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Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds (FTFDT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880188
Recruitment Status : Enrolling by invitation
First Posted : March 19, 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 2-30 years ago will have photographs and small biopsies taken of the area that was grafted.

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

Detailed Description:
Complex craniofacial wounds (CCW) are those considered to be refractory to initial reconstructive and antibiotic treatment and may involve chronic infection, exposed hardware, irradiated local tissue, and soft tissue volume loss. They are a functional, aesthetic, quality-of-life, and economic burden and have many aetiologies and impact patients of all ages from diverse socio-economic and geographical backgrounds. The present study will evaluate if free dermal fat autografts (DFA) can serve as a less involved, more dynamic approach than the standard of microvascular flaps to facilitate healing and reconstruction for CCW. A previous 33-year retrospective study of free DFA for CCW indicated recipient graft sites healed and remained volume-stable in most patients. To evaluate the long-term viability of this modality, clinical and histological assessments of free DFA recipient and undisturbed tissue at donor sites will be carried out in patients from the original cohort. In the present study, it will be first determined if free DFA continues to provide stable long-term outcomes for prevention of infection and hardware exposure and stable volume and contour results. Then, it will be determined if free DFA recipient sites retain normal, expected histology and immune cells (dermal lymphocytes, macrophages, and mast cells). Finally, it will be evaluated if the long-term free DFA recipient site tissues are significantly different from undisturbed tissue at donor sites with respect to the presence of adipose tissue and populations of immune cells. The present study will be the first to (1) evaluate the long-term fate of free DFA recipient sites in this complex craniofacial wounds, (2) determine the presence of immune cells within free DFA recipient sites, and (3) compare the long-term differences of free DFA recipient and undisturbed tissue at donor sites. Outcomes from this project will serve as the basis of understanding of free DFA survival and function in treating CCW and provide an investigative framework for more rigorous follow-up studies to define indications and refine techniques for free DFA use in this context and more generally.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Fat to the Future, Dermal Time 2: Long Term Clinical and Histological Status of Free Dermal Fat Autograft Recipient Sites: Cross-Sectional Assessment in a Retrospective Cohort Treated for Complex Craniofacial Wounds
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020





Primary Outcome Measures :
  1. Wound healing and defect amelioration. [ Time Frame: Outcomes are evaluated at one clinical encounter, lasting approximately 1 hour. ]
    Wound healing and defect amelioration will be clinically evaluated. Evaluation will be based on the absence of drainage, erythema, and oedema; reduction of pain; the presence of intact tissues and stable volume and contour in the area where the graft was placed.


Secondary Outcome Measures :
  1. Histology and the presence of stem and immune cells in the free autologous dermal fat graft recipient site. [ Time Frame: Outcomes are evaluated at one clinical encounter, lasting approximately 1 hour. ]
    Histology and the presence of stem and immune cells in the free autologous dermal fat graft recipient site will be qualitatively and quantitatively evaluated, according to standard laboratory procedures of the receiving institution, using the biopsies taken during the consultation and minor procedure visit.

  2. Histology and the presence of stem and immune cells in the native local tissue. [ Time Frame: Outcomes are evaluated at one clinical encounter, lasting approximately 1 hour. ]
    Histology and the presence of stem and immune cells in the native local tissue will be qualitatively and quantitatively evaluated, according to standard laboratory procedures of the receiving institution, using the biopsies taken during the consultation and minor procedure visit.


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.


Information from the National Library of Medicine

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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 drawn from a retrospective cohort of consecutive patients who underwent free autologous dermal fat grafting for one or more complex craniofacial wounds between 1985 and 2018, carried out by a single sub-speciality trained plastic surgeon (Study Principal Investigator).
Criteria

Inclusion Criteria:

  • Underwent free autologous dermal fat grafting carried out by the Study Principal Investigator for one or more complex craniofacial wounds
  • Speaks, reads, and understands English
  • Willing to freely give consent
  • Is able or has a legal representative to give consent

Exclusion Criteria:

  • Did not have free autologous dermal fat grafting
  • Did not undergo free autologous dermal fat grafting carried out by the Study Principal Investigator
  • Underwent free autologous dermal fat grafting carried out by the Study Principal Investigator for an indication other than for one or more complex craniofacial wounds
  • Lacks sufficient chart data for study requirements
  • Patients for whom it cannot be determined when they underwent free vs injected autologous dermal fat grafting
  • 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): NCT03880188


Locations
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United States, Virginia
Office of Craig R Dufresne, MD, PC
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Dufresne, Craig, MD, PC
Investigators
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Principal Investigator: Craig R Dufresne, MD Dr Craig R Dufresne, MD, PC
Additional Information:
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Responsible Party: Dufresne, Craig, MD, PC
ClinicalTrials.gov Identifier: NCT03880188    
Other Study ID Numbers: U1111-1219-3733
000083 ( Other Identifier: FSRG #1 IRB )
First Posted: March 19, 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
Wounds and Injuries
Fractures, Bone
Surgical Wound
Soft Tissue Injuries
Wounds, Penetrating
Wounds, Nonpenetrating
Postoperative Complications
Pathologic Processes
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases