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

NCT03283787 | Completed Results FDA Device

• 1 other identifier: CA2016-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pressure Ulcers Stage III; Pressure Ulcer, Stage IV; Pressure Ulcer

Keywords

Pressure Ulcer; ACell; ACell MicroMatrix®; ACell Cytal™; Extracellular Matrix; Urinary Bladder Matrix; Wound

Outcome Measures

Primary Outcomes (1)

• Incidence of Complete Epithelialization

  Number of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment.

  12 weeks

Secondary Outcomes (2)

• Time to Complete Wound Epithelization

  12 weeks

• Rate of Wound Epithelization

  12 weeks

Study Arms (3)

Group 1

ACTIVE COMPARATOR

MicroMatrix® and Cytal™ Wound Matrix 2-Layer

Device: MicroMatrix® and Cytal™ Wound Matrix 2-Layer

Group 2

ACTIVE COMPARATOR

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

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

Group 3

ACTIVE COMPARATOR

Negative Pressure Wound Therapy

Device: Negative Pressure Wound Therapy

Interventions

MicroMatrix® and Cytal™ Wound Matrix 2-Layer DEVICE

MicroMatrix® and Cytal™ Wound Matrix 2-Layer

Group 1

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

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

Group 2

Negative Pressure Wound Therapy DEVICE

Negative Pressure Wound Therapy

Group 3

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• St Vincent's Hospital: collaborator

Study Sites (1)

Saint Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

MeSH Terms

Conditions

Pressure Ulcer; Wounds and Injuries

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Results Point of Contact

• Title: Allison Matthews
• Organization: Integra LifeSciences

allison.matthews@integralife.com

443-766-3869

Study Officials

• Carol Bowen-Wells, MD

  Saint Vincent's Medical Center Riverside

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 14, 2017
• Study Start: April 1, 2017
• Primary Completion: September 25, 2019
• Study Completion: December 23, 2019
• Last Updated: April 20, 2021
• Results First Posted: November 16, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)