Wounds
Conditions
Keywords
Wounds, ACell, ACell MicroMatrix®, ACell Cytal® Wound Matrix, Extracellular Matrix, Urinary Bladder Matrix
Brief summary
This is an observational study to assess the safety and efficacy of MicroMatrix® alone or in combination with Cytal® Wound Matrix on primary measures of wound healing.
Detailed description
A single-site, prospective, observational clinical study of Cytal® Wound Matrix alone or in combination with MicroMatrix® for the management of wounds. Up to 100 patients with multiple wound types including but not limited to, venous ulcers, diabetic foot ulcers, trauma wounds, and external surgical wounds will be treated either with Cytal® Wound Matrix alone or with Cytal® Wound Matrix and MicroMatrix® for wounds exceeding 3mm in depth. Wound healing efficacy, effect of treatment on patient-reported quality of life, complete wound management, wound-related adverse event, and wound pathology will be measured. The protocol defined patient follow-up is 12 months.
Interventions
DEVICEACell Arm
Cytal® Wound Matrix and/or MicroMatrix®
Sponsors
Winthrop University Hospital
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has at least one wound that the treating physician determines may be treated with Cytal® with or without MicroMatrix®. 2. Subject is at least 21 years of age. 3. Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen. 4. Subject or legal representative is willing to provide informed consent. 5. For females of reproductive potential, confirmed negative urine pregnancy test at enrollment.
Exclusion criteria
1. Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference. 2. Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study. 3. The subject has any condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study. 4. The subject's wound shows evidence of infection as determined by the Principal Investigator (which may be indicated by the presence of: elevated WBC, pus, moderate or greater discharge, abnormal odor, or acute osteomyelitis). 5. Wound with exposed organs or hardware. 6. Wound with burn etiology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Completely Healed Wounds | Up to 12 weeks | Assess number of participants with completely healed wounds, defined as 100% epithelialization with no drainage. |
| Wound Size Change | Up to 12 weeks | Assess wound size at specified intervals. Number of wounds with 40% reduction by week 4, 60% by week 8, and 80% by week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Bridging | up to 52 week visit (until study completion) | Bridging to definitive closure or transition to cellular therapy |
| Visual Analogue Scale (VAS) for Pain | Up to 52 week visit (until study completion) | VAS is a psychometric response scale that measures subjective characteristics or attitudes regarding perceived pain levels from participants. Participants are asked to draw a line on a 10cm horizontal line indicating what their current pain level would be. The distance between the start of the horizontal line to the vertical line is calculated in mm with a higher score (100mm) indicating a greater pain intensity. |
| Wound Quality of Life (W-QOL) | Up to 52 week visit (until study completion) | W-QOL is a 17-item Likert style questionnaire that measures 3 subscales in a participant (Body, Psyche, and Everyday to then calculate an overall global score. An overall global score is obtained from averaging all items. Each item is coded with numbers 0 (not at all) to 4 (very much) with a higher score indicating a lower quality of life. |
| Katz Index of Independence in Activities of Daily Living (KATZ ADL) | Up to 52 week visit (until study completion) | The Katz ADL is a 6-item questionnaire measuring independence in activities of daily living such as bathing, dressing, toileting, transfers, feeding, and continence. Each item is dichotomized as either having a score of zero (i.e dependence) or one (i.e. independence). An overall score of 6 indicates full function and an overall score of 2 or less indicates severe functional impairment |
| Complete Wound Management | up to 52 week visit (until study completion) | Assess the method of application of products and how it is secured as well as adjunctive treatments and dressing. |
| Wound-Related Adverse Events | up to 52 week visit (until study completion) | Number and type of wound-related adverse events as recorded on adverse event case report forms. |
| Time to Complete Wound Closure | up to 52 week visit (until study completion) | Determine time to complete wound closure using Silhouette Star camera system. |
| Wound Characteristics | up to 52 week visit (until study completion) | Identify wound characteristics as determined by granulation tissue quality and presence/quantity of exudate. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost Associated With AEs, UADEs and SAEs | up to 52 week visit (until study completion) | Measure frequency of wound specific events, capturing incident specific costs per event. |
| Wound Pathology | Up to 12 weeks | Measures the effect of treatment through quantitative analysis |
| Indirect Product and Care Costs | up to 52 week visit (until study completion) | Measures the total of the indirect and incidental costs |
| Return to Work Status | up to 52 week visit (until study completion) | Measures change in return to work status and/or reported work status |
| Direct Product and Care Costs | up to 52 week visit (until study completion) | Measures the direct cost of products |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACell Arm Cytal® Wound Matrix and/or MicroMatrix®
Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use.
MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use.
ACell Arm: Cytal® Wound Matrix and/or MicroMatrix® | 37 |
| Total | 37 |
Baseline characteristics
| Characteristic | ACell Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 37 |
| other Total, other adverse events | 17 / 37 |
| serious Total, serious adverse events | 6 / 37 |
Outcome results
Primary
Number of Participants With Completely Healed Wounds
Assess number of participants with completely healed wounds, defined as 100% epithelialization with no drainage.
Time frame: Up to 12 weeks
Population: The study was terminated by Sponsor prior to completion, all enrolled subjects did not complete 12 weeks follow-up prior to termination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ACell Arm | Number of Participants With Completely Healed Wounds | 4 Participants |
Primary
Wound Size Change
Assess wound size at specified intervals. Number of wounds with 40% reduction by week 4, 60% by week 8, and 80% by week 12.
Time frame: Up to 12 weeks
Population: Data was not collected and outcome measure analysis was not performed.
Secondary
Complete Wound Management
Assess the method of application of products and how it is secured as well as adjunctive treatments and dressing.
Time frame: up to 52 week visit (until study completion)
Population: Data was not collected and outcome measure analysis was not performed.
Secondary
Incidence of Bridging
Bridging to definitive closure or transition to cellular therapy
Time frame: up to 52 week visit (until study completion)
Population: Data was not collected and outcome measure analysis was not performed.
Secondary
Katz Index of Independence in Activities of Daily Living (KATZ ADL)
The Katz ADL is a 6-item questionnaire measuring independence in activities of daily living such as bathing, dressing, toileting, transfers, feeding, and continence. Each item is dichotomized as either having a score of zero (i.e dependence) or one (i.e. independence). An overall score of 6 indicates full function and an overall score of 2 or less indicates severe functional impairment
Time frame: Up to 52 week visit (until study completion)
Population: Data was not collected and outcome measure analysis was not performed.
Secondary
Time to Complete Wound Closure
Determine time to complete wound closure using Silhouette Star camera system.
Time frame: up to 52 week visit (until study completion)
Population: Data was not collected and outcome measure analysis was not performed.
Secondary
Visual Analogue Scale (VAS) for Pain
VAS is a psychometric response scale that measures subjective characteristics or attitudes regarding perceived pain levels from participants. Participants are asked to draw a line on a 10cm horizontal line indicating what their current pain level would be. The distance between the start of the horizontal line to the vertical line is calculated in mm with a higher score (100mm) indicating a greater pain intensity.
Time frame: Up to 52 week visit (until study completion)
Population: Data was not collected and outcome measure analysis was not performed.
Secondary
Wound Characteristics
Identify wound characteristics as determined by granulation tissue quality and presence/quantity of exudate.
Time frame: up to 52 week visit (until study completion)
Population: Data was not collected and outcome measure analysis was not performed.
Secondary
Wound Quality of Life (W-QOL)
W-QOL is a 17-item Likert style questionnaire that measures 3 subscales in a participant (Body, Psyche, and Everyday to then calculate an overall global score. An overall global score is obtained from averaging all items. Each item is coded with numbers 0 (not at all) to 4 (very much) with a higher score indicating a lower quality of life.
Time frame: Up to 52 week visit (until study completion)
Population: Data was not collected and outcome measure analysis was not performed.
Secondary
Wound-Related Adverse Events
Number and type of wound-related adverse events as recorded on adverse event case report forms.
Time frame: up to 52 week visit (until study completion)
Population: Data was not collected and outcome measure analysis was not performed.
Other Pre-specified
Cost Associated With AEs, UADEs and SAEs
Measure frequency of wound specific events, capturing incident specific costs per event.
Time frame: up to 52 week visit (until study completion)
Population: Data was not collected and outcome measure analysis was not performed.
Other Pre-specified
Direct Product and Care Costs
Measures the direct cost of products
Time frame: up to 52 week visit (until study completion)
Population: Data was not collected and outcome measure analysis was not performed.
Other Pre-specified
Indirect Product and Care Costs
Measures the total of the indirect and incidental costs
Time frame: up to 52 week visit (until study completion)
Population: Data was not collected and outcome measure analysis was not performed.
Other Pre-specified
Return to Work Status
Measures change in return to work status and/or reported work status
Time frame: up to 52 week visit (until study completion)
Population: Data was not collected and outcome measure analysis was not performed.
Other Pre-specified
Wound Pathology
Measures the effect of treatment through quantitative analysis
Time frame: Up to 12 weeks
Population: Data was not collected and outcome measure analysis was not performed.