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

NCT03285698 | Unknown DMC FDA Device

• 1 other identifier: 2014-0061
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds; Chronic Wounds; Nonmalignant Condition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of subjects with complete split thickness skin graft take

  30 days

Other Outcomes (1)

• Percentage of split thickness skin graft take for wound

  30 days

Study Arms (2)

Integra®

OTHER

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

Device: Integra®

DermACELL®

EXPERIMENTAL

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

Device: DermACELL®

Interventions

DermACELL® DEVICE

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

DermACELL®

Integra® DEVICE

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

Integra®

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• LifeNet Health: collaborator

Study Sites (1)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Precancerous Conditions

Condition Hierarchy (Ancestors)

Neoplasms

Study Officials

• Christopher Attinger, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Photographs are submitted and evaluated by a blind, independent assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Reconstructive Plastic Surgery

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: April 18, 2014
• Primary Completion: August 31, 2020
• Study Completion: October 1, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

US (1)