Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT06992960
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06992960
Study Brief:
Protocol Section:
NCT06992960