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

August 11, 2023 updated by: Medline Industries

A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix on Preparing Wounds in Burn Patients for Split-thickness Skin Grafting

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has a wound originating from a thermal or electrical burn
  • Target burn area is less than 20% of TBSA
  • Target burn wound is greater than 0.5% of TBSA
  • Patient has undergone escharectomy procedure or will undergo escharectomy on the target burn and resulting wound will likely need a split thickness skin graft, but wound site is not immediately ready for grafting
  • For patients with diabetes, an A1C hemoglobin level between 11 percent (taken within 90 days)

Exclusion Criteria:

  • Current active diagnosis of substance abuse, per the Investigator
  • Patient currently taking non-inhaled corticosteroids
  • Patient needs or is likely to need negative pressure wound therapy of the target wound after application of Hyalomatrix Wound Device
  • Patient is pregnant, planning to become pregnant during study period, or breastfeeding
  • Unstable medical condition as determined by the site investigator
  • Patients with known sensitivities to hyaluronan, hyaluronan derivatives, silicone, or any other ingredients of the Hyalomatrix Wound Device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Esterified hyaluronic acid matrix
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft
Time Frame: Baseline to 42 days
Baseline to 42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Wound Volume From the Time Prior to Application of the Wound Device to the Time Before the Application of STSG and After STSG
Time Frame: Baseline to 42 days
Baseline to 42 days
Length of Stay in Inpatient Unit
Time Frame: Baseline to 42 days
Baseline to 42 days
Patient Pain Rating
Time Frame: Baseline to 42 days
Baseline to 42 days
Proportion of Split Thickness Skin Graft Take for the Wound at 28 Days
Time Frame: 28 days
28 days
Proportion of Patients Who Develop an Infection of the Target Wound at Any Time Per Confirmation With Culture
Time Frame: Baseline to 70 days
Baseline to 70 days
Subject Discharge Destination
Time Frame: Baseline to 70 days
The facility that the subject is discharged to will be captured.
Baseline to 70 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medline Industries

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2019

Primary Completion (Actual)

September 22, 2021

Study Completion (Actual)

September 22, 2021

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

October 26, 2018

First Posted (Actual)

October 29, 2018

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-2018-DIV31-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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