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Clinical Trial NCT05888194 (ARTHEMIS) for Perineal Tear and Episiotomy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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The Effect of Mucogyne® Gel on Wound Healing (ARTHEMIS)

Recruiting
Clinical Trial NCT05888194 (ARTHEMIS) is an interventional study for Perineal Tear and Episiotomy that is recruiting. It started on 12 June 2023 with plans to enroll 118 participants. Led by Biocodex, it is expected to complete by 1 May 2024. The latest data from ClinicalTrials.gov was last updated on 12 March 2024.
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.
Official Title

The Effect of Mucogyne® Gel on Wound Healing

Conditions
Perineal Tear and Episiotomy
Other Study IDs
  • ARTHEMIS
  • MUCG-233
NCT ID Number
NCT05888194
Start Date (Actual)
2023-06-12
Last Update Posted
2024-03-12
Completion Date (Estimated)
2024-05
Enrollment (Estimated)
118
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalMucogyne group
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® Gel
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.
No InterventionControl group
Standard of care e.i no treatment
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 Outcome Measures
Outcome MeasureMeasure DescriptionTime 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.
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
Day 0 to Day 12 (+/-2) after delivery
To assess the need/use of pain relieving drugs
Number of used pain-relieving drug related to the vaginal wound healing
Day 0 to Day 12 (+/-2) after delivery
To assess change in clinical status
Change in clinical status will be assessed by Clinical Global Impressions scale, (CGI-I). The CGI was developed for use in clinical trials to provide a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.
Day 0 to Day 12 (+/-2) after delivery
To assess change in clinical status
Change in clinical status will be assessed by Patients' Global Impression of Change scale (PGIC). The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Day 0 to Day 12 (+/-2) after delivery
To assess the patient wound cosmetic appearance
Wound cosmetic appearance will be assessed using a scale from the "worst scar" to the "best scar"
Day 0 to Day 12 (+/-2) after delivery
To assess the overall patient's satisfaction
Patient satisfaction will be assessed using Patient Satisfaction Score (PSS) rated based on scores of 0 to 10, with higher scores indicating better satisfaction and lower scores indicating poorer satisfaction.
Day 0 to Day 12 (+/-2) after delivery
To assess re-appropriation and acceptance of the body by the patient
Re-appropriation and acceptance of the body will be assessed by a questionnaire. The body reappropriation scale is composed of 5 questions in 7 points with 1="Strongly agree" and 7="Strongly disagree". This scale looks at the patient's ability to look at her scar in a mirror, to clean it, to touch it and to massage it. One question concerns the impact of the scar's appearance on the patient's self-esteem.
Day 0 to Day 12 (+/-2) after delivery
To assess the patient perception of the Medical Device
A customized questionnaire about sensory analysis of the study product (texture, ease of spreading, softness after application, aqueous, freshness, etc.)
Day 0 to Day 12 (+/-2) after delivery
To assess compliance with the Medical Device use
Number of days of use
Day 0 to Day 12 (+/-2) after delivery
To assess the safety of Mucogyne® gel : Number, nature and characteristics of any incident reported: incidence, seriousness, severity, resolution.
Day 0 to Day 12 (+/-2) after delivery
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female

  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

  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
Biocodex logoBiocodex
Study Central Contact
Contact: Chloé GRZES, +33 3 44 86 75 94, [email protected]
3 Study Locations in 1 Countries
CHU Lille, Lille, 59000, France
Isis CACHO, Contact, +33 3 20 44 59 62, [email protected]
Recruiting
CHU Montpellier, Montpellier, 34000, France
Clémentine COMBES, Contact, +33 4 67 33 65 12, [email protected]
Recruiting
CHU Strasbourg, Strasbourg, 67200, France
Not yet recruiting