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Tissue Engineering

StrataGraft for Pediatric Burns (StrataSTEPS Trial)

Q: Is the eligibility for this experiment restricted to individuals over 80 years of age?

This clinical trial has set the minimum age for enrollment at two years old and a maximum of 17.

Q: Is this cohort of patients aged 2-12 years safe to administer treatments to?

Our team at Power has assessed the safety of 2 to &#x3C; 12 years Age Group Cohort as a 3 due to its phase 3 status, implying substantial evidence for both efficacy and safety.

Q: Is there an opportunity for individuals to partake in this trial presently?

According to the details posted on clinicaltrials.gov, this trial is still searching for volunteers and was uploaded to the site in December 2023. The data was recently updated at the end of January 2024.

Q: How many individuals are enrolled in the maximum capacity for this clinical trial?

Affirmative. The clinical trial data hosted on clinicaltrials.gov proves that this medical study, which was originally posted on January 31st 2023, is actively enrolling individuals in the experiment. 50 participants are needed from 1 research site.

Q: Can I join the ongoing trial?

50 individuals aged between 2 and 17 that have obtained dermabrasion can join this trial. To be eligible, participants must provide an informed written consent from their parent(s) or legal guardian(s), demonstrate they possess healthy skin to donate in the event of autografting needs, display thermal burns covering no more than 30% TBSA (total body surface area), present treatment sites with a DPT depth clinically indicated for excision and autografting located on the torso or extremities, indicate study treatment areas totaling 0.5%-10%, composed of 3 non-contiguous places found either on the same plane

Phase 3

Waitlist Available

Research Sponsored by Stratatech, a Mallinckrodt Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

StrataSTEPS Trial Summary

This trial evaluates a burn treatment that replaces painful skin grafts with one application of StrataGraft, with the hope of reducing scarring and other medical problems.

Who is the study for?

This trial is for children with severe burns who need skin grafts. It's open to kids aged 2-17 with thermal burns covering no more than 30% of their body, needing grafting on the torso or limbs. They must have enough healthy skin in case a traditional graft is needed later. Kids can't join if they've had cancer, certain medical conditions, received other recent treatments, are pregnant/breastfeeding, or have immune-suppressing treatments.Check my eligibility

What is being tested?

The trial tests StrataGraft as an alternative to autografting (using patient's own skin) for healing severe burns in kids. The goal is to see if it reduces the need for traditional grafts and helps wounds close effectively. Participants will receive one application of StrataGraft on up to three separate burn areas during this roughly 2.5-year study.See study design

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include pain at the treatment site, infection risk similar to standard grafts, scarring issues or allergic reactions to StrataGraft materials.

StrataSTEPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Percentage of Participants Achieving Confirmed Complete Closure of StrataGraft Treatment Sites without Autograft within 12 Weeks of StrataGraft Application

Secondary outcome measures

Mean Percent Area of StrataGraft Treatment Sites per Participant Autografted by Week 12

Mean Percent Area of StrataGraft Treatment Sites per Participant Closed at Week 12 Without Autograft Placement

Number of Confirmed Complete Wound Closures of the Strata Graft Treatment Sites on or Before Week 12 Without Autograft Placement

StrataSTEPS Trial Design

2Treatment groups

Experimental Treatment

Group I: 2 to < 12 years Age Group CohortExperimental Treatment1 Intervention

Participants of age 2 to < 12 years will receive a single application of StrataGraft to 0.5% to 10% total body surface area (TBSA) on Day 1.

Group II: 12 to ≤ 17 years Age Group CohortExperimental Treatment1 Intervention

Participants of age 12 to ≤ 17 years will receive a single application of StrataGraft to 0.5% to 10% TBSA on Day 1.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Stratatech, a Mallinckrodt CompanyLead Sponsor

8 Previous Clinical Trials

195 Total Patients Enrolled

2 Trials studying Dermabrasion

33 Patients Enrolled for Dermabrasion

Biomedical Advanced Research and Development AuthorityFED

81 Previous Clinical Trials

909,440 Total Patients Enrolled

Clinical Team LeaderStudy DirectorStratatech, a Mallinckrodt Company

23 Previous Clinical Trials

4,409 Total Patients Enrolled

Media Library

StrataGraft (Tissue Engineering) Clinical Trial Eligibility Overview. Trial Name: NCT05517902 — Phase 3

Dermabrasion Research Study Groups: 2 to < 12 years Age Group Cohort, 12 to ≤ 17 years Age Group Cohort

Dermabrasion Clinical Trial 2023: StrataGraft Highlights & Side Effects. Trial Name: NCT05517902 — Phase 3

StrataGraft (Tissue Engineering) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05517902 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility for this experiment restricted to individuals over 80 years of age?

"This clinical trial has set the minimum age for enrollment at two years old and a maximum of 17."

Answered by AI

Is this cohort of patients aged 2-12 years safe to administer treatments to?

"Our team at Power has assessed the safety of 2 to < 12 years Age Group Cohort as a 3 due to its phase 3 status, implying substantial evidence for both efficacy and safety."

Answered by AI

Is there an opportunity for individuals to partake in this trial presently?

"According to the details posted on clinicaltrials.gov, this trial is still searching for volunteers and was uploaded to the site in December 2023. The data was recently updated at the end of January 2024."

Answered by AI

How many individuals are enrolled in the maximum capacity for this clinical trial?

"Affirmative. The clinical trial data hosted on clinicaltrials.gov proves that this medical study, which was originally posted on January 31st 2023, is actively enrolling individuals in the experiment. 50 participants are needed from 1 research site."

Answered by AI

Can I join the ongoing trial?

"50 individuals aged between 2 and 17 that have obtained dermabrasion can join this trial. To be eligible, participants must provide an informed written consent from their parent(s) or legal guardian(s), demonstrate they possess healthy skin to donate in the event of autografting needs, display thermal burns covering no more than 30% TBSA (total body surface area), present treatment sites with a DPT depth clinically indicated for excision and autografting located on the torso or extremities, indicate study treatment areas totaling 0.5%-10%, composed of 3 non-contiguous places found either on the same plane"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

2023. "StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05517902.