Recruiting

Dehydrated Human Amnion/Chorion Membrane

Sponsor:

Louisiana State University Health Sciences Center in New Orleans

Code:

NCT03521258

Conditions

Wounds

Trauma

Injury

Limb Salvage

Soft Tissue Injuries

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Dehydrated Human Amnion/Chorion Membrane

Flap-Based Reconstructive Surgery

Study Details

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

Study ID

NCT03521258

Start date

Feb, 2016

Status verified date

Apr, 2018

Completion date

Feb, 2019

Anticipated

Primary completion date

Feb, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Study Design

Enrollment

53 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Human Amnion/Chorion Membrane + skin graft

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.

active comparator: Flap Reconstruction (Standard of Care)

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.

Interventions

Dehydrated Human Amnion/Chorion Membrane

Flap-Based Reconstructive Surgery

Standard of Care surgical intervention

Primary outcome measure

  • Treatment failure [ Time Frame: Within 6 weeks of treatment ]

Central Contacts and Locations

Central contacts

Frank Lau, MD

504-412-1240flau@lsuhsc.edu

Locations

Louisiana State University Health Sciences Center - N.O.

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Frank Lau, MD

504-412-1240flau@lsuhsc.edu

More Information

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Last update posted

May 11, 2018

Last verified

Apr, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louisiana State University Health Sciences Center in New Orleans on 2018-05-11.