Limb Salvage Through Tissue Engineering: A Novel Treatment Modality Using Dehydrated Human Amnion/Chorion Membrane

Status unconfirmed · Not applicable

Conditions studied: Wounds, Trauma, Injury, Limb Salvage, Soft Tissue Injuries

In brief

Extremity wounds with exposed critical structures, including bone and tendon are a major burden on the American healthcare system with limited treatment options. Free Flap reconstructions of lower extremity wounds have an increased failure rate in comparison to elective free flap procedures.These procedures are long and are associated with a high cost of care, prolonged hospital stays, and are limited by the need for surgical specialist availability and patient vessels suitable for anastomoses. This study will use a new treatment modality which is a commercially ready human amniotic membrane allograft (EpiFix) to promote a granulation tissue wound base that will be suitable for skin grafting, thus forgoing the need for a flap-based for reconstruction. The study goals are to reduce the overall cost of providing definitive treatment by decreasing operative time, length of hospital stay, decrease the need for intensive nursing care and rehabilitation. This study will aim to provide a treatment option that is readily accessible to all patients with these complex wounds in any healthcare setting across the country.

Key facts

Study ID

NCT03521258

Run by

Louisiana State University Health Sciences Center in New Orleans

People needed

53

Starts

2016-02-01

Expected to finish

2019-02-01

Last updated by the study team

2018-05-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Wound includes exposed critical structures (tendon and/or bone)
• Patient is candidate flap reconstruction
• Patient is candidate for limb salvage

You may not qualify if…

• Wound involves weight-bearing surfaces (e.g. heel or forefoot wounds),
• Exposed implanted hardware (e.g. surgical plates)
• Anticipated need for future surgical procedures through the same wound
• Wounds resulting from surgical removal of malignancy
• Patients who are not flap candidates (e.g. severe peripheral vascular disease)
• Patients who are not limb salvage candidates (e.g. insensate or ischemic limbs).

Where it is running

• Louisiana State University Health Sciences Center - N.O. — New Orleans, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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