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

Wounds and Injuries Clinical Trial

— FTFDT3  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03872544
• Other study ID #: U1111-1229-8480
• Secondary ID: 000088
• Status: Not yet recruiting
• Start date: September 20, 2023
• Est. completion date: November 11, 2025

Study information

• Verified date: June 2022
• Source: Dufresne, Craig, MD, PC
• Contact: Mikaela I Poling, BA
• Phone: 304-460-9038
• Email: research[@]duplastics.com
• 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 11, 2025
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

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	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	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.
Secondary	Concentration of adipocytes, mast cells, macrophages, and dermal lymphocytes in the wound site		Evaluated through study completion, an average of 2 years.
Secondary	Ratio for tissue type in the wound site	Tissue types considered are adipose and fibrous.	Evaluated through study completion, an average of 2 years.
Secondary	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.

External Links

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