The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE) (NCT06585579) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)
France144 participantsStarted 2024-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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),
What they're measuring
1
To confirm the performance of Mucogyne® ovule in wound healing promotion