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

Medline Industries

Status: Terminated

Conditions: Burn Wound

Treatments: Device: Esterified Hyaluronic Acid Matrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT03723590

MED-2018-DIV31-006

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Esterified hyaluronic acid matrix

Experimental group

Treatment:

Device: Esterified Hyaluronic Acid Matrix