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Efficacy and Safety of a Nanofat-seeded Biological Scaffold in Healing Lower Limb Surgical Defects

NCT03548610 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-02-11

No results posted yet for this study

Summary

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.

Conditions

  • Wound of Skin
  • Non-melanoma Skin Cancer
  • Skin Graft Complications
  • Wound of Lower Leg
  • Wound of Knee

Interventions

OTHER

Nanofat-seeded biological scaffold on surgical defect

Nanofat-seeded biological scaffold in healing larger surgical defects (\>1.5cm) involving the lower limbs

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Chrysalyne D Schmults, MD, MSCE · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2021-03-31
Completion
2021-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03548610 on ClinicalTrials.gov