Effect of Mucogyne® Gel on Healing of Perineal Wounds
The Effect of Mucogyne® Gel on Wound Healing
This study tests if Mucogyne® gel can help new moms heal better from perineal tears or cuts after childbirth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Biocodex Industry-sponsored |
| Locations | 3 sites (Lille and 2 other locations) |
| Trial ID | NCT05888194 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of Mucogyne® gel for wound healing in postpartum women with perineal tears or episiotomies. The study involves adult women who have experienced first or second-degree perineal injuries and will apply the gel according to its approved labeling. Participants will be monitored for their healing progress at designated hospital locations 12 days after childbirth. The study is designed to confirm the gel's effectiveness in promoting recovery from these specific types of wounds.
Who should consider this trial
Good fit: Ideal candidates are adult women with singleton pregnancies who have sustained first or second-degree perineal tears or episiotomies.
Not a fit: Patients with postpartum complications or those who develop complications during the study will not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could enhance wound healing and improve recovery experiences for postpartum women.
How similar studies have performed: While this approach is focused on a specific product, similar studies assessing topical treatments for wound healing have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille and 2 other locations
- CHU Lille — Lille, France (Recruiting)
- CHU Montpellier — Montpellier, France (Recruiting)
- CHU Strasbourg — Strasbourg, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Chloé GRZES
- Email: c.grzes@biocodex.fr
- Phone: +33 3 44 86 75 94
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.