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.
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differential appearance of the treated and untreated (placebo) scars at 24 weeks, using the global scar comparison scale assessed by a blinded adjudication committee composed of 3 experts.
Timeframe: Up to 24 weeks (the primary endpoint will be judged at 24 weeks)