An Open-label, Three-arm Pilot Study of the Safety and Efficacy of Topical Microcyn Rx Wound Care versus Oral Levofloxacin versus Combined Therapy for Mild Diabetic Foot Infections

2011 ◽  
Vol 101 (6) ◽  
pp. 484-496 ◽  
Author(s):  
Adam Landsman ◽  
Peter A. Blume ◽  
Douglas A. Jordan ◽  
Dean Vayser ◽  
Andres Gutierrez
Keyword(s):  
Success Rate ◽  
Diabetic Foot ◽  
Clinical Success ◽  
Combined Therapy ◽  
Clinical Success Rate ◽  
P Value ◽  
Open Label ◽  
Wound Irrigation ◽  
Diabetic Foot Infections ◽  
End Of Treatment

Background: This randomized, prospective, multicenter, open-label study was designed to test whether a topical, electrolyzed, superoxidized solution (Microcyn Rx) is a safe and effective treatment for mildly infected diabetic foot ulcers. Methods: Sixty-seven patients with ulcers were randomized into three groups. Patients with wounds irrigated with Microcyn Rx alone were compared with patients treated with oral levofloxacin plus normal saline wound irrigation and with patients treated with oral levofloxacin plus Microcyn Rx wound irrigation. Patients were evaluated on day 3, at the end of treatment on day 10 (visit 3), and 14 days after completion of therapy for test of cure (visit 4). Results: In the intention-to-treat sample at visit 3, the clinical success rate was higher in the Microcyn Rx alone group (75.0%) than in the saline plus levofloxacin group (57.1%) or in the Microcyn Rx plus levofloxacin group (64.0%). Results at visit 4 were similar. In the clinically evaluable population, the clinical success rate at visit 3 (end of treatment) for patients treated with Microcyn Rx alone was 77.8% versus 61.1% for the levofloxacin group. The clinical success rate at visit 4 (test of cure) for patients treated with Microcyn Rx alone was 93.3% versus 56.3% for levofloxacin plus saline–treated patients. This study was not statistically powered, but the high clinical success rate (93.3%) and the P value (P = .033) suggest that the difference is meaningfully positive for Microcyn Rx–treated patients. Conclusions: Microcyn Rx is safe and at least as effective as oral levofloxacin for mild diabetic foot infections. (J Am Podiatr Med Assoc 101(6): 484–496, 2011)

scholarly journals Selective Arterial Embolization of Renal Angiomyolipoma: Efficacy, Tumor Volume Reduction and Complications

2021 ◽  
Vol 73 (5) ◽  
Author(s):  
Walailak Chaiyasoot ◽  
Jirawadee Yodying ◽  
Thanita Limsiri
Keyword(s):  
Success Rate ◽  
Clinical Success ◽  
Three Dimensional ◽  
Clinical Success Rate ◽  
Arterial Embolization ◽  
P Value ◽  
Renal Angiomyolipoma ◽  
Tumor Rupture ◽  
Selective Arterial Embolization ◽  
Density Histogram

Objective: To evaluate the efficacy and complications of selective arterial embolization in renal angiomyolipoma and to identify predictive factors for tumor rupture.Materials and Methods: Overall, 21 patients with 25 renal angiomyolipoma (AML) underwent selective arterial embolization (SAE) between January 2008 and June 2019, comprising 15 cases involving prophylaxis embolization of a tumor >4 cm diameter and 10 involving embolization for a ruptured tumor. Multidetector computed tomography (MDCT) was performed pre- and post-SAE, using the 2D tumor diameter in the ruptured AMLs. Three-dimensional volumetry and density histogram were performed for determining the total tumor volume, fat, and angiomyogenic component reduction in the unruptured AMLs. The predictive factors for tumor rupture, the treatment outcome and complications were analyzed. Results: The clinical success rate was 84% (21/25 cases) and the technical success rate was 96% (24/25 cases). The 3D volume post-SAE within 1-3 months showed a greater decrement of the enhanced angiomyogenic component than the fat component, with median percentages of -62.2% and -18.4%, respectively (p-value = 0.333). Minor complications were post-embolization syndrome (5 case, 20%) and minimal renal infarction (4 cases, 16%). Renal abscesses were the major complications (3 cases, 12%). A factor associated with tumor rupture was the presence of an intra-tumoral aneurysm (p-value < 0.05).Conclusion: SAE is an effective treatment for renal AML with a high technical and clinical success rate and limited complications. Three-dimensional volume measurement and density histogram analysis might be better tools than two-dimensional CT to evaluate post-SAE response, which is crucial for management planning.

Clinical effectiveness of high dose versus standard dose of meropenem in ventilator-associated pneumonia caused by multidrug-resistant bacteria: a randomized single-blind clinical trial

2020 ◽  
Vol 20 ◽  
Author(s):  
Mahila Monajati ◽  
Shahram Ala ◽  
Masoud Aliyali ◽  
Roya Ghasemian ◽  
Fatemeh Heidari ◽  
...  
Keyword(s):  
Success Rate ◽  
Sofa Score ◽  
Dose Group ◽  
Clinical Success ◽  
Standard Dose ◽  
Clinical Success Rate ◽  
High Dose Group ◽  
Resistant Bacteria ◽  
High Dose ◽  
Ventilator Associated Pneumonia

Background: Meropenem standard doses are based on the minimum inhibitory concentration of sensitive pathogens and the pharmacokinetic parameter of not critically ill patients. We compared the efficacy of high versus standard dose of meropenem in ventilator-associated pneumonia (VAP). Methods: 24 out of 34 eligible patients were randomized to receive meropenem 3 g q8h (high dose group, 11 patients) or 2 g q8h (standard dose group, 13 patients) as a 3h infusion. Primary outcome was considered as clinical success that was defined as stable hemodynamic, improved sequential organ failure assessment (SOFA) score, stable or improved PaO2/FiO2 after 7 days. A sputum culture was taken before intervention. Results: Clinical success rate was not significantly different between the high and standard dose group (54.5% vs. 38.5%, P= 0.431). There was a significant difference in reduction of clinical pulmonary infection score (CPIS) compared to high dose with standard group (P=0.038). SOFA score declined significantly in high dose group through the study (P=0.006). A shorter duration of VAP treatment was recorded in high dose group (P=0.061). We did not observe any significant adverse event related to meropenem. Acinetobacter spp. (34.8%), Klebsiella spp. (32.6%) and, Pseudomonas aeruginosa (19.5%) isolated more frequently from sputum cultures. Conclusion: Treatment with high dose of meropenem seems to be safe. However, it did not provide significantly higher clinical success rate in comparison with the standard dose, but could be considered as an appropriate empirical treatment in patients with severe infection due to reducing in SOFA and CPIS.

Ferric sulfate as pulpotomy agent in primary teeth: twenty month clinical follow-up

2000 ◽  
Vol 24 (4) ◽  
pp. 269-272 ◽  
Author(s):  
Hamijeta Ibricevic ◽  
Qumasha Al-Jame
Keyword(s):  
Success Rate ◽  
Primary Teeth ◽  
Root Resorption ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Ferric Sulfate ◽  
Primary Molar ◽  
Molar Teeth ◽  
The Moment

Seventy primary molar teeth, carious exposed, symptom free, without any sign of root resorption in children aged from 3 to 6 years (main age 4.3yr) were treated with conventional pulpotomy procedures. Ferric sulfate 15.5% solution (applied for 15 second for 35 teeth) and formocresol solution (five minute procedure of Buckley's formula for next 35 teeth) have been used as pulpotomy agents. In both groups, pulp stumps were covered with zinc-oxide eugenol paste. Permanent restorations were stainless steel crowns. Clinical check up was every three-months and radiographic follow-up time was six and twenty months after treatment. Our results within this period revealed 100% clinical success rate in both groups. Radiographic success rate was in both groups 97.2%, while in 2.8% cases has shown internal root resorption. On the basis of these results, we can recommend ferric sulfate as a pulpotomy agent in primary teeth in substitution for formocresol at the moment.

Comparison of alteplase and urokinase for pharmacomechanical thrombolysis of clotted hemodialysis access

2018 ◽  
Vol 20 (5) ◽  
pp. 501-506 ◽  
Author(s):  
Ru Yu Tan ◽  
Suh Chien Pang ◽  
Swee Ping Teh ◽  
Kian Guan Lee ◽  
Tze Tec Chong ◽  
...  
Keyword(s):  
Success Rate ◽  
Vascular Access ◽  
Clinical Success ◽  
Univariate Analysis ◽  
Clinical Success Rate ◽  
Skin Dose ◽  
Hemodialysis Access ◽  
Procedure Time ◽  
Technical Success Rate ◽  
Tertiary Teaching

Background: Percutaneous pharmacomechanical thrombolysis is increasingly used to salvage thrombosed hemodialysis access. We aim to evaluate the effectiveness of alteplase compared to urokinase in percutaneous pharmacomechanical thrombolysis clotted access. Methods: Records of patients who underwent pharmacomechanical thrombolysis at Interventional Nephrology Suite in a tertiary teaching hospital from 1 January 2016 to 31 December 2016 were reviewed. Technical and clinical success rates, thrombosis-free and cumulative survivals, procedure time, and radiation dose imparted to patients were compared for pharmacomechanical thrombolysis with urokinase versus alteplase. Results: A total of 122 incident patients underwent pharmacothrombolysis (n = 53 for urokinase, n = 69 for alteplase) during the study period. The mean dose of urokinase and alteplase used was 176,897 ± 73,418 units and 3.7 ± 0.8 mg, respectively. Pharmacomechnical thrombolysis using urokinase versus alteplase has similar technical success rate (98.1% vs 97.1%, p = 0.599), clinical success rate (88.7% vs 97.1%, p = 0.068), complication rate (9.4% vs 13.0%, p = 0.373), and primary patency rates at 3 months (57.1% vs 70.1%, p = 0.106). Thrombosis-free survivals of the vascular access were 113.2 (35.3, 196) days versus 122 (84, 239) days (p = 0.168). Cumulative survivals were 239 (116, 320) vs 213 (110.5, 316.5) days (p = 0.801). Procedure time, fluoroscopy time, skin dose, and dose were significantly lower for pharmacomechanical thrombolysis using alteplase compared to urokinase (p = 0.045, p < 0.0001, p = 0.006, p = 0.001, respectively). Stenting was found to be associated with successful dialysis following thrombolysis on univariate analysis (odds ratio: 9.167, 95% confidence interval: 1.391–19.846, p = 0.021), although this was no longer significant in multivariate analysis (p = 0.078). Conclusion: Alteplase is an effective and safe alternative to urokinase for pharmacomechanical thrombolysis of clotted vascular access.

scholarly journals The Efficacy and Safety of Balloon Enteroscopy-Assisted Endoscopic Retrograde Cholangiography in Pediatric Patients with Surgically Altered Gastrointestinal Anatomy

2021 ◽  
Vol 10 (17) ◽  
pp. 3936
Author(s):  
Kensuke Yokoyama ◽  
Tomonori Yano ◽  
Atsushi Kanno ◽  
Eriko Ikeda ◽  
Kozue Ando ◽  
...  
Keyword(s):  
Success Rate ◽  
Pediatric Patients ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Endoscopic Retrograde Cholangiography ◽  
Adult Patients ◽  
Efficacy And Safety ◽  
Duodenal Papilla ◽  
Endoscopic Retrograde ◽  
Balloon Enteroscopy

Balloon enteroscopy-assisted endoscopic retrograde cholangiography (BEA-ERC) is useful and feasible in adults with pancreatobiliary diseases, but its efficacy and safety have not been established in pediatric patients. We compared the success rate and safety of BEA-ERC between adults and pediatric patients. This single-center retrospective study reviewed 348 patients (pediatric: 57, adult: 291) with surgically altered gastrointestinal anatomies who underwent BEA-ERC for biliary disorders from January 2007 to December 2019. The success rate of reaching the anastomosis or duodenal papilla was significantly lower in pediatric patients than in adult patients (66.7% vs. 88.0%, p < 0.01). The clinical success rate was also significantly lower in pediatric patients (64.9% vs. 80.4%, p = 0.014). The rate of adverse events was significantly higher in pediatric patients than in adults (14.2% vs. 7.7%, p = 0.037). However, if the anastomotic sites were reached in pediatric patients, the treatment was highly successful (97.3%). The time of reaching target site was significantly longer in pediatric patients than in adult patients. This study shows that BEA-ERC in pediatric patients is more difficult than that in adult patients. However, in patients where the balloon enteroscope was advanced to the anastomosis, clinical outcomes comparable to those in adults can be achieved.

Endoscopic Ultrasound-Guided Drainage and Treatment of Symptomatic Pancreatic Fluid Collection following Acute or Acute-on-Chronic Pancreatitis – A Single Center Case Series

2018 ◽  
Vol 143 (06) ◽  
pp. 577-585
Author(s):  
Dominik Kaczmarek ◽  
Jacob Nattermann ◽  
Christian Strassburg ◽  
Tobias Weismüller
Keyword(s):  
Success Rate ◽  
Endoscopic Ultrasound ◽  
Clinical Success ◽  
Fluid Collection ◽  
Clinical Success Rate ◽  
Long Term Results ◽  
Pancreatic Fluid Collection ◽  
Endoscopic Procedures ◽  
Pancreatic Fluid

Abstracts Introduction Pancreatic fluid collection (PFC) is a common complication of acute pancreatitis. Endoscopic ultrasound (EUS)-guided drainage, which is often followed by direct endoscopic necrosectomy (DEN), has become the primary approach to treat PFC, including pancreatic pseudocysts (PP) and walled-off necrosis (WON). We aimed to determine retrospectively the short- and long-term results of patients treated in our endoscopy unit and to identify parameters that are associated with treatment efficacy and outcome. Methods The data of 41 consecutive patients with post-pancreatitic PFC, who underwent endoscopic transmural intervention between 2014 and 2016, were analyzed retrospectively. After an initial EUS-guided puncture, one or more plastic stents were placed and DEN was performed if necrotic tissue remained. Results The mean diameter of the PFC was 74.0 ± 4.8 mm. Of the PFCs, 29.3% were classified as PP and 70.7% as WON. Altogether, 196 transmural endoscopic procedures were performed, including 73 endoscopic necrosectomies in a subgroup of 21 patients (20 WON, 1 PP). Initial technical success was achieved in 97.6% of patients and the short-term clinical success rate was 90.2%. The long-term clinical success rate was 82.9%, since four patients died from septic shock and/or multiple organ failure and three patients developed recurrent PFC some months after the initial discharge from endoscopic treatment. Procedural complications were registered in 9 patients during 10 of 196 endoscopic procedures (5.1%): bleeding (6), cardiorespiratory insufficiency (2), perforation with pneumoperitoneum (1), aspiration with respiratory insufficiency (1), and non-perforating superficial damage of the gastric wall (1). Neither the size of the PFC nor the initial value of C-reactive protein (CRP) or other biochemical markers were correlated with efficacy or outcome of treatment. Only the cumulative number of days with CRP > 50 mg/L significantly correlated with the number of follow-up endoscopic sessions and DEN. Fungal colonization of PFC correlated significantly (p < 0.05) with the risk of mortality (44% vs. 0%), need for intensive care treatment (66.7% vs. 25%), and sepsis (55.6% vs. 12.5%). Conclusions We confirm that EUS-guided drainage followed by DEN in patients with solid necrotic material is an effective and relatively safe therapeutic approach. Prolonged elevation of CRP and fungal colonisation of the PFC are associated with a worse course of the disease.

scholarly journals Long-Term Management of Recurrent Cholecystitis after Initial Conservative Treatment: Endoscopic Transpapillary Gallbladder Stenting

2018 ◽  
Vol 2018 ◽  
pp. 1-7
Author(s):  
Hideki Kamada ◽  
Hideki Kobara ◽  
Naohito Uchida ◽  
Kiyohito Kato ◽  
Takayuki Fujimori ◽  
...  
Keyword(s):  
High Risk ◽  
Acute Cholecystitis ◽  
Success Rate ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Technical Success ◽  
Technical Success Rate ◽  
High Risk Patients ◽  
Risk Patients

Background. Endoscopic transpapillary gallbladder stenting (ETGBS) is an effective procedure for treating high-risk patients with acute cholecystitis and severe comorbidities. However, the efficacy of ETGBS for recurrent cholecystitis (RC) remains unclear. This study aimed to explore its efficacy in patients with RC for whom cholecystectomy is contraindicated because of its high surgical risk.Methods. Data on 19 high-risk patients who had undergone ETGBS for RC after initial conservative therapy in our institution between June 2006 and May 2012 were retrospectively examined. The primary outcome was the clinical success rate, which was defined as no recurrences of acute cholecystitis after ETGBS until death or the end of the follow-up period. Secondary outcomes were technical success rate and adverse events (AEs).Results. The clinical success rate of ETGBS was 100%, the technical success rate 94.7%, and AE rate 5%: one patient developed procedure-related mild acute pancreatitis. The clinical courses of all patients were as follows: four died of nonbiliary disease, and the remaining 15 were subsequently treated conservatively. The median duration of follow-up was 14.95 months (range 3–42 months).Conclusions. ETGBS is an effective alternative for managing RC in high-risk patients with severe comorbidities.

Analysis of Outcomes of Endovascular Embolisation: A Cross-Sectional Multicenter Study on 46 Visceral Artery Pseudoaneurysms

2021 ◽  
Author(s):  
Mohammad Koriem Mahmoud Omar ◽  
Moustafa H. M. Othman ◽  
Robert A. Morgan ◽  
Abdelkarem Hasan Abdallah ◽  
Hany M. A. Seif ◽  
...  
Keyword(s):  
Success Rate ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Visceral Artery ◽  
Endovascular Management ◽  
Cross Sectional ◽  
Technical Success Rate ◽  
Endovascular Embolisation ◽  
Visceral Artery Aneurysms ◽  
Perioperative Complication

Abstract Purpose Visceral artery aneurysms are subdivided into true aneurysms and pseudoaneurysms. Visceral artery pseudoaneurysms (VAPAs) are uncommon in clinical practice but may have serious clinical outcomes up to death. Endovascular management is a safe effective alternative option to traditional surgical procedures. This study assesses the outcome of different embolic materials and techniques used in the endovascular management of visceral artery pseudoaneurysms. Materials and methods This is a multicentric prospective analysis of endovascular embolisation of 46 VAPAs with a mean pseudoaneurysm size of 13 ± 11.35 mm. Management using coils only was done in 28/46 patients (60.87%), NBCA glue only in 16/46 patients (34.78%), combined coils and NBCA glue in 1/46 patient (2.17%), and Amplatzer plugs only in 1 patient (2.17%). The management techniques were sac packing in 9/46 patients (19.57%), inflow occlusion in 28/46 patients (60.87%) and trapping in 9/46 patients (19.57%). Results The overall clinical success rate was 93.48%, the overall perioperative complication rate was 15.22% and 30-day mortality was zero. For the coil subgroup (n = 28), the clinical success was 92.86%, while the subgroup of NBCA glue (n = 16) showed clinical success of 93.75%. There was no significant statistical difference between clinical success among coil, and NBCA glue subgroups (P > 0.05). The technical success rate was 100%. Effectiveness of the procedures during the follow-up was 97.83%. Target lesion re-intervention rate was 2.17%. Conclusion Transarterial embolisation can provide high technical and clinical success rates with low perioperative complication and re-intervention rates, as well as satisfactory procedure effectiveness in the management of VAPAs.

One-year results of gastric peroral endoscopic myotomy for refractory gastroparesis: a French multicenter study

Endoscopy ◽  
2020 ◽  
Author(s):  
Olivier Ragi ◽  
Jérémie Jacques ◽  
Julien Branche ◽  
Sarah Leblanc ◽  
Geoffroy Vanbiervliet ◽  
...  
Keyword(s):  
Success Rate ◽  
Multicenter Study ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Peroral Endoscopic Myotomy ◽  
Gastric Retention ◽  
Endoscopic Myotomy ◽  
Cardinal Symptom

Abstract Background: Data on the long-term outcomes of gastric peroral endoscopic myotomy (G-POEM) for refractory gastroparesis are lacking. We report the results of a large multicenter long-term follow-up study of G-POEM for refractory gastroparesis. Methods: This was a retrospective multicenter study of all G-POEM operations performed in seven expert French centers for refractory gastroparesis with at least 1 year of follow-up. The primary endpoint was the 1-year clinical success rate, defined as at least a 1-point improvement in the Gastroparesis Cardinal Symptom Index (GCSI). Results: 76 patients were included (60.5 % women; age 56 years). The median symptom duration was 48 months. The median gastric retention at 4 hours (H4) before G-POEM was 45 % (interquartile range [IQR] 29 % – 67 %). The median GCSI before G-POEM was 3.6 (IQR 2.8 – 4.0). Clinical success was achieved in 65.8 % of the patients at 1 year, with a median rate of reduction in the GCSI score of 41 %. In logistic regression analysis, only a high preoperative GCSI satiety subscale score was predictive of clinical success (odds ratio [OR] 3.41, 95 % confidence interval [CI] 1.01 – 11.54; P = 0.048), while a high rate of gastric retention at H4 was significantly associated with clinical failure (OR 0.97, 95 %CI 0.95 – 1.00; P = 0.03). Conclusions: The results confirm the efficacy of G-POEM for the treatment of refractory gastroparesis, as evidenced by a 65.8 % clinical success rate at 1 year. Although G-POEM is promising, prospective sham-controlled trials are urgently needed to confirm its efficacy and identify the patient populations who will benefit most from this procedure.

scholarly journals Pharmacokinetics, Safety, and Clinical Outcomes of Omadacycline in Women with Cystitis: Results from a Phase 1b Study

2019 ◽  
Vol 63 (5) ◽  
Author(s):  
J. Scott Overcash ◽  
Pouru Bhiwandi ◽  
Lynne Garrity-Ryan ◽  
Judith Steenbergen ◽  
Stephen Bai ◽  
...  
Keyword(s):  
Clinical Success ◽  
Open Label ◽  
Once Daily ◽  
Open Label Study ◽  
End Of Treatment ◽  
Urine Concentrations ◽  
Phase 1B ◽  
Blood And Urine Samples ◽  
Group 3 ◽  
Group 2

ABSTRACT Omadacycline, an aminomethylcycline antibiotic, is approved as once-daily intravenous (i.v.) and oral (p.o.) monotherapy for acute bacterial skin and skin structure infections and for community-acquired bacterial pneumonia, and it is under development for treatment of urinary tract infection (UTI). This is a phase 1b, randomized, open-label study of omadacycline in women with cystitis (defined as UTI symptoms and a positive urine leukocyte esterase test). Patients received omadacycline for 5 days (group 1: 200 mg intravenously on day 1, then 300 mg orally every 24 h [q24h]; group 2: 300 mg orally every 12 h [q12h] on day 1, then 300 mg orally q24h; group 3: 450 mg orally q12h on day 1, then 450 mg orally q24h). Blood and urine samples were collected over 5 days. Investigator-assessed clinical response was determined at end of treatment (EOT; day 6) and posttreatment evaluation (PTE; 5 to 9 days after last dosing). A total of 31 women were treated. At steady state (day 5), the range of mean omadacycline urine concentrations over 24 h across the groups was 17.94 to 48.12 μg/ml. The most common treatment-emergent adverse events were gastrointestinal (including nausea [60% to 73%] and vomiting [20% to 40%]) and were generally mild and transient. Investigator-determined clinical success was observed in 94% and 84% of patients at EOT and PTE, respectively, with similar results across groups. A favorable microbiological response at PTE was observed in 78% of patients who had a baseline pathogen. Omadacycline is partially excreted in urine and appears to be safe and well tolerated. These preliminary results indicate that omadacycline warrants further evaluation in larger controlled UTI studies.

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