Multicenter, Randomised in Parallel Groups, Controlled Study to Compare Performance and Safety of Suprasorb®X+PHMB Pro With Suprasorb® X+PHMB Dressing in Treatment of Infected Venous Leg Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Rate and severity of maceration after 3 weeks of treatment with Suprasorb®X+PHMB (Pro)
研究概览
简要总结
This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.
详细描述
During the screening, all patients will be assessed for inclusion and exclusion criteria and wound exudation status. Eligible patients with slight or moderate wound exudation will be randomly assigned to treatment with either Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB. The patients who fulfil all other eligibility criteria but have high level of wound exudation will enter a 7-days run-in period, during which they will receive superabsorbent dressing (e.g. Vliwazell® Pro, Vliwasorb® Pro) and monitored compression therapy with Rosidal® 1C. During the run-in period they should receive appropriate treatment including systemic antimicrobial drug therapy if required. After this time, these patients should be re-assessed and in case they still fulfil all eligibility criteria, and the exudation decreased at least to a moderate level, they will be randomised to Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB. In case the exudation would not decrease within this period or other eligibility criteria are not met anymore, they will be screened out.
Upon randomisation, all patients will receive the assigned dressing for 21 (±2) days, or till the complete epithelialization, if it occurs earlier. The patients should also continue to receive adequate compression and, if necessary, systemic antimicrobial drug therapy. During the study participation, selected parameters of the wound will be assessed at Baseline, Interim Visit, and EOT visit. In addition, dressing changes may be performed in-between on as needed basis. After 3 weeks of treatment with Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB, all patients will complete the study. Their further treatment (if necessary), will not be the part of the study.
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
- Single (Outcomes Assessor)
盲法说明
Primary endpoint ans some secondary endpoints will be re-confirmed by a blinded assessment of the wound photographs
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
- •Age ≥ 18 years
- •Infected* venous** leg ulcer
- •Slightly to moderately exuding wound***
- •Patient has signed informed consent
- •as per CDC definition, also TILI score ≥ 5 ** ABPI > 0.8 and < 1.2 *** patients with highly exuding wounds may be screened for a 7 days run-in period to receive superabsorbent dressing and monitored compression therapy and re-con-sidered for enrolment in case the exudation level decreases
排除标准
- •Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomisation and during the whole duration of this study
- •Wounds with exposed cartilage tissue (hyaline cartilage)
- •Contraindications to compression therapy (e.g.: advanced peripheral ar-terial occlusive diseases, decompensated cardiac insufficiency, septic phlebitis, phlegmasia coerulea dolens, sensation disorders of the skin)
- •Known allergy and/or hypersensitivity to any components of the study product or concomitant products (e.g. compression bandage)
- •Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and / or interpreta-tion of the study results.
结局指标
主要结局
Rate and severity of maceration after 3 weeks of treatment with Suprasorb®X+PHMB (Pro)
时间窗: 3 weeks
on a 4-grade scale there 0 means no maceration and 4 means severe maceration
次要结局
- Wound area change over time(3 weeks)
- Change of necrotic & fibrinous & granulation tissue rate in the wound bed(3 weeks)
- Change of wound infection status(3 weeks)
- Product safety (rate of product-related complications)(3 weeks)
- Change of wound exudation and presence of peri-wound oedema(3 weeks)
- Change in patient's pain(3 weeks)
- Product usability(3 weeks)
- Change in patient's quality of life(3 weeks)
- Oedema chamge(3 weeks)
- Sub-bandage pressure levels retention(3 weeks)