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

Not yet recruiting

• Conditions: Wound Dehiscence; Disturbance of Wound Healing; Wounds and Injuries; Skull Fractures; Surgical Wound; Wound; Head, Multiple; Wound Infection; Wounds; Surgical Wound Infection; Wound; Head

• Registration Number: NCT03872544
• Lead Sponsor: Dufresne, Craig, MD, PC

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 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.

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 Timeline

• Study First Submitted: 2019-03-09
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-13
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-16
• Study Start: 2023-09-20
• Primary Completion: 2024-09-20
• Study Completion: 2025-11-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in drainage, erythema, oedema, and pain; and the presence of intact tissues associated with the wound	Evaluated through study completion, an average of 2 years.	Visually appraised evidence of drainage, erythema, oedema, and pain; and the presence of intact tissues associated with the wound

Secondary Outcome Measures

Name	Time	Method
Change in volume and contour of the defect associated with the wound	Evaluated through study completion, an average of 2 years.	Visually appraised volume and contour of the defect associated with the wound
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	Evaluated through study completion, an average of 2 years.	Tissue types considered are adipose and fibrous.
Ratio of immune cell populations in the wound site	Evaluated through study completion, an average of 2 years.	Immune cell types considered are mast cells, macrophages, and dermal lymphocytes.

Trial Locations

Locations (1)

Office of Craig R Dufresne, MD, PC; 🇺🇸 Fairfax, Virginia, United States