NCT03283787CompletedNot Applicable
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
Integra LifeSciences Corporation1 site in 1 country60 target enrollmentStarted: April 1, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Incidence of Complete Epithelialization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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) <
- •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:
- •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
Arms & Interventions
Group 1
Active Comparator
MicroMatrix® and Cytal™ Wound Matrix 2-Layer
Intervention: MicroMatrix® and Cytal™ Wound Matrix 2-Layer (Device)
Group 2
Active Comparator
MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
Intervention: MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT (Device)
Group 3
Active Comparator
Negative Pressure Wound Therapy
Intervention: Negative Pressure Wound Therapy (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Time to Complete Wound Epithelization(12 weeks)
- Rate of Wound Epithelization(12 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Phase 3
Study of Efficacy and Safety of FRSW107 in Pediatric Patients With Severe Hemophilia ASevere Hemophilia ANCT06136507Jiangsu Gensciences lnc.76
Active, not recruiting
Phase 3
A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia AHemophilia ANCT06297655Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.60
Active, not recruiting
Phase 3
A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal InsulinDiabetesNCT06767748Gan & Lee Pharmaceuticals.620
Active, not recruiting
Phase 3
A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Insulin-naive Subjects With Type 2 Diabetes Mellitus (T2DM)DiabetesNCT06767735Gan & Lee Pharmaceuticals.580
Active, not recruiting
Phase 3
A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Type 2 Diabetes Mellitus Subjects (T2DM) Treated With Basal + Prandial InsulinDiabetesNCT06767761Gan & Lee Pharmaceuticals.580