Trial Outcomes & Findings for RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years (NCT NCT03626701)
NCT ID: NCT03626701
Last Updated: 2024-07-30
Results Overview
Day 10 healing will be evaluated by an observer blinded to treatment allocation with confirmation at Day 28
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
10 Days post-treatment
Results posted on
2024-07-30
Participant Flow
Participant milestones
| Measure |
RECELL® Autologous Cell Harvesting Device
RECELL + Telfa™ Clear and Xeroform™ dressings
Conventional autografting (only when indicated)
RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
Mepilex® Ag Wound Dressing
Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated)
Mepilex® Ag Wound Dressing: Application of Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
6
|
|
Overall Study
COMPLETED
|
9
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years
Baseline characteristics by cohort
| Measure |
RECELL® Autologous Cell Harvesting Device
n=13 Participants
RECELL + Telfa™ Clear and Xeroform™ dressings
Conventional autografting (only when indicated)
RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
Mepilex® Ag Wound Dressing
n=6 Participants
Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated)
Mepilex® Ag Wound Dressing: Application of Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.0 years
STANDARD_DEVIATION 5.92 • n=5 Participants
|
6.5 years
STANDARD_DEVIATION 3.78 • n=7 Participants
|
8.9 years
STANDARD_DEVIATION 5.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 Days post-treatmentDay 10 healing will be evaluated by an observer blinded to treatment allocation with confirmation at Day 28
Outcome measures
| Measure |
RECELL® Autologous Cell Harvesting Device
n=13 Participants
RECELL + Telfa™ Clear and Xeroform™ dressings
Conventional autografting (only when indicated)
RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
Mepilex® Ag Wound Dressing
n=5 Participants
Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated)
Mepilex® Ag Wound Dressing: Application of Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
|---|---|---|
|
Incidence of Index Burns With Day 10 Healing
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 21, confirmed on Day 28Incidence of Day 21 healing of the Index Burn confirmed on Day 28
Outcome measures
| Measure |
RECELL® Autologous Cell Harvesting Device
n=12 Participants
RECELL + Telfa™ Clear and Xeroform™ dressings
Conventional autografting (only when indicated)
RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
Mepilex® Ag Wound Dressing
n=4 Participants
Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated)
Mepilex® Ag Wound Dressing: Application of Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
|---|---|---|
|
Incidence of Day 21 Healing of the Index Burn
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Through Day 28Incidence of conventional autografting to achieve healing of the Index Burn
Outcome measures
| Measure |
RECELL® Autologous Cell Harvesting Device
n=13 Participants
RECELL + Telfa™ Clear and Xeroform™ dressings
Conventional autografting (only when indicated)
RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
Mepilex® Ag Wound Dressing
n=6 Participants
Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated)
Mepilex® Ag Wound Dressing: Application of Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
|---|---|---|
|
Incidence of Conventional Autografting to Achieve Healing of the Index Burn
|
0 Participants
|
0 Participants
|
Adverse Events
RECELL® Autologous Cell Harvesting Device
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Mepilex® Ag Wound Dressing
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RECELL® Autologous Cell Harvesting Device
n=13 participants at risk
RECELL + Telfa™ Clear and Xeroform™ dressings
Conventional autografting (only when indicated)
RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
Mepilex® Ag Wound Dressing
n=6 participants at risk
Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated)
Mepilex® Ag Wound Dressing: Application of Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Impaired Healing
|
0.00%
0/13 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Injury
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
Other adverse events
| Measure |
RECELL® Autologous Cell Harvesting Device
n=13 participants at risk
RECELL + Telfa™ Clear and Xeroform™ dressings
Conventional autografting (only when indicated)
RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
Mepilex® Ag Wound Dressing
n=6 participants at risk
Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated)
Mepilex® Ag Wound Dressing: Application of Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice
|
|---|---|---|
|
General disorders
Impaired Healing
|
7.7%
1/13 • Number of events 1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Community Acquired Infection
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Skin Infection
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Injury, poisoning and procedural complications
Injury
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hypertrophic Scar
|
7.7%
1/13 • Number of events 1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.1%
3/13 • Number of events 3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place