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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-20

Study Completion Date

2025-11-11

Brief Summary

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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.

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Detailed Description

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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

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No