UnknownNot Applicable

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

United States20 participantsStarted 2023-09-20

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in drainage, erythema, oedema, and pain; and the presence of intact tissues associated with the wound

Timeframe: Evaluated through study completion, an average of 2 years.

Trial details

NCT IDNCT03872544

SponsorDufresne, Craig, MD, PC

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-20

Contact for this trial

Mikaela I Poling, BA

304-460-9038 research@duplastics.com

View on ClinicalTrials.gov More Wound; Head, Multiple trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.