Study of SANTYL® vs Hydrogel (SoloSite®) for Pressure Ulcers
Condition: Pressure Ulcer
MeSH terms: Pressure Ulcer; Ulcer
Intervention: Santyl; SoloSite®
Intervention description: Collagenase ointment applied topically; SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pressure Ulcers; Bed sores; Long-term care; Nursing home

Summary:

      This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of
      pressure ulcers for participants in a long-term care facility. After meeting study criteria,
      participants will be randomly assigned for application of SANTYL® or SoloSite® to their
      pressure ulcer for up to 6 weeks. A study previously conducted showed that in the long-term
      care setting, the removal of dead skin (debridement) with SANTYL® resulted in more
      participants achieving complete debridement, more rapidly than when SoloSite® is used. The
      goal of the present study is to confirm the results of the earlier study, demonstrating
      superior debridement outcomes for pressure ulcers of patients in long-term care as compared
      to ulcers managed with SoloSite®.
    

Eligibility criteria:

        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.