Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds (FTFDT2)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Wounds and Injuries; Soft Tissue Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection; Wounds, Nonpenetrating; Skull Fractures; Wound Healing; Wounds; Wounds, Penetrating; Wound Complication; Wound of Skin; Wound Open; Wound Dehiscence; Facial Bones Fracture; Disturbance of Wound Healing; Wound; Head, Multiple; Wound; Head, Scalp; Wound; Head

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Office of Craig R Dufresne, MD, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential patients are drawn from a retrospective cohort of consecutive patients who underwent free autologous dermal fat grafting for one or more complex craniofacial wounds between 1985 and 2018, carried out by a single sub-speciality trained plastic surgeon (Study Principal Investigator).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Dufresne, Craig, MD, PC
• Investigators: Principal Investigator: Craig R Dufresne, MD, Dr Craig R Dufresne, MD, PC

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Anticipated): September 10, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Treatment Outcome; Debridement; Graft Survival; Autologous Transplantation; Subcutaneous Fat; Patient Selection; Reconstructive Surgical Procedures; Free Tissue Flaps; Surgical Flaps
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Disease Attributes; Craniocerebral Trauma; Trauma, Nervous System; Infections; Communicable Diseases; Wounds and Injuries; Soft Tissue Injuries; Fractures, Bone; Surgical Wound; Surgical Wound Infection; Wound Infection; Wounds, Penetrating; Wounds, Nonpenetrating; Skull Fractures
• Other Study ID Numbers: U1111-1219-3733; 000083 (Other Identifier: FSRG #1 IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data (IPD) or biospecimens will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No