Post-surgical Scars After the Use of CACIPLIQ20

Launched by ORGAN, TISSUE, REGENERATION, REPAIR AND REPLACEMENT · Sep 2, 2022

Keywords

ClinConnect Summary

The MATRISCAR study is a clinical trial that is examining the effects of a medical device called CACIPLIQ20 on healing scars after breast reduction surgery. Scars can form after any surgery or injury, and while they usually improve over time, some can be raised, painful, or unsightly. This trial aims to see if applying CACIPLIQ20 right after surgery can help improve the quality of scars and reduce symptoms like pain and swelling.

To participate in this study, women aged 18 to 85 who are scheduled for a specific type of breast reduction surgery may be eligible. Participants will receive detailed information about the study and must agree to be followed for the duration of the trial. Importantly, women who are pregnant, breastfeeding, or have certain health issues may not qualify. If you join the trial, you can expect to receive either the treatment or a placebo (a non-active substance) to compare results. The goal is to confirm earlier findings that CACIPLIQ20 can significantly improve scar healing.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients scheduled for bilateral breast reduction (\>300 g by breast) using the conventional superior pedicle technique with inverted-T scars
• • 2. Age between 18 and 85 years
• • 3. Patients having received a full written and oral information about study conduct and objectives
• • 4. Patients who can and are willing to be followed by the study investigator for the duration of the study
• • 5. Patients benefiting from a valid health insurance or social security coverage
• Exclusion Criteria:
• • 1. Female patients who are pregnant, or lactating
• • 2. Patients with, according to investigator's opinion, a very poor life expectancy
• • 3. Patients intolerant to one of the study device components or to heparinoids
• • 4. Any scar treatment other than the standard of care
• • 5. Previous breast surgery
• • 6. Current malignancy