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

Smith & Nephew

Status and phase: Terminated; Phase 4

Conditions: Pressure Ulcer

Treatments: Biological: Santyl; Biological: SoloSite®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02718625

017-101-09-036

Details and patient eligibility

About

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®.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Santyl

Experimental group

Description:

Santyl collagenase ointment applied topically once per day for up to six weeks

Treatment:

Biological: Santyl

SoloSite®

Active Comparator group

Description:

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.

Treatment:

Biological: SoloSite®