The Effect of Mucogyne® Gel on Wound Healing

Biocodex118 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

118

Conditions

Perineal Tear and Episiotomy

Interventions

Mucogyne® gelDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

CHU Lille

Lille, France

RECRUITING

CHU Montpellier

Montpellier, France

RECRUITING

CHU Strasbourg

Strasbourg, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

To describe wound characteristics

Wound characteristics will be described using the Redness, Oedema, Ecchymosis, Discharge, Approximation (REEDA) scale sub-score at each visit. 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.

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

To assess pain relief (related to the vaginal wound)

The presence of perineal pain (related to the vaginal wound) at rest, in movement, while sitting, while urinating and defecating

Central Contacts

Chloé GRZES

CONTACT

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

Data from ClinicalTrials.gov

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