Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds (FTFDT3)

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

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.

Study Overview

• Status: Not yet recruiting
• 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

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.

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

Contacts and Locations

• Study Contact: Name: Craig R Dufresne, MD; Phone Number: 703-207-3065; Email: info@duplastics.com
• Study Contact Backup: Name: Mikaela I Poling, BA; Phone Number: 304-460-9038; Email: research@duplastics.com

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 any consecutive patients not part of a retrospective cohort who undergo free autologous dermal fat grafting for one or more complex craniofacial wounds, carried out by a single sub-speciality trained plastic surgeon (Study Principal Investigator).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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.

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 20, 2023
• Primary Completion (Anticipated): September 20, 2024
• Study Completion (Anticipated): November 11, 2025

Study Registration Dates

• First Submitted: March 9, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 13, 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: U1111-1229-8480; 000088 (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