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

NCT ID: NCT03285698

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-18
• Study Completion Date: 2020-10-01

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.

Conditions

Wounds; Chronic Wounds; Nonmalignant Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Integra®

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

Group Type: OTHER

Integra®

Intervention Type: DEVICE

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

DermACELL®

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

Group Type: EXPERIMENTAL

DermACELL®

Intervention Type: DEVICE

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

Interventions

DermACELL®

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

Intervention Type: DEVICE

Integra®

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LifeNet Health

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Attinger, M.D.

Chief, Division of Reconstructive Plastic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Attinger, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

2014-0061

Identifier Type: -

Identifier Source: org_study_id