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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03723590
Other study ID # MED-2018-DIV31-006
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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