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

June 14, 2022 updated by: Dufresne, Craig, MD, PC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Office of Craig R Dufresne, MD, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Outcomes are evaluated at one clinical encounter, lasting approximately 1 hour.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Outcomes are evaluated at one clinical encounter, lasting approximately 1 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dufresne, Craig, MD, PC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Craig R Dufresne, MD, Dr Craig R Dufresne, MD, PC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U1111-1219-3733
  • 000083 (Other Identifier: FSRG #1 IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data (IPD) or biospecimens will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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