Wounds and Injuries

All Conditions

Neoplasms

Rare Diseases

Precancerous Conditions

Chronic Graft Versus Host Disease

Integra® is a bilayer wound matrix made out of bovine tissue.

DermACELL® is a bilayer wound matrix made out of human tissue.

DermACELL® is a bilayer wound matrix made out of human tissue and is applied to the wound in standard of care fashion.

DermACELL®

Integra® is a bilayer wound matrix made out of bovine tissue and is applied to the wound in standard of care fashion.

Integra®

Christopher Attinger, MD

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.

Photographs are submitted and evaluated by a blind, independent assessor.

Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix

A Randomized, Prospective Trial Comparing the Clinical Outcomes for DermACELL® Compared With Integra® Bilayer Wound Matrix

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 (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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix	NCT03285698	Wounds Chronic Wounds Nonmalignant Co...	DermACELL® Integra®	18 Years - 90 Years	Georgetown University
Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix	NCT03285698	Wounds Chronic Wounds Nonmalignant Co...	DermACELL® Integra®	18 Years - 90 Years	Georgetown University

Spots Global Cancer Trial Database for integra®

Every month we try and update this database with for integra® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for integra®

Every month we try and update this database with for integra® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for integra® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.