Evaluation of the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPrimex ehf

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

Treatment groups

39 Participants
are divided into 2 treatment groups

Sponsors and collaborators