Trial Outcomes & Findings for StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects (NCT NCT05517902)

Last Updated: 2025-03-18

Results Overview

Confirmed complete wound closure is defined as complete skin re-epithelialization confirmed at 2 consecutive visits at least 2 weeks apart, but no later than Week 20. Percentage of participants whose burn healed after StrataGraft treatment without needing the doctor to treat the burn with skin cut from other parts of the patient's own body were reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1 participants

Primary outcome timeframe

Up to Week 12

Results posted on

2025-03-18

Participant Flow

Participant took part in the study at a single clinical site in the United States from 28 April 2023 to 9 May 2024.

Participant milestones

Participant milestones
Measure	2 to < 12 Years Age Group Cohort Single application of StrataGraft to 0.5% to 10% total body surface area (TBSA) on Day 1.	12 to ≤ 17 Years Age Group Cohort Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to Week 12

Population: Safety population included all participants who were enrolled and received StrataGraft.

Outcome measures

Outcome measures
Measure	2 to < 12 Years Age Group Cohort n=1 Participants Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.	12 to ≤ 17 Years Age Group Cohort Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.
Percentage of Participants Who Achieved Confirmed Complete Closure of StrataGraft Treatment Sites Without Autograft Within 12 Weeks of StrataGraft Application	100 percentage of participants	—

PRIMARY outcome

Timeframe: Up to Month 12

Population: Safety population included all participants who were enrolled and received StrataGraft.

An adverse event (AE) is any untoward or undesirable medical occurrence in a participant who is administered a study treatment, which does not necessarily have to have a causal relationship with this treatment. TEAEs are AEs with an onset date on or after the start of StrataGraft treatment.

Outcome measures

Outcome measures
Measure	2 to < 12 Years Age Group Cohort n=1 Participants Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.	12 to ≤ 17 Years Age Group Cohort Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	1 Participants	—

SECONDARY outcome

Timeframe: At Week 12

Population: Safety population included all participants who were enrolled and received StrataGraft.

Wound closure was evaluated through visual inspection by the investigator. Complete wound closure was defined as "complete re-epithelialization of the wound without drainage," confirmed at 2 consecutive visits at least 2 weeks apart.

Outcome measures

Outcome measures
Measure	2 to < 12 Years Age Group Cohort n=1 Participants Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.	12 to ≤ 17 Years Age Group Cohort Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.
Percentage of StrataGraft Treatment Sites Per Participant Closed at Week 12 Without Autograft Placement	100 percentage of treatment sites	—

SECONDARY outcome

Timeframe: Up to Week 12

Population: Safety population included all participants who were enrolled and received StrataGraft.

Complete wound closure was defined as "complete re-epithelialization of the wound without drainage," confirmed at two consecutive visits at least two weeks apart.

Outcome measures

Outcome measures
Measure	2 to < 12 Years Age Group Cohort n=1 Participants Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.	12 to ≤ 17 Years Age Group Cohort Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.
Number of Confirmed Complete Wound Closures of the StrataGraft Treatment Sites on or Before Week 12 Without Autograft Placement	1 number of complete wound closure	—

SECONDARY outcome

Timeframe: Up to Week 12

Population: Safety population included all participants who were enrolled and received StrataGraft. None of the participant had StrataGraft treatment site that required autografting.

Outcome measures

Outcome data not reported

Adverse Events

2 to < 12 Years Age Group Cohort

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

12 to ≤ 17 Years Age Group Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	2 to < 12 Years Age Group Cohort n=1 participants at risk Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.	12 to ≤ 17 Years Age Group Cohort Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.
Respiratory, thoracic and mediastinal disorders Atelectasis	100.0% 1/1 • Up to 12 months Safety population included all participants who were enrolled and received StrataGraft.	— 0/0 • Up to 12 months Safety population included all participants who were enrolled and received StrataGraft.
Infections and infestations Bronchitis	100.0% 1/1 • Up to 12 months Safety population included all participants who were enrolled and received StrataGraft.	— 0/0 • Up to 12 months Safety population included all participants who were enrolled and received StrataGraft.
Skin and subcutaneous tissue disorders Pruritus	100.0% 1/1 • Up to 12 months Safety population included all participants who were enrolled and received StrataGraft.	— 0/0 • Up to 12 months Safety population included all participants who were enrolled and received StrataGraft.
Skin and subcutaneous tissue disorders Rash	100.0% 1/1 • Up to 12 months Safety population included all participants who were enrolled and received StrataGraft.	— 0/0 • Up to 12 months Safety population included all participants who were enrolled and received StrataGraft.
Infections and infestations Wound infection	100.0% 1/1 • Up to 12 months Safety population included all participants who were enrolled and received StrataGraft.	— 0/0 • Up to 12 months Safety population included all participants who were enrolled and received StrataGraft.

Additional Information

Medical Information Call Center

Mallinckrodt

Phone: 1-800-844-2830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	2 to < 12 Years Age Group Cohort n=1 Participants Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.	12 to ≤ 17 Years Age Group Cohort Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants