Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 2/17/2019 |
| Start Date: | April 18, 2014 |
| End Date: | October 1, 2020 |
| Contact: | Paul J Kim, DPM |
| Email: | paul.j.kim@gunet.georgetown.edu |
| Phone: | 202-444-0469 |
A Randomized, Prospective Trial Comparing the Clinical Outcomes for DermACELL® Compared With Integra® Bilayer Wound Matrix
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.
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.
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.
Inclusion Criteria:
1. male or female 18-90
2. who have a complex soft tissue defect that extends below subcutaneous tissue (exposed
fascia, ligament, tendon, muscle, or bone)
3. wounds that are either acute or chronic (nonhealing wounds greater than 4 weeks but
not greater than 2 years in duration)
4. wounds not amendable to primary closure as deemed by the surgeon
5. wounds that have been deemed by the surgeon that any residual infection has been or is
being treated upon entry into the clinical trial
6. requiring operative application of a dermoconductive agent
7. extremity wounds have adequate perfusion determined by: palpable pedal pulses,
dopplerable pulses, ankle brachial index of >0.7, or transcutaneous oximetry of >0.5
8. renally stable (i.e. CR<3.0, BUN>9.0, eGFR >60)
9. is able to comply to clinical trial requirements
Exclusion Criteria:
1. with a contraindication for the application of a xenograft or allograft
2. untreated infection of soft tissue or bone
3. untreated autoimmune connective tissue disorders
4. body mass index of ≥ 50
5. undergoing chemotherapy/radiation therapy
6. malignancy
7. active liver disease (e.g. hepatitis A-G),
8. previous wound care therapy that included any bioengineered alternative tissue or STSG
30 days prior to enrollment
9. pregnancy
10. enrolled in any other interventional clinical research trial
11. unable or unwilling to comply with study requirements
We found this trial at
1
site
Washington, District of Columbia 20007
Principal Investigator: Paul Kim, DPM
Phone: 202-444-3059
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