MedTrace Logo

RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years

NCT03626701 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-07-30

Study results available
· View outcomes & findings →

Summary

A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a standardized wound dressing.

Conditions

  • Burns

Interventions

DEVICE

RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device

Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.

COMBINATION_PRODUCT

Mepilex® Ag Wound Dressing

Application of Mepilex® Ag Wound Dressing

PROCEDURE

Conventional autografting (only when indicated)

When indicated, conventional autografting in accordance with Investigator's standard practice

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2021-06-23
Completion
2022-06-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03626701 on ClinicalTrials.gov