Wounds and Injuries Clinical Trial
— FTFDT2Official title:
Fat to the Future, Dermal Time 2: Long Term Clinical and Histological Status of Free Dermal Fat Autograft Recipient Sites: Cross-Sectional Assessment in a Retrospective Cohort Treated for Complex Craniofacial Wounds
Verified date | June 2022 |
Source | Dufresne, Craig, MD, PC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 2-30 years ago will have photographs and small biopsies taken of the area that was grafted.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Office of Craig R Dufresne, MD, PC | Fairfax | Virginia |
Lead Sponsor | Collaborator |
---|---|
Dufresne, Craig, MD, PC |
United States,
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. — View 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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound healing and defect amelioration. | Wound healing and defect amelioration will be clinically evaluated. Evaluation will be based on the absence of drainage, erythema, and oedema; reduction of pain; the presence of intact tissues and stable volume and contour in the area where the graft was placed. | Outcomes are evaluated at one clinical encounter, lasting approximately 1 hour. | |
Secondary | Histology and the presence of stem and immune cells in the free autologous dermal fat graft recipient site. | Histology and the presence of stem and immune cells in the free autologous dermal fat graft recipient site will be qualitatively and quantitatively evaluated, according to standard laboratory procedures of the receiving institution, using the biopsies taken during the consultation and minor procedure visit. | Outcomes are evaluated at one clinical encounter, lasting approximately 1 hour. | |
Secondary | Histology and the presence of stem and immune cells in the native local tissue. | Histology and the presence of stem and immune cells in the native local tissue will be qualitatively and quantitatively evaluated, according to standard laboratory procedures of the receiving institution, using the biopsies taken during the consultation and minor procedure visit. | Outcomes are evaluated at one clinical encounter, lasting approximately 1 hour. |
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