Autologous Fat Grafting for Immediate Soft-Tissue Reconstruction After Injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares immediate autologous adipose tissue grafting combined with a layered composite reconstruction to the standard split-thickness skin graft approach for acute soft-tissue damage. Blinded evaluators will assess healing, scar formation, and infection risk in adults with full-thickness injuries requiring reconstruction. Participants receive fat grafting at the wound site along with skin grafting in a single procedure. The goal is to determine if the fat-based layer provides a softer, more vascular reconstruction that supports a single-stage operation with potentially better functional outcomes. Study sites include two Pittsburgh-area hospitals, led by the University of Pittsburgh with collaboration from AFIRM.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The proposed study will include adult patients 18 years of age or older,
* male or female,
* civilian, military, active duty or retired veterans
* presenting for unilateral or bilateral fasciotomy of the extremity at any level necessary
* secondary to non-infectious etiology,
* unilateral or bilateral traumatic full-thickness skin loss of the face, head, neck or extremities necessitating reconstruction, and/or
* full or partial thickness burn injury of the face, neck, or extremity requiring excision and/or reconstruction.
* Additional inclusion criteria includes willingness to be randomized to receive a fat graft.

Exclusion Criteria:

* Age \< 18 years of age,
* active infection,
* medical co-morbidities or anatomic configuration deemed by the physician to be a concern for safety,
* unwilling or unable to comply with study procedures,
* radiation to the site of interest,
* prisoners and/or vulnerable populations.
* In addition, candidates that are pregnant or plan to become pregnant in the next year, will be excluded.

Where it's running

• Mercy Hospital
  Pittsburgh, Pennsylvania, United States Recruiting
• Presbyterian Hospital
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Francesco Egro — University of Pittsburgh
• Study coordinator: Eleanor Shirley
• Email: shirleye@upmc.edu
• Phone: 412-641-8676

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Autologous layered fat-and-skin grafting for post-burn scar contracture

  This study tests whether using a patient’s own fat layer plus a skin graft can match the results of a full-thickness skin graft for delayed reconstruction of burn- or trauma-related scar contractures.

  Recruiting at 2 sites University of Pittsburgh · Pittsburgh, Pennsylvania and 1 other locations · NCT06857435

• Early detection of sepsis-related blood clotting problems in severe burn patients

  This study tests how well the JAAM-2 score can detect sepsis-induced coagulopathy early in adults with severe burns who develop sepsis in the ICU.

  Recruiting Center for Traumatology and Major Burns, Ben Arous · Tunis · NCT07914205

• THERAVEX Tissue Care Spray Plus for Healing of Skin Wounds and Ulcers

  This observational review tests whether THERAVEX Tissue Care Spray Plus, used with standard wound care, helps heal various skin wounds and chronic ulcers in adults.

  Recruiting Biointelligent Technology Systems SL · Barcelona · NCT07617961

• Efferon LPS hemoadsorption for severe burns

  This study tests whether adding Efferon LPS hemoadsorption to standard care can help burn patients with high illness scores see if their symptoms improve and prevent organ failure.

  Recruiting Efferon JSC · Moscow · NCT07568132

• Wearable hip-robot training to improve walking after major lower-leg burns

  This 12-week program will try using a wearable hip-assist robot during daily physiotherapy to help adults who still have walking problems six months after large lower-extremity burns walk better.

  Recruiting Hangang Sacred Heart Hospital · Seoul · NCT07277166

• Tilapia skin versus regular dressings for second- and third-degree burns

  This trial will test whether tilapia fish skin dressings help people with second- or third-degree burns heal better than regular dressings.

  Recruiting Sohag University · Sohag · NCT07142824

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.