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

Not Applicable

Not yet recruiting

• Conditions: Cervicovaginitis
• Interventions: Device: Mucogyne Ovule

• Registration Number: NCT06585579
• Lead Sponsor: Biocodex

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-03
• Last Update Submitted: 2024-09-03
• Study First Posted: 2024-09-05
• Last Update Posted: 2024-09-05
• Study Start: 2024-10
• Primary Completion: 2025-08
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mucogyne group	Mucogyne Ovule	For each eligible patient, the study will consist of: * A Screening/Inclusion visit * A treatment period (application of the medical device Mucogyne® ovule) for 21 days * An End Of Study visit (Day 21 (+10) after surgery)

Primary Outcome Measures

Name	Time	Method
To confirm the performance of Mucogyne® ovule in wound healing promotion	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.

Secondary Outcome Measures

Name	Time	Method
To assess the aspect of the epithelium 3(+1) weeks after surgery	Day 0 to day 21(+10)	Criteria assessing the aspect of the epithelium (such as presence of mucosa, stroma, presence and quality of mucus, opening of the cervix, presence or absence of inflammation, edema, vulvo-vaginal abrasions, coalescence, adherence, leucorrhoea and bleeding at contact)
To assess the performance of Mucogyne® ovule in symptoms relief	Day 0 to day 21(+10)	Vaginal symptoms (dryness, itching, burning, discharge) will be assessed by the patient using a 4-point scale (1 = absent, 2 = mild, 3 = moderate, 4 = severe) at 3 (+1) weeks after surgery
To assess the performance of Mucogyne® ovule in reducing postoperative side effects and complications	Day 0 to day 21(+10)	Postoperative side-effects (i.e. postoperative bleeding, infection and impairment of daily activities, etc.) will be assessed using a questionnaire. For the assessment of hemorrhage, the amounts of bleeding will be checked with a pictorial blood assessment chart.
To assess change in clinical status	Day 0 to day 21(+10)	Change in clinical status will be assessed by the Investigator using Clinical Global Impressions scale, (CGI) at 3(+1) weeks after surgery
To assess compliance with the Medical Device use	Day 0 to day 21(+10)	Compliance with the Medical Device use will be assessed by number of days of use
To assess the safety of Mucogyne® ovule	Day 0 to day 21(+10)	Number, nature and characteristics of any incident reported: incidence, seriousness, severity, resolution

Trial Locations

Locations (3)

CHU Amiens-Picardie; 🇫🇷 Amiens, France

CHU Besançon; 🇫🇷 Besançon, France

Hôpital Nord Franche-Comté; 🇫🇷 Trévenans, France