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

NCT03521258 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-05-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Dehydrated Human Amnion/Chorion Membrane

PROCEDURE

Flap-Based Reconstructive Surgery

Standard of Care surgical intervention

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

    lead OTHER

Principal Investigators

  • Frank Lau, MD · Louisiana State University Health Sciences Center - New Orleans

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03521258 on ClinicalTrials.gov