MedTrace Logo

Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique

NCT02982096 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-04-10

No results posted yet for this study

Summary

The purpose of this study is to determine if healing occurs within 21 days of treatment with the use of the CellutomeTM device for fractional epidermal micro grafting compared with standard acellular techniques (creams and membrane dressings).

Healing will be determined by time to ≥90% epithelialization within 21 days of treatment. Cosmesis (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be compared to standard techniques without application of skin cells (epidermal grafts = acellular) and will be measured twelve months post treatment application, ± 6 months.

Conditions

  • Burn Wound

Interventions

DEVICE

Cellutome Device

Use of FDA approved Cellutome treatment on burn wounds

OTHER

Standard of Care

Acellular burn wound management

Sponsors & Collaborators

  • Lehigh Valley Hospital

    lead OTHER

Principal Investigators

  • Sigrid Blome-Eberwein, MD · Lehigh Valley Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-23
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02982096 on ClinicalTrials.gov