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

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.

Study Overview

• Status: Unknown
• Conditions: Wounds; Chronic Wounds; Nonmalignant Condition
• Intervention / Treatment: Device: Integra®; Device: DermACELL®

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.

• Study Type: Interventional
• Enrollment (Anticipated): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Integra®; Integra® is a bilayer wound matrix made out of bovine tissue.	Device: Integra®; Integra® is a bilayer wound matrix made out of bovine tissue and is applied to the wound in standard of care fashion.
Experimental: DermACELL®; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	160 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: LifeNet Health
• Investigators: Principal Investigator: Christopher Attinger, MD, Georgetown University

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2014
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Wounds and Injuries; Precancerous Conditions
• Other Study ID Numbers: 2014-0061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No