Overview
The aim of this post-market clinical follow up study is to confirm the efficacy and safety of topical application of Mucogyne® gel in the process of wound healing, when used in accordance with its approved labeling, in the context of postpartum perineal wounds.
Eligibility
Inclusion Criteria:
- Adult women with singleton pregnancy
- Have a perineal tear or mediolateral episiotomy
- 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
- 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,
- Is able to comply with protocol requirements and respect the conditions of the study,
- Accept to come to the mentioned hospital 12(+/-2) days after childbirth
- Affiliated to the Social Security system
Exclusion Criteria:
- Postpartum complications, or developed early bleeding after delivery
- Third and fourth degree perineal tear.
- Previous vaginal/perineal surgery within the year preceding the inclusion in the study
- Had undergone extended episiotomy (incision size > 3 - 4 cm)
- Anal fissures.
- Known hypersensitivity to any of the medical device ingredients
- With local infectious lesions in the area to be repaired.
- Who use drugs known to disturb wound healing (example : anticoagulants during pregnancy (based on self-reports))
- 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)
- Immunosuppressive treatment.
- Heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent/day, according to the mothers and their documented records),
- Patients under legal 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