Long-Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds



Status:Enrolling by invitation
Conditions:Infectious Disease, Hospital, Hospital, Orthopedic
Therapuetic Areas:Immunology / Infectious Diseases, Orthopedics / Podiatry, Other
Healthy:No
Age Range:Any
Updated:3/22/2019
Start Date:September 10, 2018
End Date:June 30, 2020

Use our guide to learn which trials are right for you!

Fat to the Future, Dermal Time 2: Long-Term Clinical and Histological Status of Free Autologous Dermal Fat Graft Recipient Site: Cross-Sectional Assessment in a Retrospective Cohort Treated for 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 well these
grafts work to repair wounds long term. Patients who have undergone free autologous dermal
fat grafting to treat complex craniofacial wounds 2-30 years ago will have photographs and
small biopsies taken of the area that was grafted.

Complex craniofacial wounds (CCW) are those considered to be refractory to initial
reconstructive and antibiotic treatment and may involve chronic infection, exposed hardware,
irradiated local tissue, and soft tissue volume loss. They are a functional, aesthetic,
quality-of-life, and economic burden and have many aetiologies and impact patients of all
ages from diverse socio-economic and geographical backgrounds. The present study will
evaluate if free dermal fat autografts (DFA) can serve as a less involved, more dynamic
approach than the standard of microvascular flaps to facilitate healing and reconstruction
for CCW. A previous 33-year retrospective study of free DFA for CCW indicated recipient graft
sites healed and remained volume-stable in most patients. To evaluate the long-term viability
of this modality, clinical and histological assessments of free DFA recipient and undisturbed
tissue at donor sites will be carried out in patients from the original cohort. In the
present study, it will be first determined if free DFA continues to provide stable long-term
outcomes for prevention of infection and hardware exposure and stable volume and contour
results. Then, it will be determined if free DFA recipient sites retain normal, expected
histology and immune cells (dermal lymphocytes, macrophages, and mast cells). Finally, it
will be evaluated if the long-term free DFA recipient site tissues are significantly
different from undisturbed tissue at donor sites with respect to the presence of adipose
tissue and populations of immune cells. The present study will be the first to (1) evaluate
the long-term fate of free DFA recipient sites in this complex craniofacial wounds, (2)
determine the presence of immune cells within free DFA recipient sites, and (3) compare the
long-term differences of free DFA recipient and undisturbed tissue at donor sites. Outcomes
from this project will serve as the basis of understanding of free DFA survival and function
in treating CCW and provide an investigative framework for more rigorous follow-up studies to
define indications and refine techniques for free DFA use in this context and more generally.

Inclusion Criteria:

- Underwent free autologous dermal fat grafting carried out by the Study Principal
Investigator for one or more complex craniofacial wounds

- Speaks, reads, and understands English

- Willing to freely give consent

- Is able or has a legal representative to give consent

Exclusion Criteria:

- Did not have free autologous dermal fat grafting

- Did not undergo free autologous dermal fat grafting carried out by the Study Principal
Investigator

- Underwent free autologous dermal fat grafting carried out by the Study Principal
Investigator for an indication other than for one or more complex craniofacial wounds

- Lacks sufficient chart data for study requirements

- Patients for whom it cannot be determined when they underwent free vs injected
autologous dermal fat grafting

- 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
?
mi
from
Fairfax, VA
Click here to add this to my saved trials