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

Launched by PRIMEX EHF · May 19, 2025

Keywords

ClinConnect Summary

The CHITOSCAR trial is studying how well a special gel called ChitoCare® helps heal scars in women who are having breast reduction or lifting surgery (mastopexy). In this trial, each participant will use the gel on one breast while the other breast will have a standard silicone patch for comparison. Both treatments will be applied for six months, and the researchers will follow up with the participants for up to a year to see how well the scars heal. They will look at things like the appearance of the scars, any pain or itching, and how the women feel about their healing process.

To join the study, women must be at least 18 years old, have recently had surgery on both breasts, and not started any other scar treatments yet. They also need to be healthy enough to participate and not have any serious medical conditions that could affect the study. Throughout the trial, participants will provide feedback on their experience and any side effects they may have. This study is not yet recruiting participants, but it aims to help improve scar healing after breast surgery.

Gender

FEMALE

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