Post-marketing Surveillance of a Flexible Wound Dressing for the Management of Genital Skin Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- gynaecological skin condition
研究概览
简要总结
The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Diagnosed genital skin condition
排除标准
- •Unable to give informed consent
- •Patient unable to apply topical device
- •Allergy or intolerance to ingredients or excipients of the formulation of studied products
研究组 & 干预措施
Treatment arm
Film forming silicone gel (7-0940) is an innovative gel that forms a full contact, flexible wound dressing for supporting mucosal conditions of the genital, rectal and perineal areas.
Film forming silicone gel (7-0940) is a semi-occlusive, non-resorbable, self-drying and transparent gel.
Film forming silicone gel (7-0940) may be directly applied to dry, wet, cracked and sensitive mucosal tissue.
Film forming silicone gel (7-0940) gel is bacteriostatic and inert. It contains no alcohols, parabens or fragrances.
干预措施: Film forming silicone gel (7-0940) (Device)
结局指标
主要结局
gynaecological skin condition
时间窗: Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months
Likert scales to measure: * Dryness * Tissue thinning * Erosion/Ulcers * Fissures * Erythema * Scarring/adhesion * Contact bleeding * Bloodblisters * Greyish film * White lacy streaks
次要结局
- patient symptoms(Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months)