Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix
Status unconfirmed · Not applicable
Conditions studied: Wounds, Chronic Wounds, Nonmalignant Condition
In brief
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 products is to apply over the wound surface and wait until the graft is well vascularized (granular bed/neodermis). At that point a split thickness skin graft can be applied over this area to cover and heal the wound. This study will determine whether human allograft or xenograft will create a durable neodermis that is more supportive of accepting of a split thickness skin graft. Patients who do not receive Split thickness skin grafts will be assigned to the second cohort for observation of healing rates.
Key facts
- Study ID
- NCT03285698
- Run by
- Georgetown University
- People needed
- 53
- Starts
- 2014-04-18
- Expected to finish
- 2020-10-01
- Last updated by the study team
- 2020-03-11
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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