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

Not Applicable

Terminated

• Conditions: Burn Wound
• Interventions: Device: Esterified Hyaluronic Acid Matrix

• Registration Number: NCT03723590
• Lead Sponsor: Medline Industries

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-26
• Study First Posted: 2018-10-29
• Study Start: 2019-02-06
• Primary Completion: 2021-09-22
• Study Completion: 2021-09-22
• Status Verified: 2021-11
• Results First Submitted: 2021-11-02
• Results First Submitted QC: 2021-11-02
• Results First Posted: 2021-12-01
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Esterified hyaluronic acid matrix	Esterified Hyaluronic Acid Matrix	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Patient Pain Rating	Baseline to 42 days
Length of Stay in Inpatient Unit	Baseline to 42 days
Subject Discharge Destination	Baseline to 70 days	The facility that the subject is discharged to will be captured.
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
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