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RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years

NCT03624192 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-07-18

Study results available
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Summary

To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only). The mean time for donor site healing will be compared between treatments.

Conditions

  • Skin; Deformity

Interventions

DEVICE

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

OTHER

Telfa™ Clear and Xeroform™ dressings

Telfa™ Clear and Xeroform™ dressings

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2020-01-13
Completion
2020-01-13
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03624192 on ClinicalTrials.gov