Pressure Ulcers Stage IIINCT03283787
Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries
A study testing MicroMatrix® and Cytal™ Wound Matrix 2-Layer, MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT and Negative Pressure Wound Therapy in people with Pressure Ulcers Stage III and Pressure Ulcer, Stage IV, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 \& 4 pressure ulcers using ACell products. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pressure Ulcers Stage III, Pressure Ulcer, Stage IV, Pressure Ulcer
- What is being tested?
- MicroMatrix® and Cytal™ Wound Matrix 2-Layer, MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT and Negative Pressure Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Back
- Flank
- Upper Extremity
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Vincent's Medical Center
Jacksonville, Florida, 32204
About this study
Official title: 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
The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 \& 4 pressure ulcers using ACell products.
Read the 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.
- Being tested
- MicroMatrix® and Cytal™ Wound Matrix 2-Layer, MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT, Negative Pressure Wound Therapy
- Keywords
- Pressure Ulcer, ACell, ACell MicroMatrix®, ACell Cytal™, Extracellular Matrix, Urinary Bladder Matrix, Wound
- Medical subject headings
- Pressure Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroMatrix® and Cytal™ Wound Matrix 2-LayerDevice
MicroMatrix® and Cytal™ Wound Matrix 2-Layer
MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWTDevice
MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
Negative Pressure Wound TherapyDevice
Negative Pressure Wound Therapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | MicroMatrix® and Cytal™ Wound Matrix 2-Layer Receives: Device: MicroMatrix® and Cytal™ Wound Matrix 2-Layer |
| Group 2 | Active comparator | MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT Receives: Device: MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT |
| Group 3 | Active comparator | Negative Pressure Wound Therapy Receives: Device: Negative Pressure Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Complete Epithelialization
Number of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment.
Measured: 12 weeks
Secondary outcomes (2)
Time to Complete Wound Epithelization
Time to complete wound epithelization between groups.
Measured: 12 weeks
Rate of Wound Epithelization
Rate of wound epithelization between groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start1 Apr 2017
- Primary completion25 Sep 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure Ulcers Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St Vincent's Hospital
- Responsible party
- Sponsor
- Investigators
- Carol Bowen-Wells, MD, Principal investigator, Saint Vincent's Medical Center Riverside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283787
- Sponsor's protocol ID
- CA2016-001
- Status last verified
- Mar 2021
- First submitted
- 13 Sep 2017
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03283787
- Acronym / sponsor ID
- CA2016-001
- Keywords
- Pressure Ulcer, ACell, ACell MicroMatrix®, ACell Cytal™, Extracellular Matrix, Urinary Bladder Matrix, Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- St Vincent's Hospital
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Posted 16 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: MicroMatrix® and Cytal™ Wound Matrix 2-LayerMicroMatrix® and Cytal™ Wound Matrix 2-Layer |
| Group 2 | Active comparator | Device: MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWTMicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT |
| Group 3 | Active comparator | Device: Negative Pressure Wound TherapyNegative Pressure Wound Therapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroMatrix® and Cytal™ Wound Matrix 2-LayerMicroMatrix® and Cytal™ Wound Matrix 2-Layer | Device | Group 1 |
| MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWTMicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT | Device | Group 2 |
| Negative Pressure Wound TherapyNegative Pressure Wound Therapy | Device | Group 3 |
Primary outcome
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.
2 secondary outcomes
Time to Complete Wound Epithelization
Time frame: 12 weeks
Rate of Wound Epithelization
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
Related trials for Pressure Ulcers Stage III
Not yet recruitingEarly Phase 1
Efficacy of a Polyhexanide Biguanide-Based Gel in the Prevention of Biofilm Formation in Pressure Ulcers
Pressure Ulcers, Pressure Ulcers Stage III
Recruiting
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
Pressure Ulcers Stage II, Pressure Ulcers Stage III
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Bowen-Wells, MD principal investigator
Saint Vincent's Medical Center Riverside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MicroMatrix® and Cytal™ Wound Matrix 2-Layer, MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT and Negative Pressure Wound Therapy in people with Pressure Ulcers Stage III and Pressure Ulcer, Stage IV, run by Integra LifeSciences Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Complete Epithelialization (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.