- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283787
Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries
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
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32204
- Saint Vincent's Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form by subject or legally authorized representative.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female patients that are ≥ 21 years of age.
- Body Mass Index (BMI) <45.
At least one Stage 3 or 4 pressure injury (NPUAP Staging Guidelines) present at the Screening and/or Treatment Visit located in any of the following regions:
- Occipital
- Back
- Flank
- Upper Extremity
i. Arm ii. Elbow iii. Wrist iv. Hand e. Sacral f. Hip g. Gluteal h. Ischial i. Lower Extremity i. Leg ii. Knee iii. Ankle iv. Heel v. Foot
- Surface dimensions of pressure injury must be between 9 to 64 cm2 inclusive (as measured prior to treatment using a cm-scale ruler). The longest dimension must not exceed 10 cm; depth must not exceed 5 cm.
- Wound must be >5 cm from the anus if colostomy not performed.
- For lower extremity ulcers: Adequate arterial blood flow and perfusion near the site of the injury (the foot is warm to the touch and has palpable pulses), per Investigator judgement.
- Confirmed pressure injury versus moisture-associated skin damage or friction injury.
- Ability to maintain an intact occlusive dressing for 4-7 days with reinforcement without contamination of urine or stool.
- Confirmed fecal (Colostomy) and/or urine incontinence (Foley) maintenance/management, if necessary.
- Consent to off-loading (turns) from pressure sites a minimum of every 2 hours (if possible).
- Consent to sharp debridement of necrotic tissue in the wound bed unless the wound has already undergone debridement within 5 days prior to the Treatment Visit.
- For females of reproductive potential (defined as females ≤ 55 years of age): Negative pregnancy test required prior to surgical debridement per hospital procedures.
Exclusion Criteria:
- Surgical treatment of pressure injury 30 days prior to the Treatment Visit and/or pressure injury in previously irradiated areas.
- Inability to manage fecal and/or urine incontinence or patient refusal of its maintenance/management (as determined medically necessary). Patient may be rescreened and enrolled if urinary and/or fecal continence status or management change after failure to comply with requirement.
- Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.
- Currently treated for an active malignant disease.
- Prior diagnosis of active malignant disease, and is less than 1 year disease-free.
- History of malignancy within the wound.
- Presence of any conditions that are contraindicated with NPWT.
- Any condition associated with a wound healing abnormality (e.g.: connective tissue disorder or immune disorder).
- Dermatologic comorbid disease (e.g., cutis laxa or collagen vascular disease).
- Bleeding diathesis.
- Patients with primary treatment ulcers from burns (from exposure to high heat) or venous leg ulcers. A patient may have concomitant non-pressure ulcers present in non-pressure ulcer treatment regions.
- Received biological-based therapy in any pressure wound within 3 months of the Treatment Visit.
- Severe or significant hypoalbuminemia (albumin <2.5 g/dL, and/or pre-albumin <5 mg/dL), or hypoproteinemia (protein <6 g/dL).
- Moderate to severe anemia (Hgb <7 g/dL).
- Severely uncontrolled diabetes mellitus (defined as HA1C >12%).
- Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Subject report of previous participation in other interventional wound healing clinical investigation within 60 days prior to the Screening Visit.
- The subject has any physical or psychiatric condition that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
MicroMatrix® and Cytal™ Wound Matrix 2-Layer
|
MicroMatrix® and Cytal™ Wound Matrix 2-Layer
|
Active Comparator: Group 2
MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
|
MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
|
Active Comparator: Group 3
Negative Pressure Wound Therapy
|
Negative Pressure Wound Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Complete Epithelialization
Time Frame: 12 weeks
|
Number of participant wounds with complete epithelialization by 12 weeks.
Complete wound closure (epithelialization) determination based on PI assessment.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Complete Wound Epithelization
Time Frame: 12 weeks
|
Time to complete wound epithelization between groups.
|
12 weeks
|
Rate of Wound Epithelization
Time Frame: 12 weeks
|
Rate of wound epithelization between groups
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carol Bowen-Wells, MD, Saint Vincent's Medical Center Riverside
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA2016-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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