Perineal Tear and EpisiotomyARTHEMISNCT05888194
The Effect of Mucogyne® Gel on Wound Healing
A study testing Mucogyne® gel in people with Perineal Tear and Episiotomy, run by Biocodex at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perineal Tear and Episiotomy
- What is being tested?
- Mucogyne® gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 3 sitesFrance
- Study dates
- 12 Jun 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
CHU Lille
Lille, 59000
Isis CACHO, +33 3 20 44 59 62, isis.cacho@chu-lille.fr
- Recruiting
CHU Montpellier
Montpellier, 34000
Clémentine COMBES, +33 4 67 33 65 12, c-combes@chu-montpellier.fr
- Not yet recruiting
CHU Strasbourg
Strasbourg, 67200
About this study
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
- Being tested
- Mucogyne® gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mucogyne® gel |
| Control group | No intervention | Standard of care e.i no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 to Day 12 (+/-2) after delivery
Secondary outcomes (11)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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."
Measured: 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"
Measured: 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.
Measured: 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.
Measured: 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.)
Measured: Day 0 to Day 12 (+/-2) after delivery
To assess compliance with the Medical Device use
Number of days of use
Measured: 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.
Measured: Day 0 to Day 12 (+/-2) after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start12 Jun 2023
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal Tear and EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, prospective, randomized controlled study
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888194
- Sponsor's protocol ID
- MUCG-233
- Acronym
- ARTHEMIS
- Status last verified
- Mar 2024
- First submitted
- 22 May 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mucogyne® Gel on Wound Healing
- ClinicalTrials.gov ID
- NCT05888194
- Acronym / sponsor ID
- ARTHEMIS / MUCG-233
- Conditions
- Perineal Tear and Episiotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- BiocodexIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multicenter, prospective, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Mucogyne group | Experimental | Device: Mucogyne® gelIn 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. |
| Control group | No intervention | –Standard of care e.i no treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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,
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mucogyne® gelIn 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 group |
Primary outcome
To assess the effectiveness of topical application of Mucogyne® gel in postpartum perineal wound healing promotion.
Time frame: Day 0 to Day 12 (+/-2) after delivery
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.
11 secondary outcomes
To describe wound characteristics
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess pain relief (related to the vaginal wound)
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess the need/use of pain relieving drugs
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess change in clinical status
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess change in clinical status
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess the patient wound cosmetic appearance
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess the overall patient's satisfaction
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess re-appropriation and acceptance of the body by the patient
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess the patient perception of the Medical Device
Time frame: Day 0 to Day 12 (+/-2) after delivery
To assess compliance with the Medical Device use
Time frame: 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.
Time frame: Day 0 to Day 12 (+/-2) after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucogyne® gel in people with Perineal Tear and Episiotomy, run by Biocodex at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chloé GRZES (+33 3 44 86 75 94, c.grzes@biocodex.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effectiveness of topical application of Mucogyne® gel in postpartum perineal wound healing promotion. (time frame: Day 0 to Day 12 (+/-2) after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.