Trial Outcomes & Findings for Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries (NCT NCT03283787)
NCT ID: NCT03283787
Last Updated: 2021-04-20
Results Overview
Number of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-04-20
Participant Flow
Participant milestones
| Measure |
MicroMatrix® and Cytal™ Wound Matrix 2-Layer
Treatment protocol per PI SOC discretion utilizing study devices.
|
MicroMatrix® and Cytal™ Wound Matrix 2-Layer Plus NPWT
Treatment protocol per PI SOC discretion utilizing study device plus NPWT.
|
Negative Pressure Wound Therapy
Treatment protocol per PI SOC discretion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries
Baseline characteristics by cohort
| Measure |
Group 1
n=20 Participants
MicroMatrix® and Cytal™ Wound Matrix 2-Layer
|
Group 2
n=20 Participants
MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
|
Group 3
n=20 Participants
Negative Pressure Wound Therapy
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeksNumber of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment.
Outcome measures
| Measure |
MicroMatrix® and Cytal™ Wound Matrix 2-Layer
n=20 Participants
Treatment protocol per PI discretion
|
MicroMatrix® and Cytal™ Wound Matrix 2-Layer Plus NPWT
n=20 Participants
Treatment protocol per PI discretion
|
Negative Pressure Wound Therapyroup 3
n=20 Participants
Treatment protocol per PI discretion
|
|---|---|---|---|
|
Incidence of Complete Epithelialization
|
2 No of wounds w/ complete epithelization
|
1 No of wounds w/ complete epithelization
|
0 No of wounds w/ complete epithelization
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
Time to complete wound epithelization between groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
Rate of wound epithelization between groups
Outcome measures
Outcome data not reported
Adverse Events
Group 1
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2
Serious events: 2 serious events
Other events: 18 other events
Deaths: 2 deaths
Group 3
Serious events: 5 serious events
Other events: 19 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Group 1
n=20 participants at risk
MicroMatrix® and Cytal™ Wound Matrix 2-Layer
|
Group 2
n=20 participants at risk
MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
|
Group 3
n=20 participants at risk
Negative Pressure Wound Therapy
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.0%
1/20 • Number of events 1 • 6 Months
|
5.0%
1/20 • Number of events 1 • 6 Months
|
10.0%
2/20 • Number of events 2 • 6 Months
|
|
General disorders
Blunt Trauma
|
0.00%
0/20 • 6 Months
|
5.0%
1/20 • Number of events 1 • 6 Months
|
0.00%
0/20 • 6 Months
|
|
Musculoskeletal and connective tissue disorders
Hip/Femur Fracture
|
5.0%
1/20 • Number of events 1 • 6 Months
|
0.00%
0/20 • 6 Months
|
5.0%
1/20 • Number of events 1 • 6 Months
|
|
General disorders
Seizure
|
0.00%
0/20 • 6 Months
|
0.00%
0/20 • 6 Months
|
5.0%
1/20 • Number of events 1 • 6 Months
|
|
General disorders
Complications related to pneumonia
|
0.00%
0/20 • 6 Months
|
0.00%
0/20 • 6 Months
|
5.0%
1/20 • Number of events 1 • 6 Months
|
|
General disorders
Peripheral Arterial Disease and End stage renal disease
|
0.00%
0/20 • 6 Months
|
0.00%
0/20 • 6 Months
|
5.0%
1/20 • Number of events 1 • 6 Months
|
Other adverse events
| Measure |
Group 1
n=20 participants at risk
MicroMatrix® and Cytal™ Wound Matrix 2-Layer
|
Group 2
n=20 participants at risk
MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
|
Group 3
n=20 participants at risk
Negative Pressure Wound Therapy
|
|---|---|---|---|
|
General disorders
Bleeding
|
0.00%
0/20 • 6 Months
|
0.00%
0/20 • 6 Months
|
5.0%
1/20 • Number of events 1 • 6 Months
|
|
Infections and infestations
Infection
|
25.0%
5/20 • Number of events 5 • 6 Months
|
45.0%
9/20 • Number of events 20 • 6 Months
|
60.0%
12/20 • Number of events 25 • 6 Months
|
|
Skin and subcutaneous tissue disorders
Periwound Maceration
|
25.0%
5/20 • Number of events 6 • 6 Months
|
75.0%
15/20 • Number of events 27 • 6 Months
|
95.0%
19/20 • Number of events 52 • 6 Months
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/20 • 6 Months
|
0.00%
0/20 • 6 Months
|
5.0%
1/20 • Number of events 1 • 6 Months
|
|
General disorders
Wound Recurrence
|
0.00%
0/20 • 6 Months
|
5.0%
1/20 • Number of events 1 • 6 Months
|
0.00%
0/20 • 6 Months
|
|
Gastrointestinal disorders
Wound contamination, secondary to diarrhea
|
5.0%
1/20 • Number of events 1 • 6 Months
|
0.00%
0/20 • 6 Months
|
0.00%
0/20 • 6 Months
|
|
General disorders
Wound Vac Leaking
|
0.00%
0/20 • 6 Months
|
0.00%
0/20 • 6 Months
|
5.0%
1/20 • Number of events 1 • 6 Months
|
|
General disorders
Lethargic
|
0.00%
0/20 • 6 Months
|
0.00%
0/20 • 6 Months
|
5.0%
1/20 • Number of events 1 • 6 Months
|
|
Endocrine disorders
Hypoglycemia and AMS
|
0.00%
0/20 • 6 Months
|
5.0%
1/20 • Number of events 1 • 6 Months
|
0.00%
0/20 • 6 Months
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 1 • 6 Months
|
0.00%
0/20 • 6 Months
|
0.00%
0/20 • 6 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place