Wounds and Injuries Clinical Trial
— FTFDT3Official 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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | November 11, 2025 |
Est. primary completion date | September 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Office of Craig R Dufresne, MD, PC | Fairfax | Virginia |
Lead Sponsor | Collaborator |
---|---|
Dufresne, Craig, MD, PC |
United States,
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. — View Citation
Dufresne 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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Evaluated through study completion, an average of 2 years. | |
Secondary | Change in volume and contour of the defect associated with the wound | Visually appraised volume and contour of the defect associated with the wound | Evaluated through study completion, an average of 2 years. | |
Secondary | Concentration of adipocytes, mast cells, macrophages, and dermal lymphocytes in the wound site | Evaluated through study completion, an average of 2 years. | ||
Secondary | Ratio for tissue type in the wound site | Tissue types considered are adipose and fibrous. | Evaluated through study completion, an average of 2 years. | |
Secondary | Ratio of immune cell populations in the wound site | Immune cell types considered are mast cells, macrophages, and dermal lymphocytes. | Evaluated through study completion, an average of 2 years. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04554212 -
Blood Flow Restriction Training After Patellar INStability
|
N/A | |
Suspended |
NCT02932176 -
Machine Learning for Handheld Vascular Studies
|
||
Recruiting |
NCT04803253 -
Study of the Social and Professional Reintegration Improvements Using a Set of Solutions for Upper Limb Amputation
|
N/A | |
Completed |
NCT00116337 -
Spinal Cord Stimulation to Restore Cough
|
N/A | |
Completed |
NCT03463720 -
Outcome for Patients With War-Associated Extremity Wound Infection
|
N/A | |
Completed |
NCT03113253 -
TRANexamic Acid to Reduce Bleeding in BURN Surgery
|
Phase 4 | |
Not yet recruiting |
NCT05492903 -
COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP)
|
N/A | |
Terminated |
NCT02909231 -
One-year Patient Reported Outcomes Following Hospitalization for Trauma
|
N/A | |
Completed |
NCT02432456 -
Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients
|
Phase 4 | |
Completed |
NCT02744144 -
Wound Bacterial Microbiota and Their Antibiotic Resistance
|
N/A | |
Completed |
NCT02266771 -
Impact of V.A.C. Veraflo Therapy in Wounds Requiring Debridement Within an Orthopedic Practice
|
N/A | |
Completed |
NCT02394821 -
Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide
|
Phase 3 | |
Not yet recruiting |
NCT01665963 -
Efficacy of TopClosure(C)System in Healing Complicated Pacemaker Wounds
|
N/A | |
Completed |
NCT00151112 -
Comparison of Two Different Procedures for Plexus Anesthesia
|
N/A | |
Recruiting |
NCT04596124 -
Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze
|
N/A | |
Recruiting |
NCT05800834 -
Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds
|
Phase 2 | |
Enrolling by invitation |
NCT03880188 -
Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Terminated |
NCT04775316 -
Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
|
||
Enrolling by invitation |
NCT03312504 -
Implementing a School Prevention Program to Reduce Injuries Through Neuromuscular Training
|
N/A | |
Terminated |
NCT03688880 -
A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced
|
N/A |