Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Wounds | — | UNRESOLVED | — |
| Nonmalignant Condition | — | UNRESOLVED | — |
| Wounds | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DermACELL® | Device | — | UNRESOLVED |
| Integra® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Integra®
- description
- Integra® is a bilayer wound matrix made out of bovine tissue.
- interventionNames
- Device: Integra®
- type
- EXPERIMENTAL
- label
- DermACELL®
- description
- DermACELL® is a bilayer wound matrix made out of human tissue.
- interventionNames
- Device: DermACELL®
Primary outcomes (1)
- measure
- Time the wound bed takes to heal for split thickness skin graft application
- timeFrame
- 160 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available