Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds

NCT03872544 | Unknown

• 2 other identifiers: U1111-1229-8480000088
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Autologous Transplantation; Free Tissue Flaps; Graft Survival; Reconstructive Surgical Procedures; Patient Selection; Debridement; Subcutaneous Fat; Surgical Flaps; Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in volume and contour of the defect associated with the wound

  Evaluated through study completion, an average of 2 years.

• Concentration of adipocytes, mast cells, macrophages, and dermal lymphocytes in the wound site

  Evaluated through study completion, an average of 2 years.

• Ratio for tissue type in the wound site

  Evaluated through study completion, an average of 2 years.

• Ratio of immune cell populations in the wound site

  Evaluated through study completion, an average of 2 years.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dufresne, Craig, MD, PC: lead

Study Sites (1)

Office of Craig R Dufresne, MD, PC

Fairfax, Virginia, 22031, United States

Location

Related Publications (2)

• 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.

  PMID: 32310868 BACKGROUND

• 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.

  BACKGROUND

Related Links

• Principal Investigator's (Dr Craig R Dufresne) Research and Press Relations main webpage. Last Accessed: 7 Jun 2022

Biospecimen

Retention: SAMPLES WITHOUT DNA

Prepared and stained slides made from the material obtained during biopsies will be retained for use in the clinical care of the patient and research. Other material stored in formalin from biopsy specimens obtained will be banked for future use in immunohistochemistry studies to further define free DFA physiology. Additional IRB approval to use any the material from biopsy specimens for any future studies will be obtained. The specimens will not be shared with outside researchers.

MeSH Terms

Conditions

Wounds and Injuries; Wound Infection; Wounds, Penetrating; Wounds, Nonpenetrating; Soft Tissue Injuries; Skull Fractures; Surgical Wound; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Infections; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Fractures, Bone; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Craig R Dufresne, MD

  Dr Craig R Dufresne, MD, PC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikaela I Poling, BA

CONTACT

304-460-9038; research@duplastics.com

Craig R Dufresne, MD

CONTACT

703-207-3065; info@duplastics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 13, 2019
• Study Start: September 20, 2023
• Primary Completion: September 20, 2024
• Study Completion: November 11, 2025
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)