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NCT04589442 · ClinicalTrials.gov registry record · Phase 4

Microsurfaced Grafts in Deep Burn Wounds

A Phase 4 study of Burns and Wound Heal, sponsored by CellTherX.

Recruiting
Registry status
Phase 4
Development phase
20
Enrollment target
1
Study location

NCT04589442 is a Phase 4 study of Burns and Wound Heal that is actively recruiting participants, run by CellTherX. The registered enrollment target is 20 participants, below the 83-participant average among 36 other Burns trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04589442, a Phase 4 study of Burns and Wound Heal, is actively recruiting participants, sponsored by CellTherX.

RECRUITING
Registry status
Phase 4
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. This study will be performed in 2 parts: Time to wound bed preparedness through 6 weeks (Part A) and wound site healing, graft take and long-term scar outcomes (Part B). Subjects will be treated with both control and microsurfaced cadaveric grafts on adjacent deep-partial or full-thickness burn wounds.

Conditions Studied

Interventions

  • BIOLOGICAL Split thickness skin graft
  • BIOLOGICAL microsurfaced split thickness skin graft

Study Locations (1)

Georgia

  • Joseph M Still Research Foundation - Augusta

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-01-04
Est. Completion 2021-12
Phase Phase 4

Sponsor

CellTherX

1 total trials

What the Registry Record Tells You About NCT04589442

The ClinicalTrials.gov registry entry for NCT04589442 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 36 other Burns trials with a reported enrollment target (76% lower). The listed sponsor is CellTherX, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Burns appearing as the primary indexed condition, and to 2 interventions - of which Split thickness skin graft is the first listed.

NCT04589442 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT04589442 about?

NCT04589442 is a clinical study titled "Microsurfaced Grafts in Deep Burn Wounds". This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. This study will be performed in 2 parts: Time to...

What is the current status of trial NCT04589442?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2021-01-04. Estimated completion is 2021-12.

What conditions does trial NCT04589442 study?

This clinical trial studies the following conditions: Burns, Wound Heal.

What interventions are being tested in trial NCT04589442?

The interventions under investigation include: Split thickness skin graft (BIOLOGICAL), microsurfaced split thickness skin graft (BIOLOGICAL).

Who is sponsoring clinical trial NCT04589442?

This trial is sponsored by CellTherX, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04589442 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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