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

Primex

Status: Not yet enrolling

Conditions: Surgical Scars

Treatments: Device: ChitoCare® medical Scar Healing Gel (Örsáragel); Device: Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT06992960

CHITOSCAR-25-01

Details and patient eligibility

About

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.

Enrollment: 39 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Smoker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Active

Experimental group

Description:

ChitoCare® medical Scar Healing Gel (Örsáragel) administered topically twice daily for 6 months post-surgery

Treatment:

Device: ChitoCare® medical Scar Healing Gel (Örsáragel)

Control

Active Comparator group

Description:

Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch worn daily (continuous use, minimum 12 hrs per day as per the IFU) for 6 months post-surgery

Treatment:

Device: Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch