The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)
This study is investigating a product called Mucogyne Ovule, which is a gel insert. It's designed to help women heal after certain minor surgeries on their cervix or vagina, such as those for abnormal cell changes. The main goal of this research is to see if Mucogyne Ovule is safe and works well to help the healing process, just as expected. Researchers will follow women who have had these types of operations and are using the ovule, to make sure it performs as intended and doesn't cause any unexpected problems. This is a follow-up study on a product already available, aiming to confirm its effectiveness in real-world use.
At a glance
What is this study about?
Imagine you've had a small procedure on your cervix or vagina, perhaps to remove some abnormal cells. Your doctor might suggest something to help you heal afterwards. This study is focusing on a product called Mucogyne Ovule, which is a gel insert designed to do just that – help the healing process. It's already available, but this study is a way for researchers to carefully watch and check if it's working as it should and if it’s safe when used by women after these types of surgeries. They want to make sure it really does support the natural healing of the area.
The main idea is to confirm that Mucogyne Ovule performs as expected in helping the body recover. By carefully observing women who are using it after these procedures, the researchers can gather more information about its effects. This helps ensure that the product is a good and helpful option for women going through these surgeries. It's all about gathering more evidence to be sure about its benefits and safety for patients.
This type of study is important because it helps doctors and patients understand how treatments work in real-life situations. The goal is to provide reassurance that Mucogyne Ovule is an effective part of the healing journey after certain local surgeries, helping women to recover comfortably and safely.
Key takeaways
- This study evaluates Mucogyne Ovule for healing after minor cervical/vaginal surgery.
- It aims to confirm the product's safety and effectiveness.
- Participation involves using the ovule and attending follow-up appointments.
- You must be an adult woman who recently had a specific type of surgery.
- There are important health and medication rules for joining.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult woman who has recently had a minor surgery on your cervix or vagina, such as a laser treatment or a LEEP conization, to remove abnormal cells. You also need to be able to understand what the study involves and agree to take part by signing a consent form. It's important that you don't have any other serious health issues that might affect how your body heals or how the study results are measured.
There are also some reasons why you might not be able to join. For example, if you've had similar vaginal surgery in the past year, or if you're allergic to any of the ingredients in Mucogyne Ovule. You also couldn't join if you have an infection in the area that needs healing, or if you regularly take certain medications like anti-inflammatory drugs or blood thinners. Conditions that affect healing, like severe diabetes or an ongoing illness, would also mean you couldn't take part. They also ask that you don't smoke heavily and aren't involved in any other vaginal product studies at the same time.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an adult woman (18 years or older)?
- Have you recently had minor surgery on your cervix or vagina (like laser or LEEP for abnormal cells)?
- Have you NOT had other vaginal surgery in the last year?
- Do you NOT have any known allergies to ingredients in Mucogyne Ovule?
- Are you NOT taking certain regular medications like blood thinners or strong anti-inflammatories?
- Do you NOT have other serious health problems that affect healing (e.g., severe diabetes, immune conditions)?
What does participation involve?
If you decide to take part, you would be using Mucogyne Ovule as directed by your doctor after your surgery. You would need to attend appointments where the study team can check on your healing and make sure everything is progressing well. They would likely ask you questions about how you're feeling and might examine the treated area. You'd need to agree not to use any other vaginal products during your time in the study, apart from those specifically allowed by the study plan. The full duration of your participation, including follow-up, would be explained to you by the study team.
Potential risks and benefits
Locations (3)
- CHU Amiens-PicardieVerified postcodeAmiens, France
- CHU BesançonVerified postcodeBesançon, France
- Hôpital Nord Franche-ComtéVerified postcodeTrévenans, France
Common questions
What is Mucogyne Ovule?
It's a gel insert designed to help the healing process after certain minor surgeries on the cervix or vagina.
Who can join this study?
Adult women who have had specific minor surgeries on their cervix or vagina and meet other health criteria.
What kind of surgery is this study for?
It's for minor surgeries like laser treatment or LEEP conization on the cervix or vagina, often for abnormal cells.
Will I have to pay to be in the study?
No, clinical studies do not usually charge participants, and your social security system coverage is a requirement for participation.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without it affecting your regular medical care.
How to find out more
Gaëlle MARIAULE
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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