Efficacy and Safety of a Nanofat-seeded Biological Scaffold in Healing Lower Limb Surgical Defects
Wound of Skin, Non-melanoma Skin Cancer, Skin Graft Complications
About this trial
This is an interventional treatment trial for Wound of Skin focused on measuring nanofat, tumor defect
Eligibility Criteria
Inclusion Criteria:
- Subjects who need to undergo a surgical intervention resulting in complex lower limb surgical defects that cannot be closed primarily, and thus need a reconstructive phase
- Willing to undertake all study procedures, including nanofat harvesting from stomach site
- Willing to sign an informed consent form
Exclusion Criteria:
- Age less than 18 years of age
- Pregnant women
- Any contraindications to use of nanofat or collagen scaffold
Sites / Locations
- Mohs and Dermatologic Surgery Center, Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Nanofat-seeded biological scaffold on surgical defect
Standard of Care dressings
Nanofat is obtained via lipoaspiration of 10cc of fat from abdomen under moderate local tumescent anesthesia w/ saline. Cannula access point is anesthetized by local lidocaine infiltration. Lipoaspirate is processed into nanofat using the Tonnard method, after 3-minute decantation. Aspiration is performed using a multihole 3mm cannula. Wound margin + bed is treated w/ topical & local injections of nanofat, then covered w/ a biological scaffold, the inferior surface of which is soaked in nanofat; scaffold is fixed w/ external dressings or resorbable sutures; external covering includes polyurethane film & 3 layers of dressings. Topical application creates a fine <1mm nanofat layer. Scaffold (Puracol Plus) is left in place to integrate w/ surrounding skin, while external dressings changed at 7 & 15 days. Lipoaspirate donor site needs mild to moderate compression for 24 hours & suture removal (if not absorbed) at 7 days.
Immediately after surgical resection, each patient will be treated following the SOC, therefore with a local skin flap, rather than with a skin graft, based on surgeon assessment. Sutures, and moulage, if present, will be removed at 7 days and patient instructed to apply a daily silicone cream and sunscreen for 2 months.