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COMPLETED NA

A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries

NCT01138917 · View on ClinicalTrials.gov ↗

Study Summary

This is a randomized, within-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined as recipient site wound closure at week 4 follow-up visit of the ReCell-treated area as compared to that of the STMSG-treated area, and 2)superiority in the healing of the ReCell donor site as compared to the STMSG donor site at week 1.

Conditions Studied

Interventions

  • DEVICE ReCell and Split-thickness skin graft

Study Locations (12)

Florida

  • Shands Burn Center at University of Florida — Gainesville
  • Tampa General Hospital — Tampa

North Carolina

  • NC Jaycee Burn Center at University of NC at Chapel Hill — Chapel Hill
  • Wake Forest University Health Sciences — Winston-Salem

Texas

  • USAISR — Fort Sam Houston
  • Texas Tech University Health Sciences Center — Lubbock

Arizona

  • Arizona Burn Center at Maricopa Integrated Health Systems — Phoenix

California

  • University of California Davis Regional Burn Center — Sacramento

District of Columbia

  • The Burn Center at Washington Hospital Center — Washington D.C.

Indiana

  • Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital — Indianapolis

Tennessee

  • University of Tennessee Medical Center — Memphis

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2010-05-21
Est. Completion 2015-08-26
Phase NA

Sponsor

Avita Medical

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01138917

The ClinicalTrials.gov registry entry for NCT01138917 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avita Medical, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Burns appearing as the primary indexed condition, and to 1 intervention — of which ReCell and Split-thickness skin graft is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01138917 reports 12 study locations spanning 9 distinct geographic areas — top geographies include Florida, North Carolina, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01138917 about?

NCT01138917 is a clinical study titled "A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries". This is a randomized, within-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined a...

What is the current status of trial NCT01138917?

This trial is currently completed. It is a NA study. The enrollment target is 101 participants. The study started on 2010-05-21. Estimated completion is 2015-08-26.

What conditions does trial NCT01138917 study?

This clinical trial studies the following conditions: Burns. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01138917?

The interventions under investigation include: ReCell and Split-thickness skin graft (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01138917?

This trial is sponsored by Avita Medical, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01138917 being conducted?

This trial has 12 study locations across Arizona, California, District of Columbia, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial