NCT03722485终止不适用
Hydromechanical Cleansing With V.A.C. VERAFLO CLEANSE CHOICE™ Dressing and NPWTi-d vs. Collagenase Ointment in the Management of Full-thickness Wounds
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- KCI USA, Inc
- 入组人数
- 44
- 试验地点
- 10
- 主要终点
- Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal.
研究概览
简要总结
Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.
详细描述
This study evaluates changes in wound bed surface area of clean, healthy viable tissue in subjects with full-thickness wounds using negative pressure wound therapy with instillation of saline solution versus a collagenase ointment.
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
- •The Subject:
- •is anticipated to be hospitalized for the duration of treatment (minimum of 6 days).
- •is ≥ 18 years of age.
- •or their legally authorized representative is able to provide informed consent.
- •has been diagnosed with a wound (eg, chronic, acute, traumatic, or dehisced wounds) and/or ulcer (ie, full- thickness wounds) that meets the following criteria:
- •total surface area measuring ≥ 16 cm2, including a minimum width of 2 cm (before removal of eschar at the bedside and excluding undermining).
- •< 20 cm across (edge-to-edge) at any point perpendicular to the wound edges.
- •has, in the opinion of the investigator, no more than 2/3 of the wound bed surface area considered to be clean, healthy, and viable. If eschar is present at baseline, it must be removed by bedside debridement prior to assessing the percentage of clean, healthy, and viable wound bed.
- •has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) and is willing to take precautionary measures to prevent pregnancy during the duration of the study (up to 9 days).
排除标准
- •The Subject:
- •has been diagnosed with malignancy in the wound.
- •has untreated osteomyelitis.
- •has an untreated systemic infection.
- •has active cellulitis in the periwound area.
- •has a known allergy or hypersensitivity to study materials: collagenase ointment, dressing(s), and/or dressing components such as acrylic adhesives or polyurethane.
- •has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
- •has had radiation directly to the wound area.
- •has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history.
- •has eschar in the wound that cannot be removed by bedside sharp and/or mechanical debridement.
- •is participating in another interventional clinical trial for the duration of the study.
- •has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities.
- •has a wound with any tunneling present.
- •has inadequate hemostasis at the wound site, as determined by the investigator.
研究组 & 干预措施
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)
Experimental
V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
干预措施: Negative Pressure Therapy w/ instillation and dwell (NPWTi-d) (Device)
Collagenase Ointment
Active Comparator
Collagenase Ointment
干预措施: Collagenase Ointment (Biological)
结局指标
主要结局
Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal.
时间窗: baseline and 6-9 days of treatment
The Absolute Change in the Percentage of Wound bed surface area (cm2) considered to be clean, healthy, and viable from baseline to Day 6-9 upon the final dressing removal.
次要结局
- Physician Assessment of Need for Wound Debridement(6-9 days of treatment)
- Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.(baseline and 6-9 days of treatment)
- Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.(baseline and 6-9 days of treatment)
研究者
研究点 (10)
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