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 range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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