Clinical trial NCT05888194: The Effect of Mucogyne® Gel on Wound Healing
Official title: The Effect of Mucogyne® Gel on Wound Healing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perineal Tear and Episiotomy
Lead sponsor: Biocodex
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, prospective, randomized controlled study
Primary purpose: OTHER

Brief summary: 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 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

Primary outcomes:
measure: To assess the effectiveness of topical application of Mucogyne® gel in postpartum perineal wound healing promotion.
timeFrame: Day 0 to Day 12 (+/-2) after delivery
Secondary outcomes:
measure: To describe wound characteristics
timeFrame: Day 0 to Day 12 (+/-2) after delivery
measure: To assess pain relief (related to the vaginal wound)
timeFrame: Day 0 to Day 12 (+/-2) after delivery
measure: To assess the need/use of pain relieving drugs
timeFrame: Day 0 to Day 12 (+/-2) after delivery
measure: To assess change in clinical status
timeFrame: Day 0 to Day 12 (+/-2) after delivery
measure: To assess change in clinical status
timeFrame: Day 0 to Day 12 (+/-2) after delivery
measure: To assess the patient wound cosmetic appearance
timeFrame: Day 0 to Day 12 (+/-2) after delivery
measure: To assess the overall patient's satisfaction
timeFrame: Day 0 to Day 12 (+/-2) after delivery
measure: To assess re-appropriation and acceptance of the body by the patient
timeFrame: Day 0 to Day 12 (+/-2) after delivery
measure: To assess the patient perception of the Medical Device
timeFrame: Day 0 to Day 12 (+/-2) after delivery
measure: To assess compliance with the Medical Device use
timeFrame: Day 0 to Day 12 (+/-2) after delivery
measure: To assess the safety of Mucogyne® gel : Number, nature and characteristics of any incident reported: incidence, seriousness, severity, resolution.
timeFrame: Day 0 to Day 12 (+/-2) after delivery
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU Lille
city: Montpellier
country: France
facility: CHU Montpellier
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
References: