Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Spray Skin Applied Over Bilayered Wound Matrix

Stopped early · Not applicable

Conditions studied: Wounds and Injury

In brief

The purpose of this investigation is to evaluate the safety, tolerability, preliminary and long-term effectiveness of utilizing the ReCell Autologous Cell Harvesting Device (ReCell) combined with widened split-thickness skin graft (STSG) mesh onto the dermal regenerate INTEGRA™ Meshed Bilayer Wound Matrix (MBWM) for healing of full-thickness wounds.

Key facts

Study ID

NCT02469168

Run by

Rubin, J. Peter, MD

People needed

1

Starts

2014-12-01

Expected to finish

2017-12-01

Last updated by the study team

2018-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • The subject is a male or female military healthcare beneficiary of any race or ethnicity, aged 18 years or older, who is being treated for a traumatic wound at WRNMMC
• The subject has soft tissue loss resulting from a traumatic mechanism such as an explosive blast (i.e. motar, rocket, IED), high-velocity shells (i.e. missile), an avulsion injury, gunshot wound motor vehicle accident and/or burn secondary to blast
• The subject's full-thickness or deep partial-thickness traumatic wound injury has been treated with INTEGRA™ MBWM as part of their standard of care
• The wound area is at least 200 cm2
• All areas of the study wound area are covered with INTEGRA™ MBWM and has fully engrafted - engrafting defined as the presence of a contiguous vascularized granulation layer indicated by the formation of a viable granulation layer (Note: there may be some areas of incomplete granulation at the INTEGRA™ MBWM application site, these areas will be excluded from the study wound area).
• The subject will comply with protocol requirements
• The subject will provide voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

You may not qualify if…

• Subjects will not be eligible for study participation if they meet any of the following criteria:
• The subject is pregnant and/or lactating (self-reported)
• The subject has evidence of the following lab value results:
• Hematocrit ≤ 20%
• INR > 1.8 second
• Creatinine (serum) > 2.0 mg/dL
• Bilirubin Total (serum) within upper limit of normal (normal range 0.3-1.9 md/dL
• Liver function test (AST/ALT) greater than 2 times upper limit of normal as defined by the clinical laboratory defined normal ranges
• Albumin (serum) < 2.0 g/dL
• Platelets < 70 K/µL
• The subject's targeted traumatic wound injury is a craniofacial wound
• The subject's targeted traumatic wound injury is on a weight-bearing surface
• The subject's targeted traumatic wound is a full-thickness burn injury with visible eschar present (Note: Subjects with a traumatic wound of a burn nature secondary to an explosive blast injury resulting in significant soft tissue loss will NOT be excluded)
• The subject has active infection processes, that in the opinion of the investigator may compromise safety or study objectives
• The subject is known to have a pre-existing condition that may interfere with wound healing, e.g. malignancy, diabetes or autoimmune disease, immunocompromised blood borne diseases, has AIDS, is HIV or Hepatitis-A positive, or currently has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum)
• The subject has other concurrent conditions that in the opinion of the investigator may compromise safety or study objectives
• The subject has a known hypersensitivity to Trypsin and/or Compound Sodium Lactate for Irrigation (Hartmann's) solution
• The subject cannot be compliant with study procedures and that, in the investigator's opinion, would interfere with the study objectives

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.