The Effect of Mucogyne® Gel on Wound Healing

NCT05888194 | Recruiting DMC

• 1 other identifier: MUCG-233
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 3

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.

Conditions

Perineal Tear and Episiotomy

Outcome Measures

Primary Outcomes (1)

• To assess the effectiveness of topical application of Mucogyne® gel in postpartum perineal wound healing promotion.

  Wound healing will be assessed using the perineal healing scale after episiotomy or perineal tear, the Redness, Oedema, Ecchymosis, Discharge, Approximation (REEDA) scale, change between baseline (48h postpartum) and 12 days postpartum days (after 10 days of application of Mucogyne® gel) will be calculated.The REEDA scale is an observational check list used for assessing perineal wound healing that was primarily developed by Davidson (1974). It can be used to assess all types of postpartum perineal trauma. It has five components namely Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges. Each component takes a score ranged from 0 to 3. Total REEDA score ranges between 0 and 15. Higher score indicates poor wound healing while lower score indicates good wound healing. The total score of REEDA scale was categorized as follows; Completely healed from 0 to 2, Moderately healed from 3 to 5, Mildly healed from 6 to 8, and Not healed from 9 to 15.

  Day 0 to Day 12 (+/-2) after delivery

Secondary Outcomes (11)

• To describe wound characteristics

  Day 0 to Day 12 (+/-2) after delivery

• To assess pain relief (related to the vaginal wound)

  Day 0 to Day 12 (+/-2) after delivery

• To assess the need/use of pain relieving drugs

  Day 0 to Day 12 (+/-2) after delivery

• To assess change in clinical status

  Day 0 to Day 12 (+/-2) after delivery

• To assess change in clinical status

  Day 0 to Day 12 (+/-2) after delivery

Study Arms (2)

Mucogyne group

EXPERIMENTAL

In Mucogyne group, each eligible patient will receive a box of Mucogyne® gel. The patient will apply Mucogyne® gel, 48-hours after delivery, everyday, twice a day, massaging it into the intimate area, for a 10-day period.

Device: Mucogyne® gel

Control group

NO INTERVENTION

Standard of care e.i no treatment

Interventions

Mucogyne® gel DEVICE

In Mucogyne group, each eligible patient will receive a box of Mucogyne® gel. The patient will apply Mucogyne® gel, 48-hours after delivery, everyday, twice a day, massaging it into the intimate area, for a 10-day period.

Mucogyne group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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
• Affiliated to the Social Security system

You may not qualify if:

• Postpartum complications, or developed early bleeding after delivery
• Third and fourth degree perineal tear.
• 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))
• 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)
• Immunosuppressive treatment.
• Heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent/day, according to the mothers and their documented records),
• Patients under legal protection or under guardianship and patients deprived of freedom
• Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments

Sponsors & Collaborators

• Biocodex: lead

Study Sites (3)

CHU Lille

Lille, 59000, France

RECRUITING

CHU Montpellier

Montpellier, 34000, France

RECRUITING

CHU Strasbourg

Strasbourg, 67200, France

NOT YET RECRUITING

Central Study Contacts

Chloé GRZES

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicenter, prospective, randomized controlled study

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 5, 2023
• Study Start: June 12, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)