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

Wounds and Injuries Clinical Trial

— FTFDT2  

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03880188
• Other study ID #: U1111-1219-3733
• Secondary ID: 000083
• Status: Enrolling by invitation
• Start date: September 10, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2022
• Source: Dufresne, Craig, MD, PC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 2-30 years ago will have photographs and small biopsies taken of the area that was grafted.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Disturbance of Wound Healing
• Facial Bones Fracture
• Fractures, Bone
• Infections
• Skull Fractures
• Soft Tissue Injuries
• Surgical Wound
• Surgical Wound Infection
• Wound Complication
• Wound Dehiscence
• Wound Healing
• Wound Infection
• Wound of Skin
• Wound Open
• Wound; Head
• Wound; Head, Multiple
• Wound; Head, Scalp
• Wounds
• Wounds and Injuries
• Wounds, Nonpenetrating
• Wounds, Penetrating

Locations

Country	Name	City	State
United States	Office of Craig R Dufresne, MD, PC	Fairfax	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Dufresne, Craig, MD, PC

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

Outcome

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.

External Links

•   Principal Investigator's (Dr Craig R Dufresne) Research and Press Relations main webpage. Last Accessed: 7 Jun 2022