Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
118 participants
INTERVENTIONAL
2023-06-12
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Mucogyne group
In Mucogyne group, each eligible patient will receive a box of Mucogyne® gel. The patient will apply Mucogyne® gel, 48-hours after delivery, everyday, twice a day, massaging it into the intimate area, for a 10-day period.
Mucogyne® gel
In Mucogyne group, each eligible patient will receive a box of Mucogyne® gel. The patient will apply Mucogyne® gel, 48-hours after delivery, everyday, twice a day, massaging it into the intimate area, for a 10-day period.
Control group
Standard of care e.i no treatment
No interventions assigned to this group
Interventions
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Mucogyne® gel
In Mucogyne group, each eligible patient will receive a box of Mucogyne® gel. The patient will apply Mucogyne® gel, 48-hours after delivery, everyday, twice a day, massaging it into the intimate area, for a 10-day period.
Eligibility Criteria
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Inclusion Criteria
2. Have a perineal tear or mediolateral episiotomy
3. First (with cutaneous injury) and 2nd-degree perineal tear/episiotomy, whose length and depth are as the following:
* depth (from the fourchette into the greatest depth of the perineal body) ≤3cm,
* length of vaginal mucosa (from the fourchette to the apex of the vaginal tear) ≤4cm
* length of skin (from the fourchette along perineal skin towards the anus) ≤3cm
4. Is able to understand the study related information and to give a written informed consent,
5. Has signed the informed consent form before beginning any study procedure,
6. Has no condition that may interfere with the study assessments,
7. Is able to comply with protocol requirements and respect the conditions of the study,
8. Accept to come to the mentioned hospital 12(+/-2) days after childbirth
9. Affiliated to the Social Security system
Exclusion Criteria
2. Third and fourth degree perineal tear.
3. Previous vaginal/perineal surgery within the year preceding the inclusion in the study
4. Had undergone extended episiotomy (incision size \> 3 - 4 cm)
5. Anal fissures.
6. Known hypersensitivity to any of the medical device ingredients
7. With local infectious lesions in the area to be repaired.
8. Who use drugs known to disturb wound healing (example : anticoagulants during pregnancy (based on self-reports))
9. Had a history of diseases known to disturb wound healing (e.g. systemic, heart, and renal diseases, coagulation disorders, immune deficiency, connective tissue disorders, diabetes, anemia (with hemoglobin level \< 9 g/dl) and hemophilia)
10. Immunosuppressive treatment.
11. Heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent/day, according to the mothers and their documented records),
12. Patients under legal protection or under guardianship and patients deprived of freedom
13. Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments
18 Years
FEMALE
No
Sponsors
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Biocodex
INDUSTRY
Responsible Party
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Locations
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CHU Lille
Lille, , France
CHU Montpellier
Montpellier, , France
CHU Strasbourg
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MUCG-233
Identifier Type: -
Identifier Source: org_study_id
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