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

Burn Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03723590
• Other study ID #: MED-2018-DIV31-006
• Status: Terminated
• Phase: N/A
• Start date: February 6, 2019
• Est. completion date: September 22, 2021

Study information

• Verified date: November 2021
• Source: Medline Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 22, 2021
• Est. primary completion date: September 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Wound
• Burns

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medline Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Length of Stay in Inpatient Unit		Baseline to 42 days
Secondary	Patient Pain Rating		Baseline to 42 days
Secondary	Proportion of Split Thickness Skin Graft Take for the Wound at 28 Days		28 days
Secondary	Proportion of Patients Who Develop an Infection of the Target Wound at Any Time Per Confirmation With Culture		Baseline to 70 days
Secondary	Subject Discharge Destination	The facility that the subject is discharged to will be captured.	Baseline to 70 days