Trauma Clinical Trial
Official title:
Limb Salvage Through Tissue Engineering: A Novel Treatment Modality Using Dehydrated Human Amnion/Chorion Membrane
NCT number | NCT03521258 |
Other study ID # | 9167 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2016 |
Est. completion date | February 2019 |
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.
Status | Recruiting |
Enrollment | 53 |
Est. completion date | February 2019 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United States | Louisiana State University Health Sciences Center - N.O. | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Louisiana State University Health Sciences Center in New Orleans |
United States,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Wound Issue | Were any of the following recorded: wound dehiscence, partial flap loss, or partial skin graft loss requiring prolonged local wound care or other wound treatment (e.g. hyperbaric oxygen therapy, negative pressure wound dressing, other wound devices)? | within 6 months of initial wound closure | |
Secondary | Epidermolysis | Was there any diagnosis of epidermolysis during study | within 6 months of initial wound closure | |
Secondary | Length of ICU stay | Total number of ICU inpatient days | within 6 months of initial wound closure | |
Secondary | Length of inpatient hospital stay | Total number of inpatient hospital days | within 6 months of initial wound closure | |
Secondary | Total treatment time from initial treatment to initial closure (excludes treatment of complications) | Total number of days from initial treatment to end of study | within 6 months of initial wound closure | |
Secondary | Total treatment time from initial treatment to completion of limb salvage (includes treatment of complications) | Total number of days from initial treatment to completion of limb salvage | within 6 months of initial wound closure | |
Secondary | Number of dHACM treatments required | Total number of EpiFix applications | within 6 months of initial wound closure | |
Secondary | Death from any cause | Death from any cause | within 6 months of initial wound closure | |
Secondary | Deep vein thrombosis diagnosed by radiologic imaging (e.g. ultrasound or CT) | Any diagnosis of DVT during study | within 6 months of initial wound closure | |
Secondary | Pulmonary embolus | Any diagnosis of PE during study | within 6 months of initial wound closure | |
Secondary | Ventilator-associated pneumonia | Any diagnosis of vent-associated pneumonia | within 6 months of initial wound closure | |
Secondary | Number of microsurgical revisions needed (arterial or venous) | Number of microsurgical revisions needed | within 6 months of initial wound closure | |
Secondary | Bony non union, bony melanin | Any diagnosis of bony non-union or bony melanin during study | within 6 months of initial wound closure | |
Secondary | Tendon rupture | Any diagnosis of tendon rupture during study | within 6 months of initial wound closure |
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