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2 to < 12 years Age Group Cohort for Burns

University of Wisconsin-Madison, Madison, WI
Burns+3 More ConditionsStrataGraft - Biological
Eligibility
2 - 17
All Sexes

Study 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.

Eligible Conditions
  • Deep Partial Thickness Burn
  • Burns
  • Dermabrasion
  • Trauma Wound

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Phenylephrine
1
Self assembled skin substitute (SASS)
1
PluroGel

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Up to 12 months

Up to 12 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Up to 12 weeks
Percentage of Participants Achieving Confirmed Complete Closure of StrataGraft Treatment Sites without Autograft within 12 Weeks of StrataGraft Application
Week 12
Mean Percent Area of StrataGraft Treatment Site Autografted by Week 12
Transplantation, Autologous

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Phenylephrine
1
Self assembled skin substitute (SASS)
1
PluroGel

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

2 to < 12 years Age Group Cohort
1 of 2
12 to ≤ 17 years Age Group Cohort
1 of 2

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: 2 to < 12 years Age Group Cohort · No Placebo Group · Phase 3

2 to < 12 years Age Group Cohort
Biological
Experimental Group · 1 Intervention: StrataGraft · Intervention Types: Biological
12 to ≤ 17 years Age Group Cohort
Biological
Experimental Group · 1 Intervention: StrataGraft · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

Stratatech, a Mallinckrodt CompanyLead Sponsor
8 Previous Clinical Trials
170 Total Patients Enrolled
5 Trials studying Burns
159 Patients Enrolled for Burns
Biomedical Advanced Research and Development AuthorityFED
64 Previous Clinical Trials
101,279 Total Patients Enrolled
3 Trials studying Burns
184 Patients Enrolled for Burns
Clinical Team LeaderStudy DirectorStratatech, a Mallinckrodt Company
23 Previous Clinical Trials
4,571 Total Patients Enrolled
2 Trials studying Burns
111 Patients Enrolled for Burns

Eligibility Criteria

Age 2 - 17 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have enough healthy skin that can be used as a backup plan in case skin grafting is needed.
The study requires treatment sites that are deep enough and located on the torso or limbs, where surgical removal and replacement with skin from your own body is medically necessary.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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