds that have failed standard treatment and to understand how these grafts
help the wounds heal. Half of the patients in this study will be randomly chosen to have free
autologous dermal fat grafting (in addition to any other care required, such as antibiotics
or surgery to clean the wound) to treat their complex craniofacial wounds. The other half of
patients will receive standard care only, such as antibiotics or surgery to clean the wound,
to treat their complex craniofacial wound.
A complex craniofacial wound is a wound on the head or face that will not heal, despite
efforts to heal the wound with standard treatments, such as antibiotics and surgery to clean
the wound. Currently, there are no good treatment options for these types of complex
craniofacial wounds. This study will evaluate what happens when free autologous dermal fat
grafting is used to help treat complex craniofacial wounds by evaluating the area where the
graft was placed to better understand how these types of grafts function. Free autologous
dermal fat grafting is the process of taking fat from under the outer layer of skin and
moving it to another part of the body of the same individual. Although free autologous dermal
fat grafts have been used for many decades in plastic and reconstructive surgery to help a
variety of patients suffering from different problems, only one study has used them to help
heal complex craniofacial wounds. This use of free autologous dermal fat grafting is not
considered to be experimental or an investigational product by the US Food and Drug
Administration (FDA). Still, the use of free autologous dermal fat grafting has not been
formally evaluated to understand how these types of grafts help patients with complex
craniofacial wounds.
efforts to heal the wound with standard treatments, such as antibiotics and surgery to clean
the wound. Currently, there are no good treatment options for these types of complex
craniofacial wounds. This study will evaluate what happens when free autologous dermal fat
grafting is used to help treat complex craniofacial wounds by evaluating the area where the
graft was placed to better understand how these types of grafts function. Free autologous
dermal fat grafting is the process of taking fat from under the outer layer of skin and
moving it to another part of the body of the same individual. Although free autologous dermal
fat grafts have been used for many decades in plastic and reconstructive surgery to help a
variety of patients suffering from different problems, only one study has used them to help
heal complex craniofacial wounds. This use of free autologous dermal fat grafting is not
considered to be experimental or an investigational product by the US Food and Drug
Administration (FDA). Still, the use of free autologous dermal fat grafting has not been
formally evaluated to understand how these types of grafts help patients with complex
craniofacial wounds.
Inclusion Criteria:
- Presence of a complex craniofacial wound, defined by failure of initial reconstructive
and antibiotic treatment and the presence of chronic infection, exposed hardware,
irradiated local tissue, or soft tissue volume loss
- Presence of wound contracture, breakdown of overlying tissue, or challenging
anatomical deformities
- Patient has had two or more failed reconstructive attempts or has failed two or more
attempts to treat local infection
- Speak, read, and understand English
- Willing to freely give consent
- Is able or has a legal representative to give consent
Exclusion Criteria:
- Absence of a complex craniofacial wound, defined by failure of initial reconstructive
and antibiotic treatment and the presence of chronic infection, exposed hardware,
irradiated local tissue, or soft tissue volume loss
- Absence of wound contracture, breakdown of overlying tissue, or challenging aesthetic
deformities
- Patient has not had two or more failed reconstructive attempts or has not failed two
or more attempts to treat local infection
- Does not speak, read, or understand English
- Unwilling to freely give consent
- Is unable or does not have a legal representative to give consent
We found this trial at
1
site
Fairfax, Virginia 22031
Principal Investigator: Craig R Dufresne, MD
Phone: 703-207-3065
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