A Prospective, Randomized, Controlled Study Using Cross-Over Design to Evaluate and Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- % of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21
研究概览
简要总结
A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.
详细描述
The study will be conducted in an outpatient setting of an academic clinical center over a total period of four weeks (28 days, -1/+2).
The aim of this RCT is to evaluate and compare three different foam dressings in the local management of chronic wounds (i.e. venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs)) in an outpatient setting. A bordered, five-layer, flexible foam dressing with soft silicone adhesive technology will be evaluated versus a hydropolymer, adhesive foam island dressing and a multi-layered, hydrocellular foam dressing with silicone adhesive, within three focus areas; efficacy and safety of the dressings, participant-centric outcomes and health economic evaluation.
Note: The terms used within the body of this report and results, in both the Primary and Secondary Outcomes, are defined as follows:
Period 1: Weeks 1 and 2 of study follow-up visits. Period 2: Weeks 3 and 4 of study follow-up visits. Week 1: Designates data captured only on visit days 7 and 21. Week 2: Designates data captured only on visit days 14 and 28. During Week 1: Designates data captured on visit days 3, 7, 17 and 21. During Week 2: Designates data captured on visit days 10, 14, 24 and 28. Day 3 of Week 1 from tables: inclusive of data captured on Visit Days 3 and 17. Day 3 of Week 2 from tables: inclusive of data captured on Visit Days 10 and 24.
Day 7 of Week 1 from tables: inclusive of data captured on Visit Days 7 and 21. Day 7 of Week 2 from tables: inclusive of data captured on Visit Days 14 and 28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU).
- •Signed informed consent.
- •Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear.
- •Study subject must be available and able to visit the clinic weekly for the full 4-week period.
排除标准
- •Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
- •Presence of local wound infection as determined by study doctor based on clinical signs and symptoms.
- •Subject has any evidence of peripheral arterial disease (PAD).
- •Subject diagnosed with malignancy other than cutaneous basal cell carcinoma.
- •Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix e.g. amnion, amniotic tissue) within 2 weeks of screening date.
- •Pregnancy or lactation at time of study participation.
- •Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
- •Subject is currently enrolled or participated in another investigational device, drug or biological trial within 30 days of baseline of this study.
- •Present history of alcohol or drug abuse.
- •Known allergy/hypersensitivity to any of the components of the dressing.
- •Subject not suitable for the investigation according to the investigator's judgment.
结局指标
主要结局
% of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21
时间窗: Weeks 1 and 3
Intact dressing after 7 days wear time, assessed @ Wk1 Day7 \& Wk3 Day21 only. 1st week of dressing wear (Wks 1 \& 3) is critical for start of wound healing. Contributing factors to strike-through: Saturation of dressing pad: * Inappropriate dressing type * Inappropriate dressing change freq. (i.e. more frequent changes required) * Change in wound condition (e.g. increase in exudate amt) Dislodgement of dressing: * Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation) * Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility) * Patient interference w/ dressing Dressing design deficiency: * Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission) * Insufficient adhesion * Insufficient conformability (i.e. ability to conform to body contours \& challenging anatomical wound locations)
% of Participants With Equal or Better Rate of Dressing Durability
时间窗: 4 weeks
Dressing strike-through determined @ Wk1 Day 3\&7, and Wk3 Day 17\&21. Dressing strike-through that occurred Day 3 and/or 7, Day 17 and/or 21 were included in final dataset. Contributing factors to strike-through: Saturation of dressing pad: * Inappropriate dressing type * Inappropriate dressing change freq. (i.e. more frequent changes required) * Change in wound condition (e.g. increase in exudate amt) Dislodgement of dressing: * Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation) * Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility) * Patient interference w/ dressing Dressing design deficiency: * Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission) * Insufficient adhesion * Insufficient conformability (i.e. ability to conform to body contours \& challenging anatomical wound locations)
次要结局
- % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation(4 weeks)
- % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both)(4 weeks)
- Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire(4 weeks)
- % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer(4 weeks)
- % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer(4 weeks)
- % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer(4 weeks)
- % of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings(4 weeks)