Trial Outcomes & Findings for Cytal® Wound Matrix and MicroMatrix® Wound Study (NCT NCT03632954)
NCT ID: NCT03632954
Last Updated: 2021-05-11
Results Overview
Assess number of participants with completely healed wounds, defined as 100% epithelialization with no drainage.
TERMINATED
37 participants
Up to 12 weeks
2021-05-11
Participant Flow
Participant milestones
| Measure |
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®
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cytal® Wound Matrix and MicroMatrix® Wound Study
Baseline characteristics by cohort
| Measure |
ACell Arm
n=37 Participants
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®
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: The study was terminated by Sponsor prior to completion, all enrolled subjects did not complete 12 weeks follow-up prior to termination.
Assess number of participants with completely healed wounds, defined as 100% epithelialization with no drainage.
Outcome measures
| Measure |
ACell Arm
n=23 Participants
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®
|
|---|---|
|
Number of Participants With Completely Healed Wounds
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Data was not collected and outcome measure analysis was not performed.
Assess wound size at specified intervals. Number of wounds with 40% reduction by week 4, 60% by week 8, and 80% by week 12.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 52 week visit (until study completion)Population: Data was not collected and outcome measure analysis was not performed.
Determine time to complete wound closure using Silhouette Star camera system.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 52 week visit (until study completion)Population: Data was not collected and outcome measure analysis was not performed.
Identify wound characteristics as determined by granulation tissue quality and presence/quantity of exudate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 52 week visit (until study completion)Population: Data was not collected and outcome measure analysis was not performed.
Bridging to definitive closure or transition to cellular therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 week visit (until study completion)Population: Data was not collected and outcome measure analysis was not performed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 week visit (until study completion)Population: Data was not collected and outcome measure analysis was not performed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 week visit (until study completion)Population: Data was not collected and outcome measure analysis was not performed.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 52 week visit (until study completion)Population: Data was not collected and outcome measure analysis was not performed.
Assess the method of application of products and how it is secured as well as adjunctive treatments and dressing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 52 week visit (until study completion)Population: Data was not collected and outcome measure analysis was not performed.
Number and type of wound-related adverse events as recorded on adverse event case report forms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 52 week visit (until study completion)Population: Data was not collected and outcome measure analysis was not performed.
Measures the direct cost of products
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 52 week visit (until study completion)Population: Data was not collected and outcome measure analysis was not performed.
Measures the total of the indirect and incidental costs
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 52 week visit (until study completion)Population: Data was not collected and outcome measure analysis was not performed.
Measures change in "return to work status" and/or "reported work status"
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 52 week visit (until study completion)Population: Data was not collected and outcome measure analysis was not performed.
Measure frequency of wound specific events, capturing incident specific costs per event.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 weeksPopulation: Data was not collected and outcome measure analysis was not performed.
Measures the effect of treatment through quantitative analysis
Outcome measures
Outcome data not reported
Adverse Events
ACell Arm
Serious adverse events
| Measure |
ACell Arm
n=37 participants at risk
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®
|
|---|---|
|
General disorders
inpatient wound management
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Infections and infestations
abdominal pain/septic shock
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Infections and infestations
bacteremia
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Infections and infestations
discharge at device application site
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Infections and infestations
urinary tract infection/sepsis
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
accidental fall
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath/cough
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Surgical and medical procedures
scheduled surgery and hospitalization
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
Other adverse events
| Measure |
ACell Arm
n=37 participants at risk
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®
|
|---|---|
|
Cardiac disorders
atrial fibrillation
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
General disorders
bleeding at wound site
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
General disorders
hematoma at device application site
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
General disorders
increase in wound size
|
16.2%
6/37 • Number of events 7 • 52 weeks
|
|
General disorders
inflammation at device application site
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
General disorders
malaise
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
General disorders
near syncope episode
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
General disorders
pain at application site, discharge at application site
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
General disorders
pain at device application site (excessive or exacerbated)
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Infections and infestations
cellulitis at device application site
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Infections and infestations
cellulitis, leg
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Infections and infestations
conjunctivitis
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Infections and infestations
osteomyelitis at device application site
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Infections and infestations
urinary tract infection
|
2.7%
1/37 • Number of events 2 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
wrist injury
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
burning sensation
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
facial rash
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
rash
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
seroma
|
8.1%
3/37 • Number of events 4 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
skin maceration
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
small maculopapular rash (possible reaction to complex wound dressing)
|
2.7%
1/37 • Number of events 1 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
wound necrosis
|
5.4%
2/37 • Number of events 2 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place