Efficacy and Safety of a Nanofat-seeded Biological Scaffold in Healing Lower Limb Surgical Defects
Withdrawn before enrolling · Not applicable
Conditions studied: Wound of Skin, Non-melanoma Skin Cancer, Skin Graft Complications, Wound of Lower Leg, Wound of Knee
In brief
Large full-thickness skin defects, such as those resulting from trauma, large and giant congenital nevi, disfiguring scars, or tumor resection remain major clinical problems to patients and physicians. Skin flaps and grafts represent the current standard of care (SOC), but often present limitations associated with surgical morbidity and donor site availability. The investigators will enroll 64 patients who have their skin cancer surgically removed and require reconstructive procedure such as a skin flap/graft. To objective of this study is to assess the efficacy and safety of a nanofat-seeded biological scaffold versus the SOC in healing larger surgical defects (\>1.5cm) involving the lower limb that cannot be closed by direct suture and thus need a reconstructive procedure such as a skin flap/graft.
Key facts
- Study ID
- NCT03548610
- Run by
- Brigham and Women's Hospital
- People needed
- 0
- Starts
- 2019-01-30
- Expected to finish
- 2021-07-31
- Last updated by the study team
- 2020-02-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- Age less than 18 years of age
- Pregnant women
- Any contraindications to use of nanofat or collagen scaffold
Where it is running
- Mohs and Dermatologic Surgery Center, Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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