A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 2/14/2019 |
| Start Date: | February 6, 2019 |
| End Date: | May 2020 |
| Contact: | Stephanie Martynenko, BS |
| Email: | smartynenko@medline.com |
| Phone: | 224-216-3822 |
A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix on Preparing Wounds in Burn Patients for Split-thickness Skin Grafting
Burn patients meeting inclusion criteria will receive the esterified hyaluronic acid matrix
as the primary matrix to manage 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, the patient's
physician determines an STSG is no longer necessary or 42 days of use with the wound matrix
occur. 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.
as the primary matrix to manage 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, the patient's
physician determines an STSG is no longer necessary or 42 days of use with the wound matrix
occur. 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.
Inclusion Criteria:
- Has a wound originating from a thermal burn
- Target burn has total burn surface area between 0.5%-20%
- Patient has undergone escharectomy procedure on burn site 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
Exclusion Criteria:
- Current active diagnosis of substance abuse
- Patient currently taking non-inhaled corticosteroids
- Patient needs or is likely to need negative pressure wound therapy
- Patient is pregnant, planning to become pregnant during study period, or breastfeeding
- Unstable medical condition as determined by the site investigator
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