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Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds (FTFDT3)

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ClinicalTrials.gov Identifier: NCT03872544
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Estimated Study Start Date : September 20, 2019
Estimated Primary Completion Date : September 20, 2024
Estimated Study Completion Date : November 11, 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in drainage, erythema, oedema, and pain; and the presence of intact tissues associated with the wound [ Time Frame: 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 :
  1. Change in volume and contour of the defect associated with the wound [ Time Frame: Evaluated through study completion, an average of 2 years. ]
    Visually appraised volume and contour of the defect associated with the wound

  2. Concentration of adipocytes, mast cells, macrophages, and dermal lymphocytes in the wound site [ Time Frame: Evaluated through study completion, an average of 2 years. ]
  3. Ratio for tissue type in the wound site [ Time Frame: Evaluated through study completion, an average of 2 years. ]
    Tissue types considered are adipose and fibrous.

  4. Ratio of immune cell populations in the wound site [ Time Frame: Evaluated through study completion, an average of 2 years. ]
    Immune cell types considered are mast cells, macrophages, and dermal lymphocytes.


Biospecimen Retention:   Samples Without DNA
Prepared and stained slides made from the material obtained during biopsies will be retained for use in the clinical care of the patient and research. Other material stored in formalin from biopsy specimens obtained will be banked for future use in immunohistochemistry studies to further define free DFA physiology. Additional IRB approval to use any the material from biopsy specimens for any future studies will be obtained. The specimens will not be shared with outside researchers.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential patients are any consecutive patients not part of a retrospective cohort who undergo free autologous dermal fat grafting for one or more complex craniofacial wounds, carried out by a single sub-speciality trained plastic surgeon (Study Principal Investigator).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872544


Contacts
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Contact: Craig R Dufresne, MD 7032073065 luikart2@icloud.com
Contact: Mikaela I Poling, BA 3044609038 poling_mi@fsrgroup.org

Locations
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United States, Virginia
Office of Craig R Dufresne, MD, PC Not yet recruiting
Fairfax, Virginia, United States, 22031
Contact: Office of Craig R Dufresne, MD, PC    703-207-3065    info@cdufresne.com   
Contact: Mikaela I Poling, BA    304-460-9038    poling_mi@fsrgroup.org   
Principal Investigator: Craig R Dufresne, MD         
Sub-Investigator: Mikaela I Poling, BA         
Sponsors and Collaborators
Dufresne, Craig, MD, PC
Investigators
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Principal Investigator: Craig R Dufresne, MD Craig R Dufresne, MD, PC

Additional Information:
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Responsible Party: Dufresne, Craig, MD, PC
ClinicalTrials.gov Identifier: NCT03872544     History of Changes
Other Study ID Numbers: U1111-1229-8480
000088 ( Other Identifier: FSRG #1 IRB )
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data (IPD) or biospecimens will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dufresne, Craig, MD, PC:
Autologous Transplantation
Free Tissue Flaps
Graft Survival
Reconstructive Surgical Procedures
Patient Selection
Debridement
Subcutaneous Fat
Surgical Flaps
Treatment Outcome
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Skull Fractures
Fractures, Bone
Surgical Wound
Soft Tissue Injuries
Wounds, Penetrating
Wounds, Nonpenetrating
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases