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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Burn Wound

Intervention / Treatment
-----------------
* Device: Esterified Hyaluronic Acid Matrix


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esterified hyaluronic acid matrix<br> | Device: Esterified Hyaluronic Acid Matrix<br>* A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft |  | 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 |  | Baseline to 42 days | 
| Length of Stay in Inpatient Unit |  | Baseline to 42 days | 
| Patient Pain Rating |  | Baseline to 42 days | 
| Proportion of Split Thickness Skin Graft Take for the Wound at 28 Days |  | 28 days | 
| Proportion of Patients Who Develop an Infection of the Target Wound at Any Time Per Confirmation With Culture |  | Baseline to 70 days | 
| Subject Discharge Destination | The facility that the subject is discharged to will be captured. | Baseline to 70 days |