scholarly journals Successful outcomes of a new combined solution of hyaluronic acid, chondroitin sulfate and poloxamer 407 for submucosal injection: animal survival study

2019 ◽  
Vol 07 (04) ◽  
pp. E576-E582 ◽  
Author(s):  
Henry Córdova ◽  
Miriam Cuatrecasas ◽  
Ana García-Rodríguez ◽  
Andrea Montenegro ◽  
Jordana Melo ◽  
...  

Abstract Background and study aims Endoscopic resection requires use of submucosal injection. This study was conducted to assess efficacy and impact on early healing of hyaluronic acid combined with chondroitin sulfate and poloxamer 407 (Ziverel) when used as a solution for submucosal injection. Materials and methods Prospective and comparative study of gastric endoscopic mucosal resection (EMR) with three groups of two Yorkshire pigs. Six submucosal cushions were created in each animal by injecting 2 mL of Ziverel (Group 1) or succinylated gelatin (SG) (Group 2), enabling 12 EMR in each group. Submucosal cushions were created with Ziverel in Group 3, without resection. Electrosurgery unit settings were the same in all cases. EMR defects and injection sites were marked with clips. The animals were sacrificed 7 days later. EMR specimen size and duration of procedure were recorded. EMR specimens and EMR scars and injection sites were evaluated by a blinded pathologist. Results We successfully performed 24 EMR (15 en-bloc and 9 piecemeal, without differences between groups 1 and 2). Mean EMR specimen dimensions were significantly larger in Group 1 (median 19 mm, range 6 – 40 vs 16.6 mm, range 5‑25; P = 0.019), without changing the electrocautery unit settings. Blinded histopathologist assessment of EMR specimens showed less fibrosis in the submucosa and a trend to fewer cautery artifacts with Ziverel and did not identify any significant differences in early healing of resection sites. Conclusion The combination of Ziverel enables EMR and does not negatively affect early healing.

2017 ◽  
Vol 05 (06) ◽  
pp. E450-E454 ◽  
Author(s):  
G. Fernández-Esparrach ◽  
M. Cuatrecasas ◽  
C. Rodríguez de Miguel ◽  
C. Sánchez-Montes ◽  
H. Córdova

Abstract Background and aims Endoscopic resection techniques require use of submucosal injection. The aim of this study was to assess a new solution that combines hyaluronic acid, chondroitin sulfate, and poloxamer 407 for submucosal injection. Methods A total of 48 gastric submucosal cushions were created in fresh porcine stomachs using gelafundin (n = 16) or the new solution diluted at 50 % (n = 16), or 80 % (n = 16). The duration of mucosal elevation was measured. In an in vivo model, 10 gastric submucosal cushions were created by injecting 2 mL of the new solution at 80 % and the animal was euthanized 30 minutes after the last injection. Results Submucosal cushions with the new solution at 80 % and 50 % concentration lasted longer than with gelafundin (23.13 ± 15.57, 13.1 ± 6.6, 3.94 ± 1.53 minutes, respectively; P = 0.000). In the in vivo study, no damage or necrosis was observed in the mucosa or muscularis propria. Conclusion The combination of hyaluronic acid, chondroitin sulfate, and poloxamer 407 produces a long-lasting submucosal cushion and does not seem to induce acute damage in the tissue making it suitable for submucosal injection.


2017 ◽  
Vol 85 (5) ◽  
pp. AB317
Author(s):  
Maria Gloria Fernandez-Esparrach ◽  
Miriam Cuatrecasas ◽  
Cristina Rodríguez de Miguel ◽  
Cristina Sánchez-Montes ◽  
Josep Llach ◽  
...  

2016 ◽  
Vol 56 (1-2) ◽  
pp. 76-85
Author(s):  
Saddiq Qazi ◽  
Benedict Kjaergaard ◽  
Fei Yang ◽  
Hong Shen ◽  
Shenguo Wang ◽  
...  

Background: The fusing of the epicardium and sternum due to adhesion is a common problem during repeated cardiac surgery and carries with it an increased risk of bleeding. The use of barriers and patches has been tested to prevent the formation of adhesions, but the very presence of a patch can provoke adhesion formation. The objective of this study was, therefore, to investigate both biodegradable and bioresorbable polylactone patches [(polycaprolactone-poly(ethylene oxide)-polycaprolactone tri-block copolymer (PCE)]. The patches were also tested with a controlled release of rapamycin, which prevents cell migration and extracellular matrix deposition. The clinical effectiveness of rapamycin in pericardial patches has not previously been examined. Materials and Methods: Three groups of 6 female Danish Landrace pigs underwent sternotomy and abrasion of the epicardium, before being randomized to either group 1 - the control group (with no patch), group 2 - PCE patch implanted between the sternum and epicardium, or group 3 - PCE patch and slow-release 1.6-mg rapamycin. After a median time period of 26 days, the pigs were euthanized and their hearts removed en bloc with the sternum, for macroscopic, histological and pathological examination. Results: Upon macroscopic examination, a significantly lower degree of adhesion in group 2, as compared to group 1 (p < 0.05), was found. Histological analysis of the tissues showed significantly more fibrosis, inflammation and foreign body granulomas (p < 0.05) in both group 2 and group 3, when compared to group 1. Conclusion: A PCE patch following sternotomy in animal subjects reduces postoperative macroscopic adhesions without reducing microscopic fibrosis or inflammation. Loading the patch with rapamycin was found not to increase the antifibrotic effect.


Neurosurgery ◽  
1990 ◽  
Vol 26 (1) ◽  
pp. 107-116 ◽  
Author(s):  
Michael W. McDermott ◽  
Felix A. Durity ◽  
Jack Rootman ◽  
W. B. Woodhurst

Abstract An extension of a combined frontotemporal and orbitozygomatic exposure was developed to remove 8 hyperostosing invasive sphenoid wing meningiomas (Group 1) and 11 complicated intraorbital tumors with and without intracranial extension (Group 2). Two separate bone flaps were created: a free frontotemporal-sphenoidal (pterional) bone flap and en bloc removal of the superior and lateral orbital margins with attached zygomatic arch. Cranio-orbital reconstruction was performed using the inner table of the pterional bone flap. Complete tumor removal was achieved in 14 patients and near total removal in 5. There was no mortality and in those patients who did not require orbital exenteration excellent to good cosmetic results were achieved in all but one case. This approach affords a wide exposure of the orbit and anterior and middle skull base, so that large tumors of the orbit and tumors involving the orbital apex, sphenoid wing, and infratemporal and pterygopalatine fossae can be removed. (Neurosurgery 26:107-116, 1990)


2016 ◽  
Vol 7 (3) ◽  
pp. 54-60
Author(s):  
G D Lazishvili ◽  
К A Egiazaryan ◽  
A A Akhpashev ◽  
M A Danilov ◽  
M A Strakhov ◽  
...  

The study of platelet-rich plasma efficacy in the treatment of patients with knee osteoarthritis (OA) was performed. 188 patients were included and divided into three groups. Group 1 - 82 patients with OA, where hyaluronic acid was used for treatment, Group 2 - 36 patients, and Platelet Rich Plasma (PRP) and hyaluronic acid were used, Group 3 - 70 patients, only PRP was used. It`s been found that the use of PRP for treatment is characterized by a pronounced clinical efficacy compared with use of hyaluronic acid, which manifests in reduced detection rate of edema, hyperthermia and hyperemia. The use of PRP leads to pain reduction in the knee joint and increase the functionality of patients, that confirmed by more pronounced declining of visual analog scale indicators, Leken index and the WOMAC index values increase. The presented results of study are consistent with authors who believe that the lack of side effects and complications when using PRP indicates the safety of its use in clinical practice.


2020 ◽  
Vol 14 (3) ◽  
pp. 63-70
Author(s):  
K. A. Berdyugin ◽  
I. V. Kadyntsev ◽  
O. V. Berdyugina ◽  
E. A. Taskina ◽  
N. G. Kashevarova

Osteoarthritis (OA) is the most common joint disease. Searching for new treatment methods and regimens for OA is relevant.Objective: to evaluate the efficiency and safety of therapy with a symptomatic sustained-release drug (Alflutop) in combination with intra-articular hyaluronic acid (HA) injection versus monotherapy with HA in patients with knee OA in routine clinical practice.Patients and methods. A post-registration open-labeled prospective comparative randomized study was conducted to assess the results of treatment in 76 patients (31 men and 45 women; mean age, 49.3±8.5 years; body mass index, 28.4±0.8 kg/m2 ) in two clinical centers in Yekaterinburg and Perm. The patients were randomized into two equal groups, were homogeneous in terms of gender, the frequency of comorbidities, and vital signs (blood pressure, heart rate, and respiratory rate).Group 1 patients received Alflutop as 1-ml daily intramuscular injections (a total of 20 injections) + 2 ml of 1% intraarticular (IA) HA solution injections three times at 1-week intervals; Group 2 patients were given 2 ml of 1% intraarticular HA solution injections three times at 1-week intervals. As an additional therapy, the use of meloxicam 7.5–15 mg/day was permitted, and, if non-steroidal anti-inflammatory drugs were contraindicated, paracetamol 1–3 g/day might be used.Results and discussion. During treatment, both groups of patients showed improvement (compared to the baseline levels). At the same time, evaluating the intergroup values revealed clear differences: a more pronounced decrease in all WOMAC indicators in Group 1 patients: pain scores, 2 [1; 3] vs. 4 [2; 5] in Group 2 (p<0.001); stiffness, 1 [0; 2] vs. 2 [1; 4] (p<0.001); functional insufficiency, 8 [3; 12] vs. 15.5 [12; 20] (p<0.001); and total WOMAC scores, 12 [7; 13] vs. 21.5 [15; 28] (p<0.001). Pain-intensity assessment using the visual analogue scale also showed the more pronounced positive effect of the combination therapy in Group 1 (p<0.001).Alflutop used in combination with HA was shown to be more preferable than HA monotherapy, which was confirmed by the results achieved for all WOMAC indicators. At 6 months, by the last visit, there were pronounced positive changes in all the analyzed parameters in both groups. At the same time, the most significant changes were recorded in the Alflutop + HA group than in the HA group (p<0.001). Perhaps, the mechanism in exhibiting the found synergistic effect of these drugs lies in their different effect on the pathogenesis of the disease. However, further study of this issue is required in multicenter randomized controlled trials.The good safety of the drugs was confirmed: not a single adverse event was revealed.Conclusion. The patients receiving the combination therapy with Alflutop + HA had the best treatment results in all the parameters assessed.


2019 ◽  
Vol 91 (5) ◽  
pp. 96-102 ◽  
Author(s):  
E A Belyaeva ◽  
O S Avdeeva

Aim. The study on the effectiveness of complex therapy for osteoarthritis (OA) of the knee joint was conducted in real clinical practice. Materials and methods. The survey involved 125 patients aged fr om 50 to 70 years (25 men and 100 women) with a diagnosis of knee joint OA (the III roentgenologic Kellgren-Lawrence stage).The average age of the patients was 62±3.21, the average duration of the disease - 9.4±2.8 years. Patients were randomly assigned to three groups of 35 people, the control group had 20 patients. Group 1 patients received non - steroidal anti - inflammatory drugs (NSAIDs) + Injectran(Chondroitin sulfate) 200 mg intramuscularly (I.M.) every other day No. 25.In group 2, patients received NSAIDs + Fermatron 1% 2 ml with an interval of 7 days intra - articularly (I.A.) No. 3. In group 3 - NSAIDs + Injectran 200 mg (I.M.) every other day No. 25 + Fermatron 1% 2 ml with an interval of 7 days (I.A.) No. 3. In the control group (20 people), patients received only NSAIDs. Evaluation of the symptoms was carried out using the WOMAC index before the start of thetherapy, after 8 and 12 weeks of treatment. The intensity of pain while walking was estimated on a visual analogue scale. Results. In the groups that received Injectran (I; group 1) or Fermatron (F; group 2), the dynamics of pain while walking reduction was comparable and had slightly more than 30% in both groups, the figures are reliable in comparison withinitial data (p


BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Isaac Kim ◽  
Hee Jun Choi ◽  
Jai Min Ryu ◽  
Se Kyung Lee ◽  
Jong Han Yu ◽  
...  

Abstract Background Increasing rates of breast cancer screening have been associated with an increasing frequency of non-palpable breast lesions detection. Preoperative breast lesion localization is essential for optimizing excision accuracy. This study aimed to evaluate the efficacy and safety of indocyanine green (ICG) hyaluronic acid injection as a novel mixture for localization. Methods We performed a prospective clinical trial with female patients who underwent surgery for non-palpable breast lesions. All patients were sequentially assigned to the control group (localization with activated charcoal), Test Group 1 (ICG-hyaluronic acid mixture 0.1 mL), or Test Group 2 (ICG-hyaluronic acid mixture 0.2 mL) by 1:1:1 ratio. Results A total of 44 patients were eligible for this study (Control Group = 14, Test Group 1 = 15, Test Group 2 = 15 patients). Fibroadenoma (n = 17, 38.6%) accounted for the largest proportion of diagnoses, and five patients (11.4%) were diagnosed with malignancies. There were no statistically significant differences in baseline characteristics among the three groups. The marking rate was over 86% in all groups, with no significant intergroup differences. Skin pigmentation was only observed in the control group. The mean accuracy of resection (the greatest diameter of the excised specimen divided by the greatest diameter of the preoperative lesion as observed using ultrasonography, with values closer to 1 reflecting a higher accuracy) was 3.7 in the control group, 2.2 in Test Group 1, and 2.1 in Test Group 2 (p = 0.037 between Controls and Test Group 1, p = 0.744 between Test Group 1 and Test Group 2, and p = 0.026 between Controls and Test Group 2). Conclusion ICG-hyaluronic acid injection is a novel method that was shown to accurately localize non-palpable breast lesions and was associated with no skin pigmentation. Further research is required to apply this method to malignant breast lesions. Trial registration “A Multicenter Open-label, Parallel, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark™ Inj. (Conc. for Fluorescence) Localization in Patients with Non-palpable Breast Lesions” was prospectively registered as a trial (ClinicalTrials. gov Identifier: NCT03743259, date of registration: May 29, 2018, https://clinicaltrials.gov/ct2/show/NCT03743259)


1989 ◽  
Vol 256 (1) ◽  
pp. R207-R216
Author(s):  
D. E. Carlson ◽  
E. J. DeMaria ◽  
R. W. Campbell ◽  
D. S. Gann

Hemorrhage of 14 ml.kg-1.5 min-1 was done in two groups of chronically prepared, splenectomized Yorkshire pigs that were conditioned behaviorally to lie in a Panepinto sling. In group 1 the conditioning included early use of active restraint. It was done before the preparative surgery and on postoperative day 3 before the experiment on day 4. In group 2 the use of active restraint was minimized during conditioning that was extended to postoperative days 4 and 5 before the experiment on day 6. Before hemorrhage, core temperature and plasma catecholamines, cortisol, adrenocorticotropin, vasopressin, and renin were greater in group 1 than in group 2; but blood volume, hematocrit, and body weight were identical. Peak hormonal concentrations were greater or more sustained during the 1st h after hemorrhage in group 1 than in group 2. Restitution of blood volume was greater in group 1 than in group 2 at 4 and 7 h. Greater total peripheral resistance at 2 h after hemorrhage and greater restitution of plasma protein by 7 h in group 1 contributed to its accelerated volume restoration. Comparison of arterial pressure and of right atrial volume (conductance catheter) between groups suggested that a greater response of arterial or right atrial stretch receptors in group 1 could not account for the results. We suggest that the method and duration of behavioral conditioning and the time for recovery from surgery are important determinants of the hemodynamic and hormonal responses to hemorrhage and their subsequent influence on the restitution of blood volume.


2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Wanwisa Suwannaloet ◽  
Wiroon Laupattarakasem ◽  
Peerapol Sukon ◽  
Siriwan Ong-Chai ◽  
Pisamai Laupattarakasem

The osteochondral healing potential of hyaluronic acid (HA) plus diacerein was evaluated in subchondral-drilling- (SCD-) induced fibrocartilage generation in rabbits. A full-thickness chondral defect was created along the patellar groove of both knees and then SCD was subsequently performed only in the left knee. A week later, the rabbits were allocated into 3 groups to receive weekly intra-articular (IA) injection for 5 weeks with normal saline solution (NSS) (group 1) or with HA (group 2 and group 3). Starting at the first IA injection, rabbits were also gavaged daily for 9 weeks with NSS (group 1 and group 2) or with diacerein (group 3). The animals were then sacrificed for evaluation. The newly formed tissue in SCD lesions showed significantly better histological grading scale and had higher content of type II collagen in HA-treated group compared to NSS control. In addition, adding oral diacerein to HA injection enhanced healing potential of HA.


Sign in / Sign up

Export Citation Format

Share Document