Clinical trial NCT03723590: A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG
Official title: A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix on Preparing Wounds in Burn Patients for Split-thickness Skin Grafting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burn Wound
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2018-10-29
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft
timeFrame: Baseline to 42 days
Secondary outcomes:
measure: 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
timeFrame: Baseline to 42 days
measure: Length of Stay in Inpatient Unit
timeFrame: Baseline to 42 days
measure: Patient Pain Rating
timeFrame: Baseline to 42 days
measure: Proportion of Split Thickness Skin Graft Take for the Wound at 28 Days
timeFrame: 28 days
measure: Proportion of Patients Who Develop an Infection of the Target Wound at Any Time Per Confirmation With Culture
timeFrame: Baseline to 70 days
measure: Subject Discharge Destination
timeFrame: Baseline to 70 days
Other outcomes:
Locations:
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