Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries
| Status: | Recruiting |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Gastrointestinal |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Gastroenterology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 9/15/2017 |
| Start Date: | April 1, 2017 |
| End Date: | December 2018 |
| Contact: | Jessica Warren, RN, MA |
| Email: | jessicawarren@acell.com |
| Phone: | 443-283-2885 |
A Single Site Randomized, Clinical Trial Comparing the Concomitant Use of MicroMatrix® With Cytal™ Wound Matrix 2-Layer to Standard of Care in Patients With Stage 3 or 4 Pressure Injuries
The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 &
4 pressure ulcers using ACell products.
4 pressure ulcers using ACell products.
A three arm, parallel-design, randomized study comparing 2 experimental arms to a single
control arm. The primary comparison will be Group 1 (MicroMatrix® and ACell Cytal™ Wound
Matrix 2-Layer vs. Group 3 (NPWT) to determine if Group 1 is superior to Group 3. NPWT is the
standard of care (SOC) for patients with Stage 3 or 4 pressure ulcers and is the active
control arm for the study.
A secondary comparison will be conducted comparing Group 2 (MicroMatrix® and ACell Cytal™
Wound Matrix 2-Layer plus NPWT) vs. Group 3 (NPWT) to determine if Group 2 is superior to
Group 3.
control arm. The primary comparison will be Group 1 (MicroMatrix® and ACell Cytal™ Wound
Matrix 2-Layer vs. Group 3 (NPWT) to determine if Group 1 is superior to Group 3. NPWT is the
standard of care (SOC) for patients with Stage 3 or 4 pressure ulcers and is the active
control arm for the study.
A secondary comparison will be conducted comparing Group 2 (MicroMatrix® and ACell Cytal™
Wound Matrix 2-Layer plus NPWT) vs. Group 3 (NPWT) to determine if Group 2 is superior to
Group 3.
Inclusion Criteria:
1. Male or female patients that are ≥ 21 years of age.
2. Body Mass Index (BMI) <45.
3. At least one Stage 3 or 4 pressure injury (NPUAP Staging Guidelines) present at the
Screening and/or Treatment Visit.
4. Surface dimensions of pressure injury must be between 9 to 64 cm2 inclusive. The
longest dimension must not exceed 10 cm; depth must not exceed 5 cm.
5. Wound must be >5 cm from the anus if colostomy not performed.
6. For lower extremity ulcers: Adequate arterial blood flow and perfusion near the site
of the injury.
7. Confirmed pressure injury versus moisture-associated skin damage or friction injury.
8. Negative pregnancy test required.
Exclusion Criteria:
1. Surgical treatment of pressure injury 30 days prior to Treatment Visit and/or pressure
injury in previously irradiated areas.
2. Inability to manage fecal and/or urine incontinence or patient refusal of its
maintenance/management.
3. Allergy or hypersensitivity to materials in porcine-based study products or personal
preference.
4. Currently treated for an active malignant disease.
5. Prior diagnosis of active malignant disease, and is less than 1 year disease-free.
6. History of malignancy within the wound.
7. Bleeding diathesis.
8. Received biological-based therapy in any pressure wound within 3 months of the
Treatment Visit.
9. Severe or significant hypoalbuminemia or hypoproteinemia.
10. Moderate to severe anemia.
11. Severely uncontrolled diabetes mellitus.
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