Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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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

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in drainage, erythema, oedema, and pain; and the presence of intact tissues associated with the wound | Visually appraised evidence of drainage, erythema, oedema, and pain; and the presence of intact tissues associated with the wound | Evaluated through study completion, an average of 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in volume and contour of the defect associated with the wound | Visually appraised volume and contour of the defect associated with the wound | Evaluated through study completion, an average of 2 years. | 
| Concentration of adipocytes, mast cells, macrophages, and dermal lymphocytes in the wound site |  | Evaluated through study completion, an average of 2 years. | 
| Ratio for tissue type in the wound site | Tissue types considered are adipose and fibrous. | Evaluated through study completion, an average of 2 years. | 
| Ratio of immune cell populations in the wound site | Immune cell types considered are mast cells, macrophages, and dermal lymphocytes. | Evaluated through study completion, an average of 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous Transplantation, Free Tissue Flaps, Graft Survival, Reconstructive Surgical Procedures, Patient Selection, Debridement, Subcutaneous Fat, Surgical Flaps, Treatment Outcome