Clinical trial NCT06585579: The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)
Official title: ORIGYNE (MUCO232) - the Effect of Mucogyne® Ovule on Wound Healing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervicovaginitis
Lead sponsor: Biocodex
Sponsor class: INDUSTRY
First posted: 2024-09-05
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, multicenter, randomized, controlled study
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To confirm the performance of Mucogyne® ovule in wound healing promotion
timeFrame: Day 0 to day 21(+10)
Secondary outcomes:
measure: To assess the aspect of the epithelium 3(+1) weeks after surgery
timeFrame: Day 0 to day 21(+10)
measure: To assess the performance of Mucogyne® ovule in symptoms relief
timeFrame: Day 0 to day 21(+10)
measure: To assess the performance of Mucogyne® ovule in reducing postoperative side effects and complications
timeFrame: Day 0 to day 21(+10)
measure: To assess change in clinical status
timeFrame: Day 0 to day 21(+10)
measure: To assess compliance with the Medical Device use
timeFrame: Day 0 to day 21(+10)
measure: To assess the safety of Mucogyne® ovule
timeFrame: Day 0 to day 21(+10)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Besançon
country: France
facility: CHU Besançon
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
affiliation: Chief Scientific Officer
name: Oana BERNARD, MD
role: STUDY_DIRECTOR
References: