Clinical trial NCT03872544: Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Official title: Fat to the Future, Dermal Time 3: Short and Medium Term Clinical and Histological Status of Free Dermal Fat Autograft Recipient Sites: Observational Study of a Prospective Cohort Treated for Complex Craniofacial Wounds
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Wound; Head, Multiple
Wound; Head, Scalp
Wound; Head
Wound Infection
Wound Complication
Wound Dehiscence
Wound of Skin
Wound Open
Wounds, Penetrating
Wounds, Nonpenetrating
Wounds and Injuries
Wounds
Disturbance of Wound Healing
Facial Bones Fracture
Soft Tissue Injuries
Skull Fractures
Surgical Wound
Surgical Wound Infection
Wound Healing
Keywords: Autologous Transplantation
Free Tissue Flaps
Graft Survival
Reconstructive Surgical Procedures
Patient Selection
Debridement
Subcutaneous Fat
Surgical Flaps
Treatment Outcome
Lead sponsor: Dufresne, Craig, MD, PC
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential patients are any consecutive patients not part of a retrospective cohort who undergo free autologous dermal fat grafting for one or more complex craniofacial wounds, carried out by a single sub-speciality trained plastic surgeon (Study Principal Investigator).

Brief summary: This study will evaluate the use of free autologous dermal fat grafting (also called free dermal fat autografting) 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 less than 1 week ago will have photographs and small biopsies taken of the area that was grafted. Patients will be followed for 2 years to monitor the area that was grafted.

Detailed description: 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 dermal fat autografting 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 dermal fat autografting 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 dermal fat autografts 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 dermal fat autografting is not considered to be experimental or an investigational product by the US Food and Drug Administration (FDA). Still, the use of free dermal fat autografting has not been formally evaluated to understand how these types of grafts help patients with complex craniofacial wounds.

Eligibility criteria: 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

Primary outcomes:
measure: Change in drainage, erythema, oedema, and pain; and the presence of intact tissues associated with the wound
timeFrame: Evaluated through study completion, an average of 2 years.
Secondary outcomes:
measure: Change in volume and contour of the defect associated with the wound
timeFrame: Evaluated through study completion, an average of 2 years.
measure: Concentration of adipocytes, mast cells, macrophages, and dermal lymphocytes in the wound site
timeFrame: Evaluated through study completion, an average of 2 years.
measure: Ratio for tissue type in the wound site
timeFrame: Evaluated through study completion, an average of 2 years.
measure: Ratio of immune cell populations in the wound site
timeFrame: Evaluated through study completion, an average of 2 years.
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Office of Craig R Dufresne, MD, PC
state: Virginia
Study officials:
affiliation: Dr Craig R Dufresne, MD, PC
name: Craig R Dufresne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dufresne CR, Poling MI. Free Dermal Fat Autografting for Complex Craniofacial Wounds. J Craniofac Surg. 2020 Sep;31(6):1563-1567. doi: 10.1097/SCS.0000000000006398.
citation: Dufresne CR, Poling MI. Free Dermal Fat Autografts for Complex Craniofacial Wounds: A 3-decade, Retrospective Cohort Study. PRS Global Open. 2019 August; 7(8S-1):101. doi: 10.1097/01.GOX.0000584800.01063.18.