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A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG

NCT03723590 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-09-06

Study results available
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Summary

Burn patients meeting inclusion criteria will receive the esterified hyaluronic acid matrix as the matrix for their wound, in conjunction with the standard of care for managing these types of wounds. The study will be divided into two phases. Phase I will entail intervention with the wound matrix and will continue until one of the following occur, sufficient granulation has occurred and the patient can receive a STSG and proceed to Phase II, the patient's physician determines an STSG is no longer necessary or two applications with the wound matrix occur and no STSG is approved. Phase II will begin following the STSG procedure. In this phase, the wound will be monitored and proportion of STSG take will be evaluated but no application of the wound matrix device will take place. This phase will continue for 28 days or if the physician deems the patient no longer needs regular care to monitor the wound, whichever occurs earlier.

Conditions

  • Burn Wound

Interventions

DEVICE

Esterified Hyaluronic Acid Matrix

A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss

Sponsors & Collaborators

  • Medline Industries

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2021-09-22
Completion
2021-09-22
FDA Device
Yes

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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 NCT03723590 on ClinicalTrials.gov