Gastritis is an inflammation of the gastric mucosa. In this study, we investigated the efficacy of a medical device, Esoxx®, basedon hyaluronic acid and chondroitin sulfate on gastritis-related upper abdominal pain/discomfort and endoscopic features. Fiftypatients, affected by gastritis, were randomised to receive the medical device or placebo. The primary endpoint was the medicaldevice efficacy on upper abdominal pain/discomfort associated with gastritis and measured byVisual Analogue Scale (VAS). Thesecondary endpoints were the efficacy of the medical device on gastritis-related mucosal erosions, blood oozing, and hyperemia(redness)/edema, as assessed by endoscopy, and the patients’ rating of their compliance with the treatments. A significantreduction in VAS pain was observed in the treatment group after a 5-week treatment, if compared with placebo (p < 0.001). Insummary, administration of a medical device, based on hyaluronic acid and chondroitin sulfate, improves gastritis-related upperabdominal pain/discomfort and decreases mucosal erosions, blood oozing, and hyperemia (redness)/edema at 5-week follow-upin patients affected by gastritis.
Objective: Long-term bedridden patients are at high risk of acquring pressure ulcers (PUs). In this group of patients, prevention is necessaryto cut the health costs, improve quality of life and reduce the mortality. Here, we evaluated the effectiveness of a cross-linked hyaluronic acid(HA) as plastic bulking-agent flling and remodelling the deep dermis and subcutaneous space of the skin areas exposed to the risk of necrosis. Our work hypothesis has been to inflate a sub-dermal elastic cushion, flled with a natural ECM component, with the aim to induce a stronger tissue background resistant to the ulcerative process. Method: All the patients had an increased risk of PUs, at the sacral, ileum or heel skin. Patients were being nursed accordingly to the standard orthopaedic ward management with a pressure relieveing air mattress. The standard protocol consisted in body mobilisation every 3 hours, 24 hours a day and accurate cleaning of the skin with liquid soap and water without any towel friction and without adding any cream or lotion for the skin protection. Our flling protocol enclosed: accurate disinfection of the skin to be injected with povidone-iodine solution, followed by a local anaesthesia with 28G 13 mm needle,
njecting 1.5ml of 1% xylocaine. Then slow, deep, subcutaneous injection of cross-linked HA was performed with a 18G long needle, in order to deliver a homogeneous, soft gel layer underneath and around the whitish erythematous skin edges at risk of ulceration. Patients’ tolerability of the compound and adverse events were also recorded. Results: There were 15 patients (78–94 years old) who participated in the study. All tolerated the procedure very well and no serious side effects were declared
No skin pressure ulceration was detected in the four weeks follow-up. Conclusion: We have demonstrated the safety and tolerability of a cross-linked HA subdermal injection in PUs prevention. The compound stratifes in a soft, elastic, interstitial bulk into the deep dermis, thus reducing the exogenous pressure stress: thus, the induction of a thick hydrophilic substrate supports adequate mesenchymal and blood cells traffc to immediately restore any early or impending damage to the skin.
BACKGROUND: Proton pump inhibitors (PPIs) are a major breakthrough in the medical management of gastroesophageal reflux disease (GERD). In several patients with non erosive reflux disease symptoms (NERD) the response to PPIs is partial or limited and symptoms relief needs the administration of additional medications.
AIM: The aim of this study was to evaluate the effect of a new medical device, based on an oral fixed combination of hyaluronic acid and chondroitin-sulphate (HA+CS), in a bioadhesive carrier, in adults with symptoms of non erosive gastroesophageal reflux and with a low response to PPIs.
PATIENTS AND METHODS: Twenty patients who had experienced heartburn and/or acid regurgitation for at least 3 days during a 7 day runin period, without endoscopic mucosal breaks, were randomized in a double blind crossover study to receive four daily doses of a fixed oral combination of HA+CS and placebo for 14 days. Relief of cardinal symptoms of GERD was evaluated at the end of each period.
RESULTS: A significant greater Sum of Symptoms Intensity Difference, compared to placebo, was observed after HA+CS treatment (–2.7 vs 0.5 – p < 0.01), being both heartburn (–1.6 vs 0.5 – p
< 0.03) and acid regurgitation (–1.1 vs 0.1 – p < 0.03) significantly improved by the medical device. A speed of action ≤ 30 min was significantly more frequently reported by patients during HA+CS administration than with placebo (60% vs 30% – p = 0.05). Total disappearance of symptoms was observed in 50% of the patients compared to 10% during placebo administration (p = 0.01 between group comparison).CONCLUSIONS: A fixed combination of HA+CS has demonstrated to be effective in gastroesophageal reflux control, with a rapid onset of action.
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