About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ChitoCare® medical Scar Healing Gel (Örsáragel)
- Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch