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Efficacy and safety of 0.6% sodium alginate solution in endoscopic submucosal dissection for esophageal and gastric neoplastic lesion: A randomized controlled study.
Uemura, N, Oda, I, Saito, Y, Ono, H, Fujisaki, J, Matsuhashi, N, Ohata, K, Yahagi, N, Yada, T, Satoh, M, et al
Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society. 2019;(4):396-404
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Abstract
OBJECTIVES Sodium alginate (SA) solution has characteristic viscoelasticity. We aimed to determine efficacy and safety of 0.6% SA for submucosal injection during endoscopic submucosal dissection (ESD) in patients with localized neoplastic lesion in the esophageal and gastric mucosa. METHODS We conducted a randomized controlled study at six major hospitals in Japan including 130 patients with endoscopically localized neoplastic lesion in the esophageal and gastric mucosa and eligible for ESD. Patients were randomly assigned to SA or 0.4% sodium hyaluronate (SH) group (control); ESD was performed using a submucosal injection of SA/SH. As a primary outcome measure, non-inferiority of SA against SH was investigated using en bloc complete resection in ESD and formation and maintenance of mucosal elevation upon injection as an efficacy index. Adverse events during the study were evaluated as safety outcome measures. This study was registered with Pharmaceuticals and Medical Devices Agency (clinical trial no. 28-277/2016-18; clinical trial identification no. KP2013-009_C001). RESULTS Efficacy rate of submucosal injection during ESD was 91.7% (55/60) and 88.7% (55/62) in the SA and SH groups, respectively, demonstrating non-inferiority of SA against SH. Adverse events for which a causal relationship with submucosal injection solution could not be eliminated were noted in 8.2% (5/61) and 4.7% (3/64) in the SA and SH groups, respectively, but symptoms disappeared without treatment/after drug administration in both groups. CONCLUSIONS In Japan, 0.4% SH is the only commercially approved formulation for submucosal injection during ESD. The study results may expand submucosal injection solution options in clinical practice.
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Three-Arm Randomized Trial of Sodium Alginate for Preventing Radiation-Induced Esophagitis in Locally Advanced Non-Small Cell Lung Cancer Receiving Concurrent Chemoradiotherapy: The OLCSG1401 Study Protocol.
Ninomiya, K, Ichihara, E, Hotta, K, Sone, N, Murakami, T, Harada, D, Oze, I, Kubo, T, Tanaka, H, Kuyama, S, et al
Clinical lung cancer. 2017;(2):245-249
Abstract
Concurrent chemoradiotherapy (CRT) is the standard of care for locally advanced non-small cell lung cancer (LA-NSCLC). However, this intensive therapy often causes severe esophagitis, which could deteriorate a patient's quality of life (QOL), leading to poor treatment compliance. Sodium alginate, approved in Japan for gastritis, is sufficiently highly viscous to remain in the esophageal mucosa, providing a protective effect in the esophagus. To investigate whether this compound has a preventive effect against severe esophagitis in patients receiving concurrent CRT, we plan a 3-arm randomized trial of sodium alginate with 2 different schedules versus water. The primary endpoint is set as the proportion of patients with grade ≥ 3 esophagitis using the Common Terminology Criteria for Adverse Events, version 4.0. With stratification by institute, performance status, and percentage of the esophageal volume receiving >35 Gy, the patients will be randomly assigned to 1 of the following groups: sodium alginate initiated concomitantly with CRT (group A), sodium alginate initiated soon after the development of extremely mild esophagitis during CRT (group B), or water administered throughout CRT (group C). Assuming that the proportion of grade ≥ 3 esophagitis would be 8% in groups A and B and 27% in group C, the required sample size would be 200 patients, with 70% power and 5% α. The secondary endpoints include QOL, the frequency of additional prescriptions of analgesics, treatment response, and survival. The results of the present study will clarify whether sodium alginate can prevent esophagitis in patients with LA-NSCLC undergoing CRT.
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One-year follow-up results from AUGMENT-HF: a multicentre randomized controlled clinical trial of the efficacy of left ventricular augmentation with Algisyl in the treatment of heart failure.
Mann, DL, Lee, RJ, Coats, AJ, Neagoe, G, Dragomir, D, Pusineri, E, Piredda, M, Bettari, L, Kirwan, BA, Dowling, R, et al
European journal of heart failure. 2016;(3):314-25
Abstract
AIMS: AUGMENT-HF was an international, multicentre, prospective, open-label, randomized, controlled evaluation testing the hypothesis that Algisyl (injectable calcium alginate hydrogel) is superior to standard medical therapy (SMT) for improving functional capacity and clinical outcomes in patients with advanced heart failure (HF). We previously reported results following 6 months of follow-up. This report presents the results from 1 year of extended follow up for this clinical trial. METHODS AND RESULTS We enrolled 78 patients with advanced HF, randomized (1:1), to Algisyl with SMT or SMT alone as previously reported. Patient inclusion criteria were LVEF ≤35%, peak VO2 of 9.0-14.5 mL/min/kg and LV end-diastolic diameter (LVEDD) index 30-40 mm/m(2) (LVEDD/body surface area). Patients must have been on stable, evidence-based therapy for HF. A total of 58 patients, mean age 62.3 ± 9.6 years, with ischaemic (57.7%) or non-ischaemic (42.3%) HF completed 12 months of follow-up. Treatment with Algisyl was associated with improved peak VO2 at 12 months; treatment effect vs. control of +2.10 mL/kg/min (95% confidence interval 0.96-3.24, P < 0.001). Statistically significant improvements were observed for VO2 at anaerobic threshold, 6-min walk test distance, and NYHA functional class (all P < 0.001). Through 12 months of follow-up there were 4 (10.5%) deaths in the control group and 9 (22.5%) deaths in the Algisyl group. CONCLUSIONS Algisyl in addition to SMT was more effective than SMT alone for providing sustained 1-year benefits in exercise capacity, symptoms, and clinical status for patients with advanced HF. These data support larger clinical evaluations of this novel therapy.
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A prospective randomised open label study to evaluate the potential of a new silver alginate/carboxymethylcellulose antimicrobial wound dressing to promote wound healing.
Beele, H, Meuleneire, F, Nahuys, M, Percival, SL
International wound journal. 2010;(4):262-70
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Abstract
The aim of this study was to observe both the clinical signs and symptoms of wounds at risk of infection, that is critically colonised (biofilm infected) and antimicrobial-performance of an ionic silver alginate/carboxymethylcellulose (SACMC) dressing, in comparison with a non silver calcium alginate fibre (AF) dressing, on chronic venous leg and pressure ulcers. Thirty-six patients with venous or pressure ulcers, considered clinically to be critically colonised (biofilm infected), were randomly chosen to receive either an SACMC dressing or a non silver calcium AF dressing. The efficacy of each wound dressing was evaluated over a 4-week period. The primary study endpoints were prevention of infection and progression to wound healing. The SACMC group showed a statistically significant (P = 0.017) improvement to healing as indicated by a reduction in the surface area of the wound, over the 4-week study period, compared with AF controls. In conclusion, the SACMC dressing showed a greater ability to prevent wounds progressing to infection when compared with the AF control dressing. In addition, the results of this study also showed an improvement in wound healing for SACMC when compared with a non silver dressing.
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Evaluation of calcium alginate nasal packing (Algostéril) versus Polyvinyl acetal (Merocel) for nasal packing after inferior turbinate resection.
Chevillard, C, Rugina, M, Bonfils, P, Bougara, A, Castillo, L, Crampette, L, Pandraud, L, Samardzic, M, Peynègre, R
Rhinology. 2006;(1):58-61
Abstract
Nasal packing is commonly used to control postoperative bleeding in patients undergoing endonasal surgical procedures. Bleeding and pain on packing removal are frequently reported. The principal objective of this study was to investigate the efficacy and safety of Algosteril to control post-operative nasal bleeding. The secondary objective was to assess nasal bleeding and pain on packing removal, and to evaluate the endoscopic appearance of nasal mucosa 9 days after the procedure. This open, multicenter, randomized, controlled study was conducted on 50 patients undergoing partial bilateral inferior turbinectomy, packed with Algosteril on one side versus Polyvinyl acetal tampon (Merocel) on the other side following a left/right randomization. Both nasal packs effectively prevented post-operative bleeding. However, bleeding on packing removal was statistically less frequent and less severe with Algosteril than with Polyvinyl acetal (p = 0.016). In addition, pain was statistically lower with Algosteril than with Polyvinyl acetal (p = 0.0001). A trend to a better healing of the wound on day 9 was observed with Algosteril, leading us to further investigations. Algosteril nasal packing is as effective as Polyvinyl acetal in preventing postoperative bleeding following partial inferior turbinate resection. Its removal, however, is less traumatic for the nasal mucosa and less painful for the patient, therefore improving patient's comfort.
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Evaluation of two calcium alginate dressings in the management of venous ulcers.
Limová, M
Ostomy/wound management. 2003;(9):26-33
Abstract
Calcium alginate dressings facilitate the management of highly exudating wounds such as venous ulcers. To evaluate and compare the performance of two calcium alginate dressings in the management of venous ulcers, a prospective, randomized, controlled clinical study was conducted among 19 outpatients at two wound clinics in California. Ten patients (53%) were treated with Alginate A and nine patients (47%) with Alginate B. Dressings were changed weekly and patients were followed for a maximum of 6 weeks or until the venous ulcer no longer required the use of an alginate dressing. At each dressing change, the wound was assessed and dressing performance evaluated. Absorbency of exudate, patient comfort during wear, ease of removal, adherence to wound bed, dressing residue following initial irrigation, patient comfort during removal, ease of application, and conformability were assessed. Patients using Alginate A experienced significantly less foul odor (P = 0.02) and less denuded skin (P = 0.04) than Alginate B at follow-up wound assessments. With the exception of conformability, Alginate A was rated significantly better than Alginate B (P less than or equal to 0.05) in all dressing performance assessments. No significant healing differences were observed. As the different performance characteristics of various calcium alginate dressings become more obvious in clinical practice, further study is warranted to determine their optimal effectiveness.
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Efficacy and tolerance of calcium alginate versus vaseline gauze dressings in the treatment of diabetic foot lesions.
Lalau, JD, Bresson, R, Charpentier, P, Coliche, V, Erlher, S, Ha Van, G, Magalon, G, Martini, J, Moreau, Y, Pradines, S, et al
Diabetes & metabolism. 2002;(3):223-9
Abstract
BACKGROUND The study aimed at comparing the efficacy and tolerance of an alginate wound dressing with a vaseline gauze dressing in the treatment of diabetic foot lesions. METHODS This open-label randomized multicenter controlled study was designed to assess the effect of an up to 6-week treatment with either calcium alginate or vaseline gauze dressings. Lesions were either acute or chronic, under cleansing, and with a surface area of 1-50 cm(2); osteomyelitis and severe hypovascularization were non-inclusion criteria. Dressings were changed every day then, once granulation had occurred, every 2 to 3 days. Primary outcome was the proportion of patients with granulation tissue over 75% of the wound area and having a 40% decrease in wound surface area; secondary outcomes were pain on dressing changes, the number of dressing changes, and adverse events. RESULTS Seventy-seven patients were enrolled. Due to the premature cessation of treatment in 13 patients, it was decided to reduce the period of the efficacy analysis to 4 weeks (without revising the criteria of efficacy). The success rate was of 42.8% in the calcium alginate group and of 28.5% in the vaseline gauze group (not significant difference). A subsequent analysis of granulation tissue surfaces covering the wounds at week 4 (all surfaces taken together) showed a superiority of calcium alginate (p=0.04). Pain on dressing change was lower in the calcium alginate group (p=0.047) and the total number of dressing changes tended also to be lower (p=0.07). Adverse events, which occurred 4 times in the calcium alginate group and 6 times in the other, were judged independent of the treatments. CONCLUSIONS As compared with vaseline gauze, calcium alginate appears to be more appropriate for topical treatment of diabetic foot lesions in terms of both healing and tolerance.