Clinical trial NCT06992960: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgical Scars
Lead sponsor: Primex ehf
Sponsor class: INDUSTRY
First posted: 2025-05-28
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Comparison of scar assessment at 12 months
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Comparison of scar assessment at 3, 6, and 9 months
timeFrame: 3, 6, and 9 months post-surgery
measure: Improvement in subjective assessment of scar tissue
timeFrame: 3, 6, 9, and 12 months post-surgery
measure: Blinded assessment of scars
timeFrame: 3, 6, 9, and 12 months post-surgery
measure: Comparison of pain, discomfort, itching, and range of motion
timeFrame: 3, 6, 9, and 12 months post-surgery
measure: Adverse events
timeFrame: 12 months post-surgery
measure: Comparison of treatment compliance
timeFrame: 6 months post-surgery
measure: Cost comparison of treatments
timeFrame: 6 months post-surgery
measure: Patient treatment preference
timeFrame: 3 and 6 months post-surgery
Other outcomes:
Locations:
city: Reykjavík
country: Iceland
facility: Klíníkin Ármúla
state: Höfuðborgarsvæðið
Study officials:
References: