The Effect of Mucogyne® Gel on Wound Healing
试验速览
- 阶段
- 不适用
- 发起方
- Biocodex
- 入组人数
- 118
- 试验地点
- 6
- 主要终点
- To assess the effectiveness of topical application of Mucogyne® gel in postpartum perineal wound healing promotion.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control group
Standard of care e.i no treatment
Mucogyne 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.
干预措施: Mucogyne® gel (Device)
结局指标
主要结局
To assess the effectiveness of topical application of Mucogyne® gel in postpartum perineal wound healing promotion.
时间窗: 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.
次要结局
- 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 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)
- To assess re-appropriation and acceptance of the body by the patient(Day 0 to Day 12 (+/-2) after delivery)
- To assess the patient perception of the Medical Device(Day 0 to Day 12 (+/-2) after delivery)
- To describe wound characteristics(Day 0 to Day 12 (+/-2) after delivery)
- To assess the patient wound cosmetic appearance(Day 0 to Day 12 (+/-2) after delivery)
- To assess the overall patient's satisfaction(Day 0 to Day 12 (+/-2) after delivery)
- To assess compliance with the Medical Device use(Day 0 to Day 12 (+/-2) after delivery)
- To assess change in clinical status(Day 0 to Day 12 (+/-2) after delivery)