A Prospective, Randomised, Split-Body, Controlled, Non-Inferiority Clinical Study on the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Comparison of scar assessment at 12 months
研究概览
简要总结
Patients undergoing breast reduction or mastopexy surgery will be screened and recruited for participation in the study. Eligible patients will act as their own control with one breast receiving the active intervention (ChitoCare® medical Scar Healing Gel) and the other receiving standard of care (Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch). The active and control interventions will be applied for six months, and participants will be followed for up to 12 months. The scar properties of each breast will be assessed at study initiation (Day 0) and at study visits at 3, 6, 9, and 12 months using the Patient and Observer Scar Assessment Scale (POSAS) and via blinded assessment of photographs. Other subjective parameters such as pain, itching, and overall perception of the healed wound will be collected at each study visit via the POSAS, and patients' opinion, preferences, and compliance regarding the treatments will be collected via a basic questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the trial, both the participants and investigators will know which treatment is which, however, photographs of scars will be assessed by a blinded evaluator once all data collection is complete.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written informed consent must be given
- •Female ≥ 18 years old
- •Having planned or very recently (within 21 days) undergone breast reduction or mastopexy surgery on both breasts
- •Not yet begun any treatment aimed at reducing scarring
- •Wound is not infected at the time of enrolment
- •Able to understand and comply with the requirements of the study
排除标准
- •Patients with serious concomitant disease (cancer, heart failure (NYHA class IV), severe anaemia (Hb<100 g/L), neoplasia)
- •Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
- •Patients who will require additional surgical procedures during the study
- •Patients diagnosed with autoimmune connective tissue diseases
- •Previous treatment under this clinical protocol
- •Participation in another clinical trial
- •Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, is known to interfere with, or affect the rate and quality of wound healing
- •Allergy to shellfish* (if unknown, the patient may try a small sample of the IP on their intact skin to assess for any potential allergic reaction.)
- •Medical condition likely to require systemic corticosteroids during the study period
- •Pregnant or lactating women
结局指标
主要结局
Comparison of scar assessment at 12 months
时间窗: 12 months post-surgery
Comparison of the subjective assessment of scar appearance using the Patient and Observer Scar Assessment Scale 3.0 (POSAS) in active vs control group at 12-months post-surgery. The POSAS 3.0, for both the Patient Scale and the Observer Scale, rates each individual item on a 5-point scale. The minimum value for an item is 1, which corresponds to a scar characteristic or sensation that is like normal skin (a better outcome). The maximum value for an item is 5, which indicates the largest difference from normal skin or the worst imaginable scar characteristic or sensation (a worse outcome). The total score for the Patient Scale and the Observer Scale is calculated by summing the scores of the individual items within each scale. Consequently, for the POSAS 3.0, a higher total score on either the Patient Scale or the Observer Scale signifies a worse scar outcome or a greater severity of scar-related issues from that perspective.
次要结局
- Comparison of scar assessment at 3, 6, and 9 months(3, 6, and 9 months post-surgery)
- Improvement in subjective assessment of scar tissue(3, 6, 9, and 12 months post-surgery)
- Blinded assessment of scars(3, 6, 9, and 12 months post-surgery)
- Comparison of pain, discomfort, itching, and range of motion(3, 6, 9, and 12 months post-surgery)
- Adverse events(12 months post-surgery)
- Comparison of treatment compliance(6 months post-surgery)
- Cost comparison of treatments(6 months post-surgery)
- Patient treatment preference(3 and 6 months post-surgery)