Pressure Ulcer, Pressure Ulcers Stage III, Pressure Ulcer, Stage IV
Conditions
Keywords
Pressure Ulcer, ACell, ACell MicroMatrix®, ACell Cytal™, Extracellular Matrix, Urinary Bladder Matrix, Wound
Brief summary
The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 & 4 pressure ulcers using ACell products.
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.
Interventions
DEVICEMicroMatrix® and Cytal™ Wound Matrix 2-Layer
MicroMatrix® and Cytal™ Wound Matrix 2-Layer
DEVICEMicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
DEVICENegative Pressure Wound Therapy
Negative Pressure Wound Therapy
Sponsors
St Vincent's Hospital
Integra LifeSciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Complete Epithelialization | 12 weeks | Number of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Wound Epithelization | 12 weeks | Time to complete wound epithelization between groups. |
| Rate of Wound Epithelization | 12 weeks | Rate of wound epithelization between groups |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 MicroMatrix® and Cytal™ Wound Matrix 2-Layer | 20 |
| Group 2 MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT | 20 |
| Group 3 Negative Pressure Wound Therapy | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 11 Participants | 15 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 9 Participants | 5 Participants | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 9 Participants | 10 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 11 Participants | 9 Participants | 27 Participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 10 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 2 / 20 | 4 / 20 |
| other Total, other adverse events | 9 / 20 | 18 / 20 | 19 / 20 |
| serious Total, serious adverse events | 2 / 20 | 2 / 20 | 5 / 20 |
Outcome results
Primary
Incidence of Complete Epithelialization
Number of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MicroMatrix® and Cytal™ Wound Matrix 2-Layer | Incidence of Complete Epithelialization | 2 No of wounds w/ complete epithelization |
| MicroMatrix® and Cytal™ Wound Matrix 2-Layer Plus NPWT | Incidence of Complete Epithelialization | 1 No of wounds w/ complete epithelization |
| Negative Pressure Wound Therapyroup 3 | Incidence of Complete Epithelialization | 0 No of wounds w/ complete epithelization |
Secondary
Rate of Wound Epithelization
Rate of wound epithelization between groups
Time frame: 12 weeks
Population: The secondary outcome analysis was confounded due to the heterogeneity of the data and amplified by the small samples size. The study data heterogeneity resulted from the clinically distinct wounds and subject risk profiles that limited interpretability and utility. This challenge was validated by an independent third party review.
Secondary
Time to Complete Wound Epithelization
Time to complete wound epithelization between groups.
Time frame: 12 weeks
Population: The secondary outcome analysis was confounded due to the heterogeneity of the data and amplified by the small samples size. The study data heterogeneity resulted from the clinically distinct wounds and subject risk profiles that limited interpretability and utility. This challenge was validated by an independent third party review.