To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing With Respect to Wound Exudate Management, Wound Healing Progression and Peri Wound Skin Condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to Wound Healing progression.
研究概览
简要总结
To demonstrate the safety and performance of both AMS ActivHeal Silicone Foam and AMS ActivHeal Silicone Foam Lite dressings to both the patient and clinician in managing both chronic and acute wounds.
详细描述
This PMCF study has been set up to investigate and assess residual risks in relation to the CE-marked AMS ActivHeal Silicone Foam and Silicone Foam Lite dressing . The purpose of this study is primarily to collect clinical follow-up data on the AMS ActivHeal Silicone Foam and Silicone Foam Lite dressing , as CE-marking was based on equivalence. The data and conclusions obtained from this study will be used to provide clinical evidence of safety and effectiveness for the clinical evaluation process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should be using contraception).
- •Subjects who are able to understand and give informed consent to take part in the evaluation.
- •No local or systemic signs of infection, including new pain or increasing pain, erythema, local warmth, swelling, purulent discharge, pyrexia (in surgical wounds, typically five to seven days after surgery), delayed wound healing, abscess or malodour.
- •None to high levels of exudate
排除标准
- •Patients who decline the invitation to take part.
- •Patients who are known to be non-compliant with medical treatment,
- •Patients who are known to be sensitive to any of the dressing components.
- •Broken/ damaged or prone to blistering peri wound skin.
- •Presence of a clinically infected wound as determined by the presence of three or more of the following clinical signs: peri wound, erythema, pain between dressing changes, malodourous wound, abundant exudate, oedema, abscess, cellulitis, purulent discharge, discolouration, friable granulation tissue which bleeds easily.
- •Patients who have a current illness or condition which may interfere with wound healing in the last 30 days which may interfere with wound healing (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse.)
- •Life expectancy of <6 months.
结局指标
主要结局
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to Wound Healing progression.
时间窗: After each dressing change up to 6 weeks following application of dressing
Success will be determined by no deterioration of the wound. The assessor will assess the wound size and the % tissue types within the wound.
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the per wound skin conditions.
时间窗: After each dressing change up to 6 weeks following application of dressing
Success will be determined by no deterioration of peri wound skin. The peri wound skin will be assessed for maceration and signs of inflammation. A relative score will be used to score maceration of zero (no maceration), one (minimal maceration), two (moderate maceration), and three (excessive maceration and need to withdraw patient from study). Success will be determined that over the evaluation an increased score would represent peri wound deterioration. This will be measured using VAS value (0= no erythema, redness and skin erosion and 10 = extensive erythema, redness and skin erosion).
Primary 1 Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of wound exudate.
时间窗: After each dressing change up to 6 weeks following application of dressing
Success will be determined by no deterioration of the wound or peri wound skin. A relative score will be used to score maceration of zero (no maceration), one (minimal maceration), two (moderate maceration), and three (excessive maceration and need to withdraw patient from study.
次要结局
- Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to ease of use of the dressing.(After each dressing change up to 6 weeks following application of dressing)
- Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to conformability of the dressing.(After each dressing change up to 6 weeks following application of dressing)
- Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to dressing contours to anatomical contours of major wound site.(After each dressing change up to 6 weeks following application of dressing)
- Effectiveness of dressing removal of both the Silicone Foam and Silicone Lite dressing will assessed.(After each dressing change up to 6 weeks following application of dressing)
- Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to overall acceptability of the dressing.(After each dressing change up to 6 weeks following application of dressing)
- Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of exudate.(After each dressing change up to 6 weeks following application of dressing.)
- Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to peri wound skin condition.(After each dressing change up to 6 weeks following application of dressing.)
- Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to wound pain.(After each dressing change up to 6 weeks following application of dressing)
- Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to wound healing progression.(After each dressing change up to 6 weeks following application of dressing.)