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Short Term Status of Free Dermal Fat Autografts 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.
Conditions:
🦠 Wound; Head, Multiple 🦠 Wound; Head, Scalp 🦠 Wound; Head 🦠 Wound Infection 🦠 Wound Complication 🦠 Wound Dehiscence 🦠 Wound of Skin 🦠 Wound Open 🦠 Wounds, Penetrating 🦠 Wounds, Nonpenetrating 🦠 Wounds and Injuries 🦠 Wounds 🦠 Disturbance of Wound Healing 🦠 Facial Bones Fracture 🦠 Soft Tissue Injuries 🦠 Skull Fractures 🦠 Surgical Wound 🦠 Surgical Wound Infection 🦠 Wound Healing
More conditions available...
🗓️ Study Start (Actual) 20 September 2023
🗓️ Primary Completion (Estimated) 20 September 2024
✅ Study Completion (Estimated) 11 November 2025
👥 Enrollment (Estimated) 20
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Fairfax, Virginia, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 9 March 2019
  • First Submitted that Met QC Criteria 12 March 2019
  • First Posted 13 March 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 June 2022
  • Last Update Posted 16 June 2022
  • Last Verified June 2022
I'm interested ...!!