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

Biocodex

Status: Not yet enrolling

Conditions: Cervicovaginitis

Study type: Interventional

Funder types: Industry

Identifiers

NCT06585579

MUCO232

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult women who had undergone localized surgery (laser or loop electrosurgical excision procedure (LEEP) conization) for cervical or vaginal dysplasia,
2. Is able to understand the study related information and to give a written informed consent,
3. Has signed the informed consent form before beginning any study procedure,
4. Has no condition that may interfere with the study assessments,
5. Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,
6. Is able to comply with protocol requirements and respect the conditions of the study,
7. Affiliated to the Social Security system.

Exclusion criteria

1. Previous vaginal surgery within the year preceding the inclusion in the study,
2. Known hypersensitivity to any of the medical device ingredients,
3. Patient with local infectious lesions in the area to be repaired.
4. Patient who had used anti-inflammatory drugs (regular intake) or anticoagulants during the month preceding the inclusion in the study,
5. 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),
6. Immunosuppressive treatment,
7. Heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent/day, according to the patient and their documented records),
8. Patients under judicial protection or under guardianship and patients deprived of freedom,
9. Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)