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

Primary Purpose

Wounds, Chronic Wounds, Nonmalignant Condition

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DermACELL®

Integra®

About this trial

This is an interventional treatment trial for Wounds

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

male or female 18-90
who have a complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)
wounds that are either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 2 years in duration)
wounds not amendable to primary closure as deemed by the surgeon
wounds that have been deemed by the surgeon that any residual infection has been or is being treated upon entry into the clinical trial
requiring operative application of a dermoconductive agent
extremity wounds have adequate perfusion determined by: palpable pedal pulses, dopplerable pulses, ankle brachial index of >0.7, or transcutaneous oximetry of >0.5
renally stable (i.e. CR<3.0, BUN>9.0, eGFR >60)
is able to comply to clinical trial requirements

Exclusion Criteria:

with a contraindication for the application of a xenograft or allograft
untreated infection of soft tissue or bone
untreated autoimmune connective tissue disorders
body mass index of ≥ 50
undergoing chemotherapy/radiation therapy
malignancy
active liver disease (e.g. hepatitis A-G),
previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment
pregnancy
enrolled in any other interventional clinical research trial
unable or unwilling to comply with study requirements

Sites / Locations

Medstar Georgetown University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Integra®

DermACELL®

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03285698

First Posted

September 14, 2017

Last Updated

March 9, 2020

Sponsor

Georgetown University

Collaborators

LifeNet Health

1. Study Identification

Unique Protocol Identification Number

NCT03285698

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 18, 2014 (Actual)

Primary Completion Date

August 31, 2020 (Anticipated)

Study Completion Date

October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Georgetown University

Collaborators

LifeNet Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wounds, Chronic Wounds, Nonmalignant Condition

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Integra®

Arm Type

Other

Arm Description

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

Arm Title

DermACELL®

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

DermACELL®

Intervention Description

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

Intervention Name(s)

Integra®

Intervention Description

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

Primary Outcome Measure Information:

Title

Time the wound bed takes to heal for split thickness skin graft application

Description

Time Frame

160 days

Secondary Outcome Measure Information:

Title

Percentage of subjects with complete split thickness skin graft take

Description

Time Frame

30 days

Other Pre-specified Outcome Measures:

Title

Percentage of split thickness skin graft take for wound

Description

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 Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: male or female 18-90 who have a complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone) wounds that are either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 2 years in duration) wounds not amendable to primary closure as deemed by the surgeon wounds that have been deemed by the surgeon that any residual infection has been or is being treated upon entry into the clinical trial requiring operative application of a dermoconductive agent extremity wounds have adequate perfusion determined by: palpable pedal pulses, dopplerable pulses, ankle brachial index of >0.7, or transcutaneous oximetry of >0.5 renally stable (i.e. CR<3.0, BUN>9.0, eGFR >60) is able to comply to clinical trial requirements Exclusion Criteria: with a contraindication for the application of a xenograft or allograft untreated infection of soft tissue or bone untreated autoimmune connective tissue disorders body mass index of ≥ 50 undergoing chemotherapy/radiation therapy malignancy active liver disease (e.g. hepatitis A-G), previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment pregnancy enrolled in any other interventional clinical research trial unable or unwilling to comply with study requirements

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Attinger, MD

Organizational Affiliation

Georgetown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medstar Georgetown University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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