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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervicovaginitis

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaëlle MARIAULE; Phone Number: +33 3 44 86 75 97; Email: g.mariaule@biocodex.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To confirm the performance of Mucogyne® ovule in wound healing promotion	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.	Day 0 to day 21(+10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the aspect of the epithelium 3(+1) weeks after surgery	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)	Day 0 to day 21(+10)
To assess the performance of Mucogyne® ovule in symptoms relief	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	Day 0 to day 21(+10)
To assess the performance of Mucogyne® ovule in reducing postoperative side effects and complications	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.	Day 0 to day 21(+10)
To assess change in clinical status	Change in clinical status will be assessed by the Investigator using Clinical Global Impressions scale, (CGI) at 3(+1) weeks after surgery	Day 0 to day 21(+10)
To assess compliance with the Medical Device use	Compliance with the Medical Device use will be assessed by number of days of use	Day 0 to day 21(+10)
To assess the safety of Mucogyne® ovule	Number, nature and characteristics of any incident reported: incidence, seriousness, severity, resolution	Day 0 to day 21(+10)

Collaborators and Investigators

• Sponsor: Biocodex

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Estimated): September 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 3, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MUCO232

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No