UnknownNot Applicable

The Effect of Mucogyne® Gel on Wound Healing

France118 participantsStarted 2023-06-12

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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:
✓. 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

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))

What they're measuring

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

Trial details

NCT IDNCT05888194

SponsorBiocodex

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05

Contact for this trial

Chloé GRZES

+33 3 44 86 75 94 c.grzes@biocodex.fr

View on ClinicalTrials.gov More Perineal Tear and Episiotomy trials