Status:
NOT_YET_RECRUITING
Evaluation of the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)
Lead Sponsor:
Primex ehf
Conditions:
Surgical Scars
Eligibility:
FEMALE
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06992960
Start Date
September 1 2025
End Date
October 1 2026
Last Update
August 14 2025
Active Locations (1)
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1
Klíníkin Ármúla
Reykjavik, Capital Region, Iceland, 108