Trial Outcomes & Findings for Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Spray Skin Applied Over Bilayered Wound Matrix (NCT NCT02469168)
NCT ID: NCT02469168
Last Updated: 2018-08-07
Results Overview
Number of patients with a treatment-related adverse events requiring surgical intervention prior to Week 12 post-treatment and all serious adverse event (SAE) occurrences throughout the study
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
Prior to or at 12 weeks
Results posted on
2018-08-07
Participant Flow
Participant milestones
| Measure |
ReCell
Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix
|
Control
Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
ReCell
Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix
|
Control
Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
|
|---|---|---|
|
Overall Study
Trial closed
|
1
|
0
|
Baseline Characteristics
Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Spray Skin Applied Over Bilayered Wound Matrix
Baseline characteristics by cohort
| Measure |
ReCell
n=1 Participants
Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix
|
Control
Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 0 • n=5 Participants
|
—
|
29 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Prior to or at 12 weeksPopulation: did not enroll any additional participants
Number of patients with a treatment-related adverse events requiring surgical intervention prior to Week 12 post-treatment and all serious adverse event (SAE) occurrences throughout the study
Outcome measures
| Measure |
ReCell
n=1 Participants
Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix
|
Control
Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
|
|---|---|---|
|
Number of Participants With Adverse Event
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Prior to or at 6 weeksPopulation: did not enroll any additional participants
Complete wound closure is defined as skin wound re-epithelialization at 95% or greater at treated wound site and donor sites confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.
Outcome measures
| Measure |
ReCell
n=1 Participants
Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix
|
Control
Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
|
|---|---|---|
|
Number of Participants With Confirmed Treatment Area Closure
|
1 Participants
|
0 Participants
|
Adverse Events
ReCell
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ReCell
n=1 participants at risk
Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix
|
Control
Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
|
|---|---|---|
|
Surgical and medical procedures
Graft Sloughing
|
100.0%
1/1 • Number of events 1 • 6 weeks and 24 weeks post-operation
Do not differ from clinicaltrials.gov definitions.
|
—
0/0 • 6 weeks and 24 weeks post-operation
Do not differ from clinicaltrials.gov definitions.
|
|
Surgical and medical procedures
Malodorous wound
|
100.0%
1/1 • Number of events 1 • 6 weeks and 24 weeks post-operation
Do not differ from clinicaltrials.gov definitions.
|
—
0/0 • 6 weeks and 24 weeks post-operation
Do not differ from clinicaltrials.gov definitions.
|
|
Surgical and medical procedures
Exudate around graft
|
100.0%
1/1 • Number of events 1 • 6 weeks and 24 weeks post-operation
Do not differ from clinicaltrials.gov definitions.
|
—
0/0 • 6 weeks and 24 weeks post-operation
Do not differ from clinicaltrials.gov definitions.
|
Additional Information
Jody Richardson, MSN, RN
Walter Reed National Military Medical Center
Phone: 301-295-7798
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place