Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms

  • Communicable Diseases
  • Disturbance of Wound Healing
  • Facial Bones Fracture
  • Fractures, Bone
  • Infections
  • Skull Fractures
  • Soft Tissue Injuries
  • Surgical Wound
  • Surgical Wound Infection
  • Wound Complication
  • Wound Dehiscence
  • Wound Healing
  • Wound Infection
  • Wound of Skin
  • Wound Open
  • Wound; Head
  • Wound; Head, Multiple
  • Wound; Head, Scalp
  • Wounds
  • Wounds and Injuries
  • Wounds, Nonpenetrating
  • Wounds, Penetrating

NCT number NCT03880188
Study type Observational
Source Dufresne, Craig, MD, PC
Contact
Status Enrolling by invitation
Phase
Start date September 10, 2022
Completion date June 30, 2024

See also
  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 NCT04438174 - Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds Phase 1/Phase 2
Completed NCT03463720 - Outcome for Patients With War-Associated Extremity Wound Infection N/A
Active, not recruiting 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
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
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
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