A Randomized Controlled Trial of Enzymatic Debridement of Pressure Ulcers With Clostridial Collagenase Ointment (SANTYL®) or Hydrogel (SoloSite®)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Proportion of Ulcers With Complete Debridement
研究概览
简要总结
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®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •Presence of callus requiring surgical debridement within 3 days of Study Visit
- •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.
研究组 & 干预措施
SoloSite®
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.
干预措施: SoloSite® (Biological)
Santyl
Santyl collagenase ointment applied topically once per day for up to six weeks
干预措施: Santyl (Biological)
结局指标
主要结局
Proportion of Ulcers With Complete Debridement
时间窗: 6 weeks
For purposes of the primary analysis, the status of complete debridement was to be assessed from photographs by two independent reviewers.
次要结局
- Time in Days to Complete Debridement(6 weeks)
- Percentage Reduction in Ulcer Area(6 weeks)
- Pressure Ulcer Scale for Healing (PUSH) Score(6 weeks)
- Wound Bed Sore (WBS) Score(6 weeks)
- Percentage Reduction in Non-viable Tissue(6 weeks)