ORIGYNE (MUCO232) - the Effect of Mucogyne® Ovule on Wound Healing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Biocodex
- 入组人数
- 144
- 试验地点
- 6
- 主要终点
- To confirm the performance of Mucogyne® ovule in wound healing promotion
研究概览
简要总结
This clinical investigation is a post-market clinical follow-up performed to confirm the performance and safety of the Mucogyne® ovule medical device in promoting the process of wound healing, when used in accordance with its approved labelling, in the context of local cervicovaginal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women who had undergone localized surgery (laser or loop electrosurgical excision procedure (LEEP) conization) for cervical or vaginal dysplasia,
- •Is able to understand the study related information and to give a written informed consent,
- •Has signed the informed consent form before beginning any study procedure,
- •Has no condition that may interfere with the study assessments,
- •Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,
- •Is able to comply with protocol requirements and respect the conditions of the study,
- •Affiliated to the Social Security system.
排除标准
- •Previous vaginal surgery within the year preceding the inclusion in the study,
- •Known hypersensitivity to any of the medical device ingredients,
- •Patient with local infectious lesions in the area to be repaired.
- •Patient who had used anti-inflammatory drugs (regular intake) or anticoagulants during the month preceding the inclusion in the study,
- •Patient who had a history of diseases known to disturb wound healing (e.g. systemic, heart, and renal diseases, coagulation disorders, immunedeficiency, connective tissue disorders, diabetes, anemia (with hemoglobin level < 9 g/dl) and hemophilia),
- •Immunosuppressive treatment,
- •Heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent/day, according to the patient and their documented records),
- •Patients under judicial protection or under guardianship and patients deprived of freedom,
- •Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments.
结局指标
主要结局
To confirm the performance of Mucogyne® ovule in wound healing promotion
时间窗: Day 0 to day 21(+10)
The primary endpoint is a composite endpoint derived with the following criteria: * Inflammation evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed, * Edema evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed, * Abrasion evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed, * Coalescence evaluated with a 3-point scale (none, partial, total) and not assessed. * Opening of the cervix (only for cervical wound) evaluated with a 4-point scale (closed, slightly open, open, gaping) and not assessed.
次要结局
- To assess the aspect of the epithelium 3(+1) weeks after surgery(Day 0 to day 21(+10))
- To assess the performance of Mucogyne® ovule in symptoms relief(Day 0 to day 21(+10))
- To assess the performance of Mucogyne® ovule in reducing postoperative side effects and complications(Day 0 to day 21(+10))
- To assess change in clinical status(Day 0 to day 21(+10))
- To assess compliance with the Medical Device use(Day 0 to day 21(+10))
- To assess the safety of Mucogyne® ovule(Day 0 to day 21(+10))