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

NCT03723590 | Terminated Results FDA Device

• 1 other identifier: MED-2018-DIV31-006
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Burn Wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Esterified hyaluronic acid matrix

EXPERIMENTAL

Device: Esterified Hyaluronic Acid Matrix

Interventions

Esterified Hyaluronic Acid Matrix DEVICE

A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss

Esterified hyaluronic acid matrix

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medline Industries: lead

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

Due to a business decision with the pandemic it was decided to terminate this study and data was never collected from the site or analyzed for this study.

Results Point of Contact

• Title: Julie Miller
• Organization: Medline Industries

jamiller@medline.com

630-418-6891

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 29, 2018
• Study Start: February 6, 2019
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: September 6, 2023
• Results First Posted: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP