Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2019-12-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 \& 4 pressure ulcers using ACell products.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers

NCT06999590

Pressure Ulcer Ulcer Ulcer, Pressure +1 more

RECRUITING PHASE4

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

NCT03285698

Wounds Chronic Wounds Nonmalignant Condition

UNKNOWN NA

A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers

NCT06453187

Diabetic Foot Ulcer Venous Leg Ulcer

RECRUITING NA

AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

NCT01084577

Leg Ulcer

COMPLETED PHASE4

Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers

NCT03476876

Diabetic Foot Ulcer Deep Diabetic Foot Ulcer

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pressure Ulcers Stage III Pressure Ulcer, Stage IV Pressure Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

MicroMatrix® and Cytal™ Wound Matrix 2-Layer

Group Type ACTIVE_COMPARATOR

MicroMatrix® and Cytal™ Wound Matrix 2-Layer

Intervention Type DEVICE

MicroMatrix® and Cytal™ Wound Matrix 2-Layer

Group 2

MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT

Group Type ACTIVE_COMPARATOR

MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT

Intervention Type DEVICE

MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT

Group 3

Negative Pressure Wound Therapy

Group Type ACTIVE_COMPARATOR

Negative Pressure Wound Therapy

Intervention Type DEVICE

Negative Pressure Wound Therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MicroMatrix® and Cytal™ Wound Matrix 2-Layer

Intervention Type DEVICE

MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT

Intervention Type DEVICE

Negative Pressure Wound Therapy

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Provision of signed and dated informed consent form by subject or legally authorized representative.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female patients that are ≥ 21 years of age.
4. Body Mass Index (BMI) \<45.
5. 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:

1. Occipital
2. Back
3. Flank
4. 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
6. 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.
7. Wound must be \>5 cm from the anus if colostomy not performed.
8. 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.
9. Confirmed pressure injury versus moisture-associated skin damage or friction injury.
10. Ability to maintain an intact occlusive dressing for 4-7 days with reinforcement without contamination of urine or stool.
11. Confirmed fecal (Colostomy) and/or urine incontinence (Foley) maintenance/management, if necessary.
12. Consent to off-loading (turns) from pressure sites a minimum of every 2 hours (if possible).
13. 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.
14. 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

1. Surgical treatment of pressure injury 30 days prior to the 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 (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.
3. Allergy or hypersensitivity to materials in porcine-based study products (per subject report) 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. Presence of any conditions that are contraindicated with NPWT.
8. Any condition associated with a wound healing abnormality (e.g.: connective tissue disorder or immune disorder).
9. Dermatologic comorbid disease (e.g., cutis laxa or collagen vascular disease).
10. Bleeding diathesis.
11. 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.
12. Received biological-based therapy in any pressure wound within 3 months of the Treatment Visit.
13. Severe or significant hypoalbuminemia (albumin \<2.5 g/dL, and/or pre-albumin \<5 mg/dL), or hypoproteinemia (protein \<6 g/dL).
14. Moderate to severe anemia (Hgb \<7 g/dL).
15. Severely uncontrolled diabetes mellitus (defined as HA1C \>12%).
16. Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
17. Subject report of previous participation in other interventional wound healing clinical investigation within 60 days prior to the Screening Visit.
18. 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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No