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Procedure

Standard of Care for Burns

N/A
Waitlist Available
Led By Sigrid Blome-Eberwein, MD
Research Sponsored by Lehigh Valley Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will compare the healing of wounds using the Cellutome device with standard acellular techniques.

Eligible Conditions
  • Burns

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Healing time comparison of the donor site wound at 12 months post baseline
Healing time comparison of the donor site wound at 12 months post baseline.
Secondary outcome measures
Comparison of chronic outcomes of therapy 12 months post baseline
Comparison of impact of therapy on time to healing as assessed by ≥90% epithelialization 12 months post baseline.
Comparison of visible scarring with the use of the CellutomeTM 12 months post baseline

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of CareExperimental Treatment1 Intervention
Standard of Care: Acellular wound management
Group II: Cellutome treatmentActive Control1 Intervention
Cellutome Device: Use of Cellutome on burn wounds

Find a Location

Who is running the clinical trial?

Lehigh Valley HospitalLead Sponsor
24 Previous Clinical Trials
16,718 Total Patients Enrolled
Sigrid Blome-Eberwein, MDPrincipal InvestigatorLehigh Valley Health Network

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique
2016. "Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02982096.
~1 spots leftby Apr 2025
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