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

NCT03285698 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2020-03-11

No results posted yet for this study

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

Interventions

DEVICE

DermACELL®

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

DEVICE

Integra®

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

Sponsors & Collaborators

  • LifeNet Health

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Christopher Attinger, MD · Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-18
Primary Completion
2020-08-31
Completion
2020-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03285698 on ClinicalTrials.gov