An interventional study of DermACELL® and Integra® in Wounds, Chronic Wounds and Nonmalignant Condition, sponsored by Georgetown University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-03-11.
Sponsored by Georgetown University · Not applicable, Interventional, and Treatment
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.
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 subjects will be randomized into either the DermACELL® (n=50) or Integra® Bilayer Wound Matrix (n=50) treatment group. An interim analysis will be performed when both groups have enrolled 25 subjects. Subjects will receive either DermACELL® or Integra® Bilayer Wound Matrix in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic. Once the neodermis has been sufficiently generated, a split thickness skin graft (autograft or allograft) will be applied in the operating room. The split thickness skin graft application site will be then followed to observe viability.
Exclusion Criteria:
Integra® is a bilayer wound matrix made out of bovine tissue.
Device: Integra®
DermACELL® is a bilayer wound matrix made out of human tissue.
Device: DermACELL®
DermACELL® is a bilayer wound matrix made out of human tissue and is applied to the wound in standard of care fashion.
Integra® is a bilayer wound matrix made out of bovine tissue and is applied to the wound in standard of care fashion.
Time the wound bed takes to heal for split thickness skin graft application
Time (days) required for wound bed preparation (granular bed) for the application of a split thickness skin graft (autograft or allograft) after placement of DermACELL® as compared with Integra® Bilayer Wound Matrix.
Time frame: 160 days
Percentage of subjects with complete split thickness skin graft take
The percent of subjects with complete split thickness skin graft (autograft or allograft) take utilizing DermACELL® as compared with Integra® Bilayer Wound Matrix 30 days after split thickness skin graft application.
Time frame: 30 days
Percentage of split thickness skin graft take for wound
The percent of split thickness skin graft (autograft or allograft) take for a wound that receives DermACELL® as compared with Integra® Bilayer Wound Matrix 30 days after split thickness skin graft application.
Time frame: 30 days
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Georgetown University