Study of SANTYL® vs Hydrogel (SoloSite®) for Pressure Ulcers

This is an interventional treatment trial for Pressure Ulcer focused on measuring Pressure Ulcers, Bed sores, Long-term care, Nursing home Read More

Inclusion Criteria -

1. Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.
2. Eighteen (18) years of age or older, of either sex, and of any race.
3. Willing to comply with protocol instructions, including allowing all study assessments.
4. Subject is in-patient in a long-term care facility.
5. A pressure ulcer present with a surface area ≥ 1.0 cm2 and ≤ 64.0 cm2 confirmed using the ImageIQ EDCIQ mobile imaging system. Only one qualifying ulcer per subject will be selected for the study (selection based on greatest clinical need, as assessed by the Investigator).
6. The target ulcer must present with ≥85% necrotic, nonviable tissue as assessed by two independent image reviewers.
7. The target ulcer has not been previously treated with hydrogel (SoloSite®) or with SANTYL®. Prior ulcers at or near the same location may have been treated with these products.
8. No current infections requiring treatment with antibiotics (antibiotic use is permitted for the purpose of urinary tract infection prophylaxis, but this must be explicitly stated in the subject's chart).
9. Acceptable state of health and nutrition with pre-albumin levels of ≥ 10 mg/dL (0.10 g/L), per the Screening local lab report. This is not required if a pre-albumin test within range has been conducted within the last 30 days.
10. A hemoglobin A1c < 7.9% per the Screening local lab report. This is not required if a hemoglobin A1c test within range has been conducted within the last 30 days.
11. Have adequate pressure redistribution to the affected area or off-loading if the ulcer is on a lower extremity.
12. No known allergies or sensitivities to either test article or the dressings.

Women of child-bearing potential (those who are not premenarchal, not surgically sterilized [hysterectomy or bilateral oophorectomy], or not post-menopausal), may participate in the study if they meet the following condition:

-A negative urine pregnancy test at screening

Exclusion Criteria -

1. Undergoing therapy with another investigational agent within thirty (30) days of Study Visit 1, or planned participation overlapping with this study.
2. Current oral steroid treatment with a daily dose exceeding 5 mg.
3. Inability to comply with off-loading.
4. If the ulcer is on a lower extremity, inadequate arterial blood flow to the affected limb as evidenced by an ankle brachial index (ABI) <0.85.
5. Presence of callus requiring surgical debridement within 3 days of Study Visit 1.
6. Target ulcer with exposure of tendon, muscle or bone.
7. Medical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.