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

NCT03880188 | Unknown

• 2 other identifiers: U1111-1219-3733000083
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Autologous Transplantation; Free Tissue Flaps; Graft Survival; Reconstructive Surgical Procedures; Patient Selection; Debridement; Subcutaneous Fat; Surgical Flaps; Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Histology and the presence of stem and immune cells in the free autologous dermal fat graft recipient site.

  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.

  Outcomes are evaluated at one clinical encounter, lasting approximately 1 hour.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dufresne, Craig, MD, PC: lead

Study Sites (1)

Office of Craig R Dufresne, MD, PC

Fairfax, Virginia, 22031, United States

Location

Related 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.

  PMID: 32310868 BACKGROUND

• 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.

  BACKGROUND

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Prepared and stained slides made from the material obtained during biopsies will be retained for use in the clinical care of the patient and research. Other material stored in formalin from biopsy specimens obtained will be banked for future use in immunohistochemistry studies to further define free DFA physiology. Additional IRB approval to use any the material from biopsy specimens for any future studies will be obtained. The specimens will not be shared with outside researchers.

MeSH Terms

Conditions

Wounds and Injuries; Wound Infection; Soft Tissue Injuries; Skull Fractures; Surgical Wound; Surgical Wound Infection; Wounds, Penetrating; Wounds, Nonpenetrating

Condition Hierarchy (Ancestors)

Infections; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Fractures, Bone; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Craig R Dufresne, MD

  Dr Craig R Dufresne, MD, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 19, 2019
• Study Start: September 10, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)