Status:
UNKNOWN
Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Lead Sponsor:
Dufresne, Craig, MD, PC
Conditions:
Wound; Head, Multiple
Wound; Head, Scalp
Eligibility:
All Genders
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 under...
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. Currentl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 11 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03872544
Start Date
September 20 2023
End Date
November 11 2025
Last Update
June 16 2022
Active Locations (1)
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1
Office of Craig R Dufresne, MD, PC
Fairfax, Virginia, United States, 22031