Wound; Head, MultipleFTFDT3NCT03872544
Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
An observational study of Wound; Head, Multiple and Wound; Head, Scalp, run by Dufresne, Craig, MD, PC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound; Head, Multiple, Wound; Head, Scalp, Wound; Head
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 11 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Office of Craig R Dufresne, MD, PC
Fairfax, Virginia, 22031
About this study
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
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.
Read the 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
- Keywords
- Autologous Transplantation, Free Tissue Flaps, Graft Survival, Reconstructive Surgical Procedures, Patient Selection, Debridement, Subcutaneous Fat, Surgical Flaps, Treatment Outcome
- Medical subject headings
- Wounds and Injuries, Wound Infection, Wounds, Penetrating, Wounds, Nonpenetrating, Soft Tissue Injuries, Skull Fractures, Surgical Wound, Surgical Wound Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in drainage, erythema, oedema, and pain; and the presence of intact tissues associated with the wound
Visually appraised evidence of drainage, erythema, oedema, and pain; and the presence of intact tissues associated with the wound
Measured: Evaluated through study completion, an average of 2 years.
Secondary outcomes (4)
Change in volume and contour of the defect associated with the wound
Visually appraised volume and contour of the defect associated with the wound
Measured: Evaluated through study completion, an average of 2 years.
Concentration of adipocytes, mast cells, macrophages, and dermal lymphocytes in the wound site
Measured: Evaluated through study completion, an average of 2 years.
Ratio for tissue type in the wound site
Tissue types considered are adipose and fibrous.
Measured: Evaluated through study completion, an average of 2 years.
Ratio of immune cell populations in the wound site
Immune cell types considered are mast cells, macrophages, and dermal lymphocytes.
Measured: Evaluated through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start20 Sep 2023 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion11 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wound; Head, MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dufresne, Craig, MD, PC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig R Dufresne, MD, Principal investigator, Dr Craig R Dufresne, MD, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872544
- Sponsor's protocol ID
- U1111-1229-8480
- Other IDs
- 000088
- Acronym
- FTFDT3
- Status last verified
- Jun 2022
- First submitted
- 9 Mar 2019
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) or biospecimens will be shared.
Publications
Dufresne CR, Poling MI. Free Dermal Fat Autografting for Complex Craniofacial Wounds. J Craniofac Surg. 2020 Sep;31(6):1563-1567. doi: 10.1097/SCS.0000000000006398.
PubMed 32310868Dufresne CR, Poling MI. Free Dermal Fat Autografts for Complex Craniofacial Wounds: A 3-decade, Retrospective Cohort Study. PRS Global Open. 2019 August; 7(8S-1):101. doi: 10.1097/01.GOX.0000584800.01063.18.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03872544
- Acronym / sponsor ID
- FTFDT3 / U1111-1229-8480
- Conditions
- Wound; Head, Multiple, Wound; Head, Scalp, Wound; Head, Wound Infection, Wound Complication, Wound Dehiscence
- Keywords
- Autologous Transplantation, Free Tissue Flaps, Graft Survival, Reconstructive Surgical Procedures, Patient Selection, Debridement, Subcutaneous Fat, Surgical Flaps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dufresne, Craig, MD, PCUniversity, hospital or other
- Study start
- 20 Sep 2023 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 11 Nov 2025 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Change in volume and contour of the defect associated with the wound
Time frame: Evaluated through study completion, an average of 2 years.
Concentration of adipocytes, mast cells, macrophages, and dermal lymphocytes in the wound site
Time frame: Evaluated through study completion, an average of 2 years.
Ratio for tissue type in the wound site
Time frame: Evaluated through study completion, an average of 2 years.
Ratio of immune cell populations in the wound site
Time frame: Evaluated through study completion, an average of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Background: PubMed 32310868Dufresne CR, Poling MI. Free Dermal Fat Autografting for Complex Craniofacial Wounds. J Craniofac Surg. 2020 Sep;31(6):1563-1567. doi: 10.1097/SCS.0000000000006398.
- BackgroundDufresne CR, Poling MI. Free Dermal Fat Autografts for Complex Craniofacial Wounds: A 3-decade, Retrospective Cohort Study. PRS Global Open. 2019 August; 7(8S-1):101. doi: 10.1097/01.GOX.0000584800.01063.18.
- Principal Investigator's (Dr Craig R Dufresne) Research and Press Relations main webpage. Last Accessed: 7 Jun 2022Link provided by the sponsor.
- Individual participant dataSharing planned: No. No individual participant data (IPD) or biospecimens will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig R Dufresne, MD principal investigator
Dr Craig R Dufresne, MD, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound; Head, Multiple and Wound; Head, Scalp, run by Dufresne, Craig, MD, PC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikaela I Poling, BA (304-460-9038, research@duplastics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872544, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.