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

Study Overview
=================
Brief 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®.

Official Title
-----------------
A Randomized Controlled Trial of Enzymatic Debridement of Pressure Ulcers With Clostridial Collagenase Ointment (SANTYL®) or Hydrogel (SoloSite®)

Conditions
-----------------
Pressure Ulcer

Intervention / Treatment
-----------------
* Biological: Santyl
* Biological: SoloSite®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - 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. Eighteen (18) years of age or older, of either sex, and of any race. Willing to comply with protocol instructions, including allowing all study assessments. Subject is in-patient in a long-term care facility. 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). The target ulcer must present with ≥85% necrotic, nonviable tissue as assessed by two independent image reviewers. 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. 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). 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. 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. Have adequate pressure redistribution to the affected area or off-loading if the ulcer is on a lower extremity. 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 - Undergoing therapy with another investigational agent within thirty (30) days of Study Visit 1, or planned participation overlapping with this study. Current oral steroid treatment with a daily dose exceeding 5 mg. Inability to comply with off-loading. 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. Presence of callus requiring surgical debridement within 3 days of Study Visit 1. Target ulcer with exposure of tendon, muscle or bone. Medical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Santyl<br>Santyl collagenase ointment applied topically once per day for up to six weeks | Biological: Santyl<br>* Collagenase ointment applied topically<br>|
| Active Comparator: SoloSite®<br>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. | Biological: SoloSite®<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Ulcers With Complete Debridement | For purposes of the primary analysis, the status of complete debridement was to be assessed from photographs by two independent reviewers. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Days to Complete Debridement | For purposes of this secondary analysis, the time (in days) to achieve complete debridement (as defined in the primary analysis) was to be calculated from the date of randomization visit to the date of which the subject's ulcer was deemed to have achieved complete debridement. | 6 weeks | 
| Percentage Reduction in Non-viable Tissue | For purposes of this secondary analysis, the assessment of percentage of non-viable necrotic tissue was to be assessed based on photograph review by two independent reviewers, with the reduction calculated as: percentage of non-viable necrotic tissue at Visit 1 - percentage of non-viable necrotic tissue at Visit 7. | 6 weeks | 
| Percentage Reduction in Ulcer Area | For purposes of this secondary analysis, the percentage reduction in ulcer area was to be measured during ulcer photograph review by two independent reviewers, using the ImageIQ EDCIQ mobile imaging system, with the reduction calculated as: ([ulcer area at Visit 1 - ulcer area at Visit 7 / ulcer area at Visit 1] x 100). | 6 weeks | 
| Pressure Ulcer Scale for Healing (PUSH) Score | For purposes of this secondary analysis, changes in wound status were to be measured by using the Pressure Ulcer Scale for Healing (PUSH) Tool. At Visits 1 and 7, the target ulcer was to be scored based on length/width (from 0 cm^2 to >24 cm^2 on a scale of 1 to 10), exudate amount (from 'none' to 'heavy' on a scale of 0 to 3) , and tissue type ('closed' to 'necrotic tissue' on a scale of 0 to 4); from which a total PUSH score from the sum of scores for the three categories could be derived (ranging from 0 to 17). Higher scores indicated a worse response. The reduction in PUSH individual sub-scores and total PUSH scores were calculated as: (PUSH Score at Visit 1 - Push Score at Visit 7/Exit). | 6 weeks | 
| Wound Bed Sore (WBS) Score | For purposes of this secondary analysis, changes in wound status were to be measured by using the Wound Bed Sore (WBS) score. At Visits 1 and 7, eight individual wound bed sore characteristics were scored, each on a scale of 0 to 2 (higher scores represented better outcomes), and then summed to derive the total WBS score (ranging from 0 to 16). The reduction in total WBS scores were calculated as: (Total WBS Score at Visit 1 - Total WBS Score at Visit 7/Exit). | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pressure Ulcers, Bed sores, Long-term care, Nursing home