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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
144
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)
CHU Amiens-Picardie
Amiens, France
CHU Besançon
Besançon, France
Hôpital Nord Franche-Comté
Trévenans, France
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)
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)
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)
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)
To assess change in clinical status
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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)
To assess compliance with the Medical Device use
Compliance with the Medical Device use will be assessed by number of days of use
Time frame: 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
Time frame: Day 0 to day 21(+10)