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

NCT03521258 | Unknown

• 1 other identifier: 9167
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Wounds; Trauma; Injury; Limb Salvage; Soft Tissue Injuries

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  "Failure" will be defined as a composite of amputation, persistent exposed critical structures, development of osteomyelitis or need for additional flaps within 6 weeks of treatment. * Osteomyelitis will be diagnosed as pus from bone requiring long-term (\>4 weeks) of IV antibiotics.), * Experimental Group: "Persistent exposed critical structures" in the experimental arm refers to persistence of exposed nerve, blood vessels, bone or tendon after 4 weeks of dHACM treatment * Standard of care group: Persistence of exposed nerve, blood vessels, bone or tendon after flap treatment

  Within 6 weeks of treatment

Secondary Outcomes (14)

• Wound Issue

  within 6 months of initial wound closure

• Epidermolysis

  within 6 months of initial wound closure

• Length of ICU stay

  within 6 months of initial wound closure

• Length of inpatient hospital stay

  within 6 months of initial wound closure

• Total treatment time from initial treatment to initial closure (excludes treatment of complications)

  within 6 months of initial wound closure

Study Arms (2)

Human Amnion/Chorion Membrane + skin graft

EXPERIMENTAL

Dehydrated Human Amnion/Chorion Membrane (dHACM) will be placed on wound at the initial debridement to promote granulation tissue at the wound bed. Approximately 5-7 days following debridement, wound will be assessed for suitability of split thickness skin grafting. If an adequate granulation tissue is present, skin grafting will be performed and assessed for take in 5 days.

Device: Dehydrated Human Amnion/Chorion Membrane

Flap Reconstruction (Standard of Care)

ACTIVE COMPARATOR

A negative pressure wound dressing (NPWD) will be applied at the time of debridement until the wound is clean and adequate for flap reconstruction. Flap-based reconstruction is performed. Following flap reconstruction,patient will have 5 days of bed rest to allow proper healing and coverage of the wounds. If flaps are successful, patients starts a limb dangle protocol which gradually increases the dependent position and allows the flap to acclimate to new physiologic demands. Following dangle protocol patient will require inpatient physical and occupational therapy prior to discharge.

Procedure: Flap-Based Reconstructive Surgery

Interventions

Dehydrated Human Amnion/Chorion Membrane DEVICE

Also known as: human amniotic membrane allograft, EpiFix

Human Amnion/Chorion Membrane + skin graft

Flap-Based Reconstructive Surgery PROCEDURE

Standard of Care surgical intervention

Flap Reconstruction (Standard of Care)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

Louisiana State University Health Sciences Center - N.O.

New Orleans, Louisiana, 70115, United States

RECRUITING

Related Publications (21)

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• Lau FH, Hoffman RD, Danos D, Torabi R, Patterson CW, McKendrick AD, Stalder M, Dupin C, Hilaire HS. Regenerative vs flap-based limb salvage: a multi-centered, prospective, randomized controlled trial. Regen Med. 2023 Mar;18(3):207-218. doi: 10.2217/rme-2022-0147. Epub 2023 Feb 16.

  PMID: 36794542 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Soft Tissue Injuries

Study Officials

• Frank Lau, MD

  Louisiana State University Health Sciences Center - New Orleans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank Lau, MD

CONTACT

504-412-1240; flau@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Surgery

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: May 11, 2018
• Study Start: February 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: May 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)