Overview

Post-surgical Scars After the Use of CACIPLIQ20

Status:
Not yet recruiting

Trial end date:
2023-10-01

Target enrollment:
0

Participant gender:
Female

Summary

Following surgical procedures or injury, cutaneous scars can develop due to production of collagen-rich connective tissue. These scars may be accompanied by redness, itching, pain, and restricted mobility of the skin. Typically, after a few weeks, the scar matures, becoming lighter and narrower, although full maturation of a scar may take up to 2 years. In some cases, however, cutaneous scars can be unsightly or can even become hyper- trophic or result in keloids. Preventing pathological scarring is much easier than treating scars later and should be started as early as possible after the injury or surgery. CACIPLIQ20® is a medical device used for the treatment of chronic skin ulcers, and contains a molecule belonging to the family of ReGeneraTing Agents (RGTA®). RGTA®s are biodegradable polymers that mimic the action of heparan sulfates found in the extracellular matrix of injured tissues. RGTA® accelerates tissue healing in various animal models, by stabilizing and protecting heparin-binding growth factors (HBGFs) and matrix proteins. In addition to its effects on hard-to-heal chronic wounds, CACIPLIQ20® was found to improve acute wound healing in pre-clinical models and in several case reports and controlled clinical studies. A first open label-controlled study showed that the topical application of RGTA® improved skin healing in mammoplasty patients and notably reduced oedema and pain in patients who had undergone centrofacial lift surgery compared to untreated patients. Results from this first study were confirmed in a double-blind placebo self-controlled trial conducted in two medical institutions in China involving 71 patients. The Chinese study showed that a single application of CACIPLIQ20® significantly improved scar healing quality at 14 days as well as scar symptoms including pain, swelling and exudate. The aim of the MATRISCAR study is to confirm the previous results in a double-blind, placebo-controlled randomized clinical trial.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Organ, Tissue, Regeneration, Repair and Replacement

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