Spots Global Cancer Trial Database for Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix

Study Description

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 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.

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 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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