scholarly journals DuraSeal Exact Is a Safe Adjunctive Treatment for Durotomy in Spine: Postapproval Study

2018 ◽  
Vol 9 (3) ◽  
pp. 272-278 ◽  
Author(s):  
Kee D. Kim ◽  
Dinesh Ramanathan ◽  
Jason Highsmith ◽  
William Lavelle ◽  
Peter Gerszten ◽  
...  
Keyword(s):  
Adverse Events ◽  
Surgical Site Infection ◽  
The United States ◽  
Csf Leak ◽  
Site Infection ◽  
Serious Adverse Events ◽  
Dural Repair ◽  
Significant Difference ◽  
Csf Leakage ◽  
Deep Surgical Site Infection

Study Design: A nonrandomized, two-armed prospective study. Objective: Water-tight dural closure is paramount to the prevention of cerebrospinal fluid (CSF) leakage and associated complications. Synthetic polyethylene glycol (PEG) hydrogel has been used as an adjunct to sutured dural repair; however, its expansion postoperatively is a concern for neurological complications. A low-swell formulation of PEG sealant was introduced as DuraSeal Exact Spine Sealant System (DESS). A Post-Approval Study was performed primarily to evaluate the safety and efficacy of DESS for spinal dural repair compared to current alternatives, in a large patient population, reflecting a real-world practice. Methods: A total of 36 sites in the United States enrolled 429 patients treated with DESS as an adjunct to dural repair in the spinal sealant group and 406 patients treated with all other modalities in the control arm, from October 2011 to June 2016. The primary endpoint was the incidence of CSF leak within 90 days of operation. The secondary endpoints evaluated were deep surgical site infection and neurological serious adverse events. Results: The CSF leakage in the DESS group (6.6%) was not significantly different from the control group (6.5%) ( p = .83), and there was no significant difference in the time to first leak. The two groups had no significant differences in deep surgical site infection (1.6% versus control 2.1%, p = .61) or proportion of subjects with neurological serious adverse events (2.9% versus control 1.6%, p = .516). Conclusions: DuraSeal Exact Spinal Sealant is safe when compared to current alternatives for spinal dural repair.

scholarly journals Surgical site infection in paediatric posterior fossa surgery: does pathology matter?

2021 ◽  
Author(s):  
Malik Zaben ◽  
Alexandra Richards ◽  
Joseph Merola ◽  
Chirag Patel ◽  
Paul Leach
Keyword(s):  
Surgical Site Infection ◽  
Posterior Fossa ◽  
Csf Leak ◽  
Tumour Resection ◽  
Posterior Fossa Surgery ◽  
Site Infection ◽  
Significant Difference ◽  
Paediatric Age ◽  
Postoperative Hydrocephalus ◽  
Brain Tumour Surgery

Abstract Objectives The aim of this study was to explore the rates and potential risks of surgical site infection (SSI) after posterior fossa surgery for tumour resection in children. Methods We retrospectively reviewed our local paediatric (age < 16 years) database for all cases of posterior fossa (PF) brain tumour surgery between November 2008 and November 2019. We collected patient demographics, tumour histology/location, and the event of postoperative surgical site infection. Results Overall, 22.1% (n=15) developed SSI out of sixty-eight children undergoing PF surgery for resection of brain tumours; 73.3% of them had a confirmed diagnosis of medulloblastoma. There was no statistically significant difference in the age (5.1 ± 0.60 vs. 6.2 ± 0.97 years; p=0.47) and duration of operation (262 vs. 253 min; p = 0.7655) between the medulloblastoma group and other tumours. Although the rate of postoperative hydrocephalus was higher in the medulloblastoma group (12.9% vs. 0%), this was not associated with increased SSI. Rates of CSF leak between the 2 groups were not different. Conclusion Medulloblastoma as a pathological entity seems to carry higher risk of postoperative surgical site infection compared to other types of paediatric posterior fossa tumours. Further larger studies are required to look into this causal relationship and other risk factors that might be involved.

scholarly journals Routine Use of Feeding Jejunostomy in Pancreaticoduodenectomy: A Metaanalysis

2020 ◽  
Author(s):  
Bhavin Vasavada ◽  
Hardik Patel
Keyword(s):  
Gastric Emptying ◽  
Surgical Site Infection ◽  
Pancreatic Fistula ◽  
Delayed Gastric Emptying ◽  
Control Group ◽  
Site Infection ◽  
Feeding Jejunostomy ◽  
Significant Difference ◽  
Deep Surgical Site Infection ◽  
Meta Analyses

Aims and objectives: The primary aim of our study was to evaluate morbidity and mortality following feeding jejunostomy in pancreaticoduodenectomy compared to the control group. We also evaluated individual complications like delayed gastric emptying; post operative pancreatic fistula, superficial and deep surgical site infection. Material and Methods: The study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and MOOSE guidelines. Heterogeneity was measured using Q tests and I2.the random-effects model was used. Results: Four studies including Total of 1639 patients were included in the analysis. Total 843 patients were included in Feeding jejunostomy group and 796 patients included in control group without feeding jejunostomy. Over all morbidity was significantly higher in feeding jejunostomy group. (P = 0.001). There was no significant difference between both the groups. (P=0.07). Delayed gastric emptying was significantly higher in feeding jejunostomy group. [P=0.021]. There was no significant difference in development of pancreatic fistula between the two groups. Deep surgical site infection was significantly higher in feeding jejunostomy group. (P=0.013). Hospital stay was significantly more in feeding jejunostomy group (p&lt;0.0001). There was no significant difference between readmission; TPN requirement and time to start oral feed. Conclusion: Feeding jejunostomy seems to be associated with increased morbidity and increased length of stay.

Clinical outcome of V-Y flap with latissimus dorsi and gluteal advancement for treatment of large thoracolumbar myelomeningocele defects: a comparative study

2019 ◽  
Vol 24 (1) ◽  
pp. 75-84
Author(s):  
Mohammad Sadegh Masoudi ◽  
Mohammad Ali Hoghoughi ◽  
Fariborz Ghaffarpasand ◽  
Shekoofeh Yaghmaei ◽  
Maryam Azadegan ◽  
...  
Keyword(s):  
Mortality Rate ◽  
Comparative Study ◽  
Surgical Site Infection ◽  
Latissimus Dorsi ◽  
Primary Closure ◽  
Wound Dehiscence ◽  
Site Infection ◽  
Gluteal Muscle ◽  
Operative Duration ◽  
Csf Leakage

OBJECTIVESurgical repair and closure of myelomeningocele (MMC) defects are important and vital, as the mortality rate is as high as 65%–70% in untreated patients. Closure of large MMC defects is challenging for pediatric neurosurgeons and plastic surgeons. The aim of the current study is to report the operative characteristics and outcome of a series of Iranian patients with large MMC defects utilizing the V-Y flap and with latissimus dorsi or gluteal muscle advancement.METHODSThis comparative study was conducted during a 4-year period from September 2013 to October 2017 in the pediatric neurosurgery department of Shiraz Namazi Hospital, Southern Iran. The authors included 24 patients with large MMC defects who underwent surgery utilizing the bilateral V-Y flap and latissimus dorsi and gluteal muscle advancement. They also retrospectively included 19 patients with similar age, sex, and defect size who underwent surgery using the primary or delayed closure techniques at their center. At least 2 years of follow-up was conducted. The frequency of leakage, necrosis, dehiscence, systemic infection (sepsis, pneumonia), need for ventriculoperitoneal shunt insertion, and mortality was compared between the 2 groups.RESULTSThe bilateral V-Y flap with muscle advancement was associated with a significantly longer operative duration (p < 0.001) than the primary closure group. Those undergoing bilateral V-Y flaps with muscle advancement had significantly lower rates of surgical site infection (p = 0.038), wound dehiscence (p = 0.013), and postoperative CSF leakage (p = 0.030) than those undergoing primary repair. The bilateral V-Y flap with muscle advancement was also associated with a lower mortality rate (p = 0.038; OR 5.09 [95% CI 1.12–23.1]) than primary closure. In patients undergoing bilateral V-Y flap and muscle advancement, a longer operative duration was significantly associated with mortality (p = 0.008). In addition, surgical site infection (p = 0.032), wound dehiscence (p = 0.011), and postoperative leakage (p = 0.011) were predictors of mortality. Neonatal sepsis (p = 0.002) and postoperative NEC (p = 0.011) were among other predictors of mortality in this group.CONCLUSIONSThe bilateral V-Y flap with latissimus dorsi or gluteal advancement is a safe and effective surgical approach for covering large MMC defects and is associated with lower rates of surgical site infection, dehiscence, CSF leakage, and mortality. Further studies are required to elucidate the long-term outcomes.

scholarly journals Incidence, Management and Outcome of Delayed Deep Surgical Site Infection Following Spinal Deformity Surgery: 20-Year Experience at a Single Institution

2020 ◽  
pp. 219256822097822
Author(s):  
Muyi Wang ◽  
Liang Xu ◽  
Bo Yang ◽  
Changzhi Du ◽  
Zezhang Zhu ◽  
...  
Keyword(s):  
Surgical Site Infection ◽  
Spinal Deformity ◽  
Recurrent Infection ◽  
Implant Removal ◽  
Site Infection ◽  
Initial Surgery ◽  
Spinal Deformity Surgery ◽  
Solid Fusion ◽  
Deep Surgical Site Infection

Study Design: A retrospective study. Objectives: To investigate the incidence, management and outcome of delayed deep surgical site infection (SSI) after the spinal deformity surgery. Methods: This study reviewed 5044 consecutive patients who underwent spinal deformity corrective surgery and had been followed over 2 years. Delayed deep SSI were defined as infection involving fascia and muscle and occurring >3 months after the initial procedure. An attempt to retain the implant were initially made for all patients. If the infection failed to be eradicated, the implant removal should be put off until solid fusion was confirmed, usually more than 2 years after the initial surgery. Radiographic data at latest follow-up were compared versus that before implant removal. Results: With an average follow-up of 5.3 years, 56 (1.1%) patients were diagnosed as delayed deep SSI. Seven (12.5%) patients successfully retained instrumentation and there were no signs of recurrence during follow-up (average 3.4 years). The remaining patients, because of persistent or recurrent infection, underwent implant removal 2 years or beyond after the primary surgery, and solid fusion was detected in any case. However, at a minimum 1-year follow-up (average 3.9 years), an average loss of 9° in the thoracic curve and 8° in the thoracolumbar/lumbar curves was still observed. Conclusions: Delayed deep SSI was rare after spinal deformity surgery. To eradicate infection, complete removal of implant may be required in the majority of delayed SSI. Surgeons must be aware of high likelihood of deformity progression after implant removal, despite radiographic solid fusion.

scholarly journals Ampicillin-Ceftriaxone vs Ampicillin-Gentamicin for Definitive Therapy of Enterococcus faecalis Infective Endocarditis: A Propensity Score–Matched, Retrospective Cohort Analysis

2021 ◽  
Vol 8 (4) ◽  
Author(s):  
Niyati H Shah ◽  
Kathleen A Shutt ◽  
Yohei Doi
Keyword(s):  
Infective Endocarditis ◽  
Propensity Score ◽  
Adverse Events ◽  
Cohort Analysis ◽  
Hospital Readmissions ◽  
Length Of Hospital Stay ◽  
The United States ◽  
Aminoglycoside Resistance ◽  
Definitive Therapy ◽  
Significant Difference

Abstract Background Ampicillin-ceftriaxone (AC) has emerged as an alternative antibiotic regimen for enterococcal infective endocarditis (EIE) with reduced toxicity compared with ampicillin-gentamicin (AG), but evidence regarding its success in reducing EIE-associated death in the United States is limited. Methods We conducted a retrospective, propensity score–matched cohort analysis of EIE patients treated with AC or AG between 2010 and 2017 at 3 hospitals in Pittsburgh, Pennsylvania. We assessed all-cause 90-day mortality as the primary outcome and in-hospital mortality, length of hospital stay, hospital readmissions, adverse events, and relapse of bacteremia as the secondary outcomes. Results A total of 190 patients with EIE (100 treated with AC and 90 with AG) were included. Ninety-day mortality was significantly higher with AC than AG (21% vs 8%; P = .02). After propensity score matching, 56 patients in each group remained for the outcomes analysis. Documented aminoglycoside resistance, presence of annular or aortic abscess, and complete pacemaker removal were the significantly different variables between the 2 matched cohorts. We observed no statistically significant difference in 90-day mortality between the 2 treatment groups (11% vs 7%; P = .55). Adverse events were more common in patients treated with AG (25 vs 39; P = .0091), and more patients in the propensity score–matched AG cohort switched antibiotic regimens than in the AC group (10% vs 49%; P &lt; .0001). Conclusions Patients treated with AC demonstrate no significant differences in mortality, treatment failure, or bacteremia relapse compared with AG in a propensity score–matched EIE cohort.

scholarly journals POS0630 COMPARISON OF THE EFFICACY AND SAFETY OF ORIGINAL AND BIOSIMILAR ADALIMUMAB MOLECULES IN CHILDHOOD RHEUMATIC DISEASES

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 553.1-553
Author(s):  
K. Ulu ◽  
F. Demir ◽  
T. Coşkuner ◽  
Ş. Çağlayan ◽  
B. Sözeri
Keyword(s):  
Adverse Events ◽  
Disease Activity ◽  
Rheumatic Diseases ◽  
Behcet’S Disease ◽  
Behçet's Disease ◽  
Inactive Disease ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Significant Difference ◽  
Abp 501

Background:The TNF-α inhibitor adalimumab is a biological disease modifying anti-rheumatic drug (bDMARD) that has been used in different rheumatic diseases with a resistant course. ABP-501 is a biosimilar product (BP) of adalimumab, recently approved by the FDA and EMA. To our knowledge, there is no study assess the efficacy and safety of these two molecules on pediatric patients.Objectives:We aimed to compare the efficacy and safety of the original and biosimilar adalimumab (ABP-501) molecules in childhood rheumatic diseases.Methods:This non-interventional, retrospective, single-centre analysis carried out in Umraniye Training and Resrach Hospital, Pediatric Rheumatology Clinic, Istanbul, Turkey. The study group consisted of patients who were followed due to chronic rheumatic disease between January 1, 2016 and June 1, 2020, and received reference or biosimilar adalimumab therapy for at least three months. Demographic and clinical data of patients were collected at baseline, 3rd, 6th, and 12th months of treatment. Disease activity assessment was made with JADAS-27 in JIA patients, with SUN criteria in uveitis patients, and with Behçet’s Disease Activity Index in BD patients. Efficacy and safety of treatments were compared between reference and biosimilar adalimumab groups.Results:A total of 89 patients (65 with original and 24 with biosimilar molecule) treated with adalimumab, were included in the study. There were 45 female and 44 male in the study, and the median age at the initiation of the adalimumab was 166 months (min-max: 36-231). Of the 89 patients evaluated, the primary diagnoses of 62 were juvenile idiopathic arthritis, 13 were idiopathic uveitis, eight were Behçet’s disease, three were Blau syndrome, two were chronic recurrent multifocal osteomyelitis and one was Vogt-Koyanagi-Harada syndrome. 63 of the patients were biologic-naïve, and 13 were switched from etanercept, 11 from infliximab, and two from other bDMARDs. The median exposure time of adalimumab was 16 months (min-max:3-70) in RP and 14.5 months (min-max: 3-23) in BP. All patients had active disease before treatment. In the group treated with RP, inactive disease was achieved in 60%, 76.6% and 87.2% of the patients at the 3rd, 6th and 12th months, respectively. Also, inactive disease was achieved in 62.5%, 78.2% and 78.2% of the patients at the 3rd, 6th and 12th months in the group treated with BP, respectively. There was no statistically significant difference in efficacy between the groups at the 3rd, 6th and 12th months (p=0.83, 0.07 and 0.32). Serious adverse events were seen in one patient in each groups (lymphoma in RP group, tuberculous meningitis in BP group). Non-serious adverse events were observed in eight patients (12.3%) in the RP group and in two patients (8.3%) in the BP group, without statistically significant difference between groups (p=0.86).Conclusion:No significant difference was observed between the biosimilar adalimumab ABP-501 and RP adalimumab in terms of efficacy and safety.References:[1]Renton, William D et al. Pediatr Rheumatol Online J. 2019;17(1):67.[2]Lovell DJ, Ruperto N, Goodman S, et al. N Engl J Med. 2008;359(8):810-820.[3]Kingsbury, Daniel J et al. Clin Rheumatol 2014;33(10):1433-41.Disclosure of Interests:None declared

Safety and efficacy of the porcine small intestinal submucosa dural substitute: results of a prospective multicenter study and literature review

2007 ◽  
Vol 106 (6) ◽  
pp. 1028-1033 ◽  
Author(s):  
Ghassan K. Bejjani ◽  
Joseph Zabramski ◽  
_ _
Keyword(s):  
Wound Infection ◽  
Small Intestinal Submucosa ◽  
Csf Leak ◽  
Dural Repair ◽  
Dural Substitute ◽  
Csf Leakage ◽  
Porcine Small Intestinal Submucosa ◽  
Small Intestinal ◽  
Intestinal Submucosa

Object Dural substitutes are often needed after neurosurgical procedures to expand or replace dura mater resected during surgery. A new dural repair material derived from porcine small intestinal submucosa (SIS) was evaluated in a prospective multicenter clinical study. Methods Between 2000 and 2003, 59 patients at five different institutions underwent dural reconstruction with the SIS dural substitute, with a minimum follow up of 6 months. The primary goals of the study were to assess the efficacy and safety of the SIS dural substitute according to the rate of cerebrospinal fluid (CSF) leakage, infection, and meningitis. Chiari malformation Type I decompression (32 patients) and tumor resection (18 patients) were the most common procedures performed, with 81% of SIS grafts implanted in the posterior fossa or spine. There was one case of a CSF leak (1.7%), two cases of wound infection (3.4%), and no cases of bacterial meningitis (0%) in the 58 patients available for follow up. In both cases of wound infection, the SIS graft acted as a barrier to infection and was not removed. Intraoperatively, a watertight seal was achieved in all 59 cases. On follow-up imaging available in 27 patients there was no evidence of any adverse reaction to the graft or of cerebral inflammation. Conclusions The SIS dural substitute demonstrated substantial efficacy in these patients after a mean follow up of 7.3 ± 2.2 months. Rates of infection, CSF leakage, and meningitis were comparable to those reported for other dural substitute materials. A lack of adverse reactions to the graft, favorable safety profile, and clinical efficacy all point to the utility of this material as an alternative for dural repair.

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