The Effect of Mucogyne® Gel on Wound Healing | NCT05888194

NCT05888194

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

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:
- 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

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))
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