NCT03872544

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Dufresne, Craig, MD, PC · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Timeline

• Start date: 2023-09-20
• Primary completion: 2024-09-20
• Completion: 2025-11-11
• First posted: 2019-03-13
• Last updated: 2022-06-16

Locations

1 site across 1 country: United States