Trial Outcomes & Findings for RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years (NCT NCT03624192)
NCT ID: NCT03624192
Last Updated: 2024-07-18
Results Overview
The primary effectiveness endpoint is time, in days, to complete closure (≥95% epithelialization by blinded assessor) of study donor sites confirmed at two consecutive visits.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
up to 4 weeks
Results posted on
2024-07-18
Participant Flow
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control. RECELL + Telfa™ Clear and Xeroform™ dressings 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 Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
Unit of analysis: Donor site
Participant milestones
| Measure |
RECELL
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
Control
very subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
|---|---|---|
|
Overall Study
STARTED
|
3 3
|
3 3
|
|
Overall Study
COMPLETED
|
2 2
|
2 2
|
|
Overall Study
NOT COMPLETED
|
1 1
|
1 1
|
Reasons for withdrawal
| Measure |
RECELL
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
Control
very subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
Baseline characteristics by cohort
| Measure |
Experimental: All Participants (Within Patient Control)
n=3 Participants
All subjects receive both RECELL and Control. Each subject serves as their own control.
|
|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
3.7 Years
STANDARD_DEVIATION 2.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 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
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 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
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 4 weeksThe primary effectiveness endpoint is time, in days, to complete closure (≥95% epithelialization by blinded assessor) of study donor sites confirmed at two consecutive visits.
Outcome measures
| Measure |
RECELL
n=3 Site
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
Control
n=3 Site
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
|---|---|---|
|
Time to Complete Closure
Subject 001
|
10 Days
|
10 Days
|
|
Time to Complete Closure
Subject 003
|
14 Days
|
11 Days
|
|
Time to Complete Closure
Subject 004
|
13 Days
|
13 Days
|
SECONDARY outcome
Timeframe: 4 weeksSubject will be asked which donor site (A or B) they prefer (if subject is less than 8 years of age parents will be asked)
Outcome measures
| Measure |
RECELL
n=3 Participants
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
Control
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
|---|---|---|
|
Donor Site Treatment Preference (Site A or Site B) Reported by Subject
RECELL
|
1 Participants
|
—
|
|
Donor Site Treatment Preference (Site A or Site B) Reported by Subject
Control
|
1 Participants
|
—
|
|
Donor Site Treatment Preference (Site A or Site B) Reported by Subject
No Response
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPhysician will be asked which donor site (A or B) they prefer
Outcome measures
| Measure |
RECELL
n=3 Participants
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
Control
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
|---|---|---|
|
Donor Site Treatment Preference (Site A or Site B) Reported by Physician
RECELL
|
1 Physician Response
|
—
|
|
Donor Site Treatment Preference (Site A or Site B) Reported by Physician
Control
|
0 Physician Response
|
—
|
|
Donor Site Treatment Preference (Site A or Site B) Reported by Physician
Unable to determine/no preference
|
2 Physician Response
|
—
|
SECONDARY outcome
Timeframe: Day 7Comparative Itching of study donor sites during 1st week post treatment by asking which site was itchier after treatment
Outcome measures
| Measure |
RECELL
n=3 Participants
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
Control
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
|---|---|---|
|
Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment
RECELL
|
0 Participants
|
—
|
|
Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment
Control
|
0 Participants
|
—
|
|
Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment
No difference/Can't tell
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 7 or 8Comparative pain of study donor sites during 1st week post treatment by asking the child which site was more painful since treatment
Outcome measures
| Measure |
RECELL
n=3 Participants
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
Control
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
|---|---|---|
|
Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment
RECELL
|
0 Participants
|
—
|
|
Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment
Control
|
0 Participants
|
—
|
|
Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment
No Pain at Either Donor SIte
|
1 Participants
|
—
|
|
Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment
No Difference/Can't Tell
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Data was not collected for subject 001
Blinded Evaluator Overall Opinion POSAS Score of study donor sites. The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar.
Outcome measures
| Measure |
RECELL
n=2 Participants
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
Control
n=2 Participants
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
|---|---|---|
|
Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)
Subject 003
|
2 Score on a scale
|
9 Score on a scale
|
|
Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)
Subject 004
|
2 Score on a scale
|
3 Score on a scale
|
SECONDARY outcome
Timeframe: Week 24Population: Data was not collected from subjects 001 and 004
Patient Overall Opinion POSAS Score of study donor sites(reported by subject 8 years of age or older, or by parent/guardian if subject less than 8 years of age). The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar.
Outcome measures
| Measure |
RECELL
n=1 Participants
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
Control
n=1 Participants
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
|---|---|---|
|
Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)
Subject 003
|
5 Score on a scale
|
10 Score on a scale
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through Week 52Investigator's (unblinded) assessment of healing at all RECELL-treated areas including study donor sites by direct observation
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 4Mean subject (or parent/guardian) reported study donor site pain prior to and after dressing changes. Faces Pain Scale-Revised (FPS-R) or Numeric Rated Pain Scale will be used based on the child's age. Both scales use a 10-point scale where 10 is the worst pain imaginable or very much pain.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 4Mean subject (or parent/guardian) reported study donor site itching score prior to dressing changes using the Itch Man Scale (0-4) where 4 represents itching most terribly
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 4Mean pain score associated with dressing changes at study donor sites assessed by the health care provider performing the dressing change using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The scale is scored in a range of 0-10 with 0 representing no pain.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 4 and 24Blinding effectiveness by asking the Blinded Evaluator which treatment they think the donor sites (A and B) received
Outcome measures
Outcome data not reported
Adverse Events
Experimental: All Participants (Within Patient Control)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: All Participants (Within Patient Control)
n=3 participants at risk
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfa™ Clear and Xeroform™ dressings
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
Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings
|
|---|---|
|
Injury, poisoning and procedural complications
Graft Loss 135cm2
|
33.3%
1/3 • Number of events 1 • 52 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place