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NCT Number: NCT06585579

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

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.

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Key information

Conditions

Cervicovaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens-Picardie, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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),
  • Immunosuppressive treatment,
  • Heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent/day, according to the patient and their documented records),
  • Patients under judicial protection or under guardianship and patients deprived of freedom,
  • Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments.

Treatment and study plan

Mucogyne Ovule

Device

In Mucogyne group, patient will receive 2 boxes of Mucogyne® ovule. 24 hours after intervention, the patient will apply Mucogyne® ovule, 1 ovule per day for 10 days, to be repeated as needed (for practices' homogenisation, after the 10th day, it is recommended to apply one ovule every second day, until EOS visit)

Primary outcomes

  1. To confirm the performance of Mucogyne® ovule in wound healing promotion

    Time frame: 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 outcomes

  1. To assess the aspect of the epithelium 3(+1) weeks after surgery

    Time frame: 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)

  2. To assess the performance of Mucogyne® ovule in symptoms relief

    Time frame: 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

  3. To assess the performance of Mucogyne® ovule in reducing postoperative side effects and complications

    Time frame: 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.

  4. To assess change in clinical status

    Time frame: 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

  5. To assess compliance with the Medical Device use

    Time frame: Day 0 to day 21(+10)

    Compliance with the Medical Device use will be assessed by number of days of use

  6. To assess the safety of Mucogyne® ovule

    Time frame: Day 0 to day 21(+10)

    Number, nature and characteristics of any incident reported: incidence, seriousness, severity, resolution

Study contacts

Contact information is provided by the study sponsor or research team.

Gaëlle MARIAULE

CONTACT

[email protected]

+33 3 44 86 75 97

Sponsors and collaborators

Lead sponsor

Biocodex

Industry

Registry information

Official study title

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

Acronym: ORIGYNE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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