The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)
ConditionCervicovaginitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBiocodex
About this trial
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
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Mucogyne Ovule
DeviceIn 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)
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Mucogyne groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 0 to day 21(+10)Secondary outcomes
1
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)
Time frame
Day 0 to day 21(+10)2
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
Time frame
Day 0 to day 21(+10)3
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.
Time frame
Day 0 to day 21(+10)4
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
Time frame
Day 0 to day 21(+10) Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: