The Effect of Mucogyne® Gel on Wound Healing (ARTHEMIS)

Biocodex

Status: Enrolling

Conditions: Perineal Tear and Episiotomy

Treatments: Device: Mucogyne® gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05888194

MUCG-233

Details and patient eligibility

About

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.

Enrollment: 118 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Mucogyne group

Experimental group

Description:

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.

Treatment:

Device: Mucogyne® gel

Control group

No Intervention group

Description:

Standard of care e.i no treatment