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Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries
NA trial testing MicroMatrix® and Cytal™ Wound Matrix 2-Layer in Pressure Ulcers Stage III in 60 participants. Completed in 23 December 2019.
| Lead sponsor | Integra LifeSciences Corporation |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 April 2017 |
| Primary completion | 25 September 2019 |
| Estimated completion | 23 December 2019 |
| Sites | 1 location across United States |
Integra LifeSciences Corporation — full company profile →
21 and older, any sex, with Pressure Ulcers Stage III or Pressure Ulcer, Stage IV. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment.
| Group | Value | 95% CI |
|---|---|---|
| MicroMatrix® and Cytal™ Wound Matrix 2-Layer | 2 | |
| MicroMatrix® and Cytal™ Wound Matrix 2-Layer Plus NPWT | 1 | |
| Negative Pressure Wound Therapyroup 3 | 0 |
Time frame: 6 Months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group 1 | Group 2 | Group 3 |
|---|---|---|---|---|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Blunt Trauma | General disorders | — | — | — |
| Hip/Femur Fracture | Musculoskeletal and connective tissue disorders | — | — | — |
| Seizure | General disorders | — | — | — |
| Complications related to pneumonia | General disorders | — | — | — |
| Peripheral Arterial Disease and End stage renal disease | General disorders | — | — | — |
| Reaction | System | Group 1 | Group 2 | Group 3 |
|---|---|---|---|---|
| Periwound Maceration | Skin and subcutaneous tissue disorders | — | — | — |
| Infection | Infections and infestations | — | — | — |
| Bleeding | General disorders | — | — | — |
| Skin Ulcer | Skin and subcutaneous tissue disorders | — | — | — |
| Wound Recurrence | General disorders | — | — | — |
| Wound contamination, secondary to diarrhea | Gastrointestinal disorders | — | — | — |
| Wound Vac Leaking | General disorders | — | — | — |
| Lethargic | General disorders | — | — | — |
| Hypoglycemia and AMS | Endocrine disorders | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — |
Most-reported serious reactions: Respiratory Failure, Blunt Trauma, Hip/Femur Fracture, Seizure, Complications related to pneumonia, Peripheral Arterial Disease and End stage renal disease.
Data from ClinicalTrials.gov NCT03283787 adverse events section.
The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 \& 4 pressure ulcers using ACell products.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03283787.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing