Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT05888194
Eligibility Criteria:
Inclusion Criteria:
1. Adult women with singleton pregnancy
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:
1. Postpartum complications, or developed early bleeding after delivery
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05888194
Study Brief:
Protocol Section:
NCT05888194