Trial Outcomes & Findings for StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT ) (NCT NCT04123548)
NCT ID: NCT04123548
Last Updated: 2023-11-09
Results Overview
An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. A TEAE is defined as an adverse event that started on or after the start of treatment (i.e. placement of StrataGraft).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
52 participants
Primary outcome timeframe
AEs were collected on each individual participant for the duration of their study participation, i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
Results posted on
2023-11-09
Participant Flow
Participants took part in the study across 10 study sites in the United States (US) from 21 February 2020 to 26 January 2022.
A total of 60 participants were screened of which, 52 participants were enrolled in the study.
Participant milestones
| Measure |
StrataGraft
On Day 1, participants received a single application of up to 1:1 meshed StrataGraft skin tissue on up to 3 deep partial thickness (DPT) wound(s) totaling no more than approximately 2000 square centimeters (cm\^2) in area.
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
StrataGraft
On Day 1, participants received a single application of up to 1:1 meshed StrataGraft skin tissue on up to 3 deep partial thickness (DPT) wound(s) totaling no more than approximately 2000 square centimeters (cm\^2) in area.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Death
|
4
|
|
Overall Study
Reason Not Specified
|
1
|
Baseline Characteristics
StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )
Baseline characteristics by cohort
| Measure |
StrataGraft
n=52 Participants
On Day 1, participants received a single application of up to 1:1 meshed StrataGraft skin tissue on up to 3 DPT wound(s) totaling no more than approximately 2000 cm\^2 in area.
|
|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 17.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: AEs were collected on each individual participant for the duration of their study participation, i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).Population: mITT population included all participants who were enrolled and received StrataGraft.
An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. A TEAE is defined as an adverse event that started on or after the start of treatment (i.e. placement of StrataGraft).
Outcome measures
| Measure |
StrataGraft
n=52 Participants
On Day 1, participants received a single application of up to 1:1 meshed StrataGraft skin tissue on up to 3 DPT wound(s) totaling no more than approximately 2000 cm\^2 in area.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
46 Participants
|
Adverse Events
StrataGraft
Serious events: 10 serious events
Other events: 35 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
StrataGraft
n=52 participants at risk
On Day 1, participants received a single application of up to 1:1 meshed StrataGraft skin tissue on up to 3 DPT wound(s) totaling no more than approximately 2000 cm\^2 in area.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Infections and infestations
Intervertebral discitis
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Infections and infestations
Pneumonia bacterial
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Infections and infestations
Pneumonia staphylococcal
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Infections and infestations
Septic shock
|
3.8%
2/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Infections and infestations
Wound infection
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Injury, poisoning and procedural complications
Intentional self-injury
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Nervous system disorders
Nervous system disorder
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Vascular disorders
Myocardial infarction
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Vascular disorders
Pulmonary embolism
|
1.9%
1/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
Other adverse events
| Measure |
StrataGraft
n=52 participants at risk
On Day 1, participants received a single application of up to 1:1 meshed StrataGraft skin tissue on up to 3 DPT wound(s) totaling no more than approximately 2000 cm\^2 in area.
|
|---|---|
|
Blood and lymphatic system disorders
Blood Loss anaemia
|
5.8%
3/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Gastrointestinal disorders
Constipation
|
9.6%
5/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
General disorders
Pain
|
11.5%
6/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Nervous system disorders
Neuralgia
|
9.6%
5/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Psychiatric disorders
Delirium
|
5.8%
3/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Skin and subcutaneous tissue disorders
Blister
|
9.6%
5/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
5.8%
3/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
42.3%
22/52 • AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place