Back to resultsA Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG
Primary Purpose
Burn Wound
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Esterified Hyaluronic Acid Matrix
Sponsored by
About this trial
This is an interventional treatment trial for Burn Wound
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Esterified hyaluronic acid matrix
Arm Description
Outcomes
Primary Outcome Measures
Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft
Secondary Outcome Measures
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
Length of Stay in Inpatient Unit
Patient Pain Rating
Proportion of Split Thickness Skin Graft Take for the Wound at 28 Days
Proportion of Patients Who Develop an Infection of the Target Wound at Any Time Per Confirmation With Culture
Subject Discharge Destination
The facility that the subject is discharged to will be captured.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03723590
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
September 22, 2021 (Actual)
Study Completion Date
September 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medline Industries
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esterified hyaluronic acid matrix
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Esterified Hyaluronic Acid Matrix
Intervention Description
A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss
Primary Outcome Measure Information:
Title
Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft
Time Frame
Baseline to 42 days
Secondary Outcome Measure Information:
Title
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
Time Frame
Baseline to 42 days
Title
Length of Stay in Inpatient Unit
Time Frame
Baseline to 42 days
Title
Patient Pain Rating
Time Frame
Baseline to 42 days
Title
Proportion of Split Thickness Skin Graft Take for the Wound at 28 Days
Time Frame
28 days
Title
Proportion of Patients Who Develop an Infection of the Target Wound at Any Time Per Confirmation With Culture
Time Frame
Baseline to 70 days
Title
Subject Discharge Destination
Description
The facility that the subject is discharged to will be captured.
Time Frame
Baseline to 70 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG
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