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

Official title

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)

Overview

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.

Interventions

• Device ChitoCare® medical Scar Healing Gel (Örsáragel)
  ChitoCare® medical Scar Healing Gel is a topical gel indicated for the treatment of new and old scars. The Scar Healing Gel provides a soothing effect and support to the scar tissue to heal in an orderly manner. It protects against infections, stimulates cell proliferation in old and new scars, as well as correct tissue organization with proper collagen alignment for a better aesthetic appearance and skin flexibility. Ideal for treating scars after accidents, surgery, C-section and cosmetic surg
• Device Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch
  Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch are silicon-based, single-patient, multi-use scar patches intended for use as scar reduction therapy in surgical breast scars. The silicone creates a moist environment on the scar, which prevents the scar from drying out. It keeps the scar soft and has a positive effect on scar tissue. The devices are specifically designed for breast scarring and are shaped to fit the normal surgical scars experi

Primary outcome measures

• Comparison of scar assessment at 12 months [Time frame: 12 months post-surgery]

Secondary outcome measures (8)

• Comparison of scar assessment at 3, 6, and 9 months [Time frame: 3, 6, and 9 months post-surgery]
• Improvement in subjective assessment of scar tissue [Time frame: 3, 6, 9, and 12 months post-surgery]
• Blinded assessment of scars [Time frame: 3, 6, 9, and 12 months post-surgery]
• Comparison of pain, discomfort, itching, and range of motion [Time frame: 3, 6, 9, and 12 months post-surgery]
• Adverse events [Time frame: 12 months post-surgery]
• Comparison of treatment compliance [Time frame: 6 months post-surgery]
• Cost comparison of treatments [Time frame: 6 months post-surgery]
• Patient treatment preference [Time frame: 3 and 6 months post-surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Iceland · 1 center

• Klíníkin Ármúla — Reykjavik

Identifiers

NCT: NCT06992960 · CHITOSCAR-25-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗