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

Status unconfirmed

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

In brief

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.

Key facts

Study ID

NCT03872544

Run by

Dufresne, Craig, MD, PC

People needed

20

Starts

2023-09-20

Expected to finish

2025-11-11

Last updated by the study team

2022-06-16

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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