The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)

Официальное название

ORIGYNE (MUCO232) - the Effect of Mucogyne® Ovule on Wound Healing

Обзор

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.

Вмешательства

• Устройство Mucogyne Ovule
  In Mucogyne group, patient will receive 2 boxes of Mucogyne® ovule. 24 hours after intervention, the patient will apply Mucogyne® ovule, 1 ovule per day for 10 days, to be repeated as needed (for practices' homogenisation, after the 10th day, it is recommended to apply one ovule every second day, until EOS visit)

Первичные конечные точки

• To confirm the performance of Mucogyne® ovule in wound healing promotion [Срок оценки: Day 0 to day 21(+10)]

Вторичные конечные точки (6)

• To assess the aspect of the epithelium 3(+1) weeks after surgery [Срок оценки: Day 0 to day 21(+10)]
• To assess the performance of Mucogyne® ovule in symptoms relief [Срок оценки: Day 0 to day 21(+10)]
• To assess the performance of Mucogyne® ovule in reducing postoperative side effects and complications [Срок оценки: Day 0 to day 21(+10)]
• To assess change in clinical status [Срок оценки: Day 0 to day 21(+10)]
• To assess compliance with the Medical Device use [Срок оценки: Day 0 to day 21(+10)]
• To assess the safety of Mucogyne® ovule [Срок оценки: Day 0 to day 21(+10)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 3 центра

• CHU Amiens-Picardie — Amiens
• CHU Besançon — Besançon
• Hôpital Nord Franche-Comté — Trévenans

Идентификаторы

NCT: NCT06585579 · MUCO232 · 2022-A02640-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗