Status:
UNKNOWN
Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
LifeNet Health
Conditions:
Wounds
Chronic Wounds
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Both DermACELL® and Integra® Bilayer Wound Matrix are indicated for deep soft tissue coverage and serve as a biological matrix for cellular migration. The current thinking about the utility of these p...
Detailed Description
This is a prospective, randomized, single site, clinical research trial comparing the clinical outcomes of DermACELL® compared with Integra® Bilayer Wound Matrix in dermal regeneration. A total of 100...
Eligibility Criteria
Inclusion
- male or female 18-90
- who have a complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)
- wounds that are either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 2 years in duration)
- wounds not amendable to primary closure as deemed by the surgeon
- wounds that have been deemed by the surgeon that any residual infection has been or is being treated upon entry into the clinical trial
- requiring operative application of a dermoconductive agent
- extremity wounds have adequate perfusion determined by: palpable pedal pulses, dopplerable pulses, ankle brachial index of \>0.7, or transcutaneous oximetry of \>0.5
- renally stable (i.e. CR\<3.0, BUN\>9.0, eGFR \>60)
- is able to comply to clinical trial requirements
Exclusion
- with a contraindication for the application of a xenograft or allograft
- untreated infection of soft tissue or bone
- untreated autoimmune connective tissue disorders
- body mass index of ≥ 50
- undergoing chemotherapy/radiation therapy
- malignancy
- active liver disease (e.g. hepatitis A-G),
- previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment
- pregnancy
- enrolled in any other interventional clinical research trial
- unable or unwilling to comply with study requirements
Key Trial Info
Start Date :
April 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03285698
Start Date
April 18 2014
End Date
October 1 2020
Last Update
March 11 2020
Active Locations (1)
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1
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007