scholarly journals Lidocaine for dinutuximab associated pain? A multicenter retrospective observational cohort study

2021 ◽  
Author(s):  
Julianna Featherly ◽  
Sarabeth Wojnowicz ◽  
Kelly Steidl ◽  
Jeni Burgess
Keyword(s):  
Neuropathic Pain ◽  
Primary Outcome ◽  
Neuroblastoma Cells ◽  
Nerve Fibers ◽  
Infusion Time ◽  
Immune Mediated ◽  
Academic Medical ◽  
Significant Difference ◽  
Electronic Chart ◽  
Observational Cohort

Dinutuximab, an immune-mediated therapy used in the treatment of high-risk neuroblastoma targets the protein disialoganglioside (GD2) present on neuroblastoma cells, neurons, and peripheral nerve fibers. Off target effects could lead to severe nerve pain. Pain regimens including continuous infusion opioids are required during the first treatment course. Our institution utilizes a combination of intravenous (IV) lidocaine infusions and morphine for the treatment of dinutuximab-associated neuropathic pain. The primary outcome of this study was to compare morphine equivalents for cycle one of dinutuximab at an institution that uses IV lidocaine (primary) versus those that do not (comparison). Secondary outcomes included both dinutuximab infusion time and safety of IV lidocaine. A retrospective, multi-centered, electronic chart review was performed at three tertiary academic medical centers. Patients between 0-18 years of age during their first course of dinutuximab were included to evaluate the primary outcome of adjuvant morphine equivalents needed. Total morphine equivalents at the primary institution were 1.87 mg/kg vs 1.79 mg/kg at the comparison institutions (p=0.413). Dinutuximab infusion time was significantly lower at the primary institution: 610.5 minutes vs 676.23 minutes (p=0.046). Only one patient at the primary institution experienced nausea, vomiting and paresthesias. This study did not find a statistically significant difference in morphine equivalents between patients who received IV lidocaine and those who did not. However, we did find that use of IV lidocaine resulted in a statistically significant lower dinutuximab infusion time and that it is a safe adjuvant medication in the treatment of dinutuximab-associated neuropathic pain.

INR Response to Low-Dose Vitamin K in Warfarin Patients

2021 ◽  
pp. 106002802199323
Author(s):  
Caitlin E. Kulig ◽  
A. Joshua Roberts ◽  
A. Shaun Rowe ◽  
Hahyoon Kim ◽  
William E. Dager
Keyword(s):  
Vitamin K ◽  
Primary Outcome ◽  
Low Dose ◽  
International Normalized Ratio ◽  
Mortality Rates ◽  
Observational Cohort Study ◽  
Significant Difference ◽  
Observational Cohort ◽  
Reduction Effect ◽  
Retrospective Observational Cohort Study

Background Literature suggests that 2 mg of vitamin K intravenously (IV) provides a similar effect as 10 mg to reverse warfarin. Doses <5 mg haven’t been studied in depth. Objective The objective was to determine the international normalized ratio (INR) reduction effect of ultra low-dose (ULD) IV vitamin K. Methods This retrospective, observational cohort study compared IV vitamin K doses of 0.25-0.5 mg (ULD) versus 1-2 mg (standard low dose [SLD]). The primary outcome assessed ΔINR at 36 hours; secondary outcomes assessed ΔINR at 12 hours and 30-day venous thromboembolism (VTE) and mortality rates. Results Of 88 patients identified (median baseline INR [IQR], 5.1 [3.1, 7.3] vs 4.5 [2.8, 8.2], ULD vs SLD, respectively), 59 had an INR at 12 hours. The ULD had fewer 12-hour INR values <2, with no statistical difference in the ΔINR at 12 hours between the ULD and SLD cohorts (median ΔINR, 2.2 [1.1, 3.4] vs 2.2 [1.1, 6.3]; P = 0.54; median INR, 2.3 vs 1.8). A total of 41 patients had both a 12- and 36-hour INR. No significant difference in the ΔINR between the 12- and 36-hour values occurred (median ΔINR, 0.52 [0.2, 0.91] vs ΔINR, 0.46 [0.18, 0.55]; P = 0.61), suggesting no rebound or excessive reversal and no difference in 30-day rates of VTE ( P > 0.99) or death ( P = 0.38). Conclusion and Relevance ULD IV vitamin K reversed INR similarly to doses of 1-2 mg without rebound. A ULD strategy may be considered in patients requiring more cautious reversal.

scholarly journals P305 Effectiveness and Safety of Vedolizumab in Biologic-Naïve Patients: Real-World Data from the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD)

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S333-S333
Author(s):  
F Macaluso ◽  
W Fries ◽  
S Renna ◽  
A Viola ◽  
M Muscianisi ◽  
...  
Keyword(s):  
Clinical Response ◽  
Real World ◽  
Primary Outcome ◽  
Real World Data ◽  
Mayo Score ◽  
Significant Difference ◽  
Bowel Diseases ◽  
Observational Cohort ◽  
Inflammatory Bowel

Abstract Background Biologic-naïve patients treated with Vedolizumab (VDZ) are largely underrepresented in real-world cohorts. We performed a multicentre, observational, cohort study on the effectiveness and safety of VDZ as treatment for Crohn’s disease (CD) and ulcerative colitis (UC) among biologic-naïve subjects. Methods Data of consecutive biologic-naïve patients with CD and UC treated with VDZ from July 2016 to December 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). The primary outcome was the clinical response at 14 and 52 weeks evaluated with Harvey Bradshaw Index in CD and partial Mayo score in UC. Results 172 consecutive patients (CD: n=88; UC: n=84; median age 66.0 years) were included, with a median follow-up of 58.8 weeks. After 14 weeks, a clinical response was reported in 68.2% of patients with CD and 67.9% of patients with UC treated with VDZ, including 45.5% patients in the CD group and 46.4% patients in the UC group who achieved steroid-free remission. After 52 weeks, a clinical response was reported in 77.4% of CD and in 73.8% of UC patients treated with VDZ, including 59.7% patients in the CD group and 60.7% patients in the UC group who achieved steroid-free remission. All differences between CD and UC were not statistically significant. Cox survival analysis showed no significant difference in the probability of treatment discontinuation between CD and UC patients (log-rank p=0.73). Conclusion This large, real-world, multicenter study demonstrated the effectiveness and safety of VDZ as a first-line biologic, showing high rates of clinical response and steroid-free remission at both induction and maintenance.

scholarly journals Long-Term Outcomes in the Management of Central Neuropathic Pain Syndromes: A Prospective Observational Cohort Study

2018 ◽  
Vol 45 (5) ◽  
pp. 545-552 ◽  
Author(s):  
Michael D. Staudt ◽  
Alexander John Clark ◽  
Allan S. Gordon ◽  
Mary E. Lynch ◽  
Pat K. Morley-Forster ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Primary Outcome ◽  
Data Sets ◽  
Long Term Outcomes ◽  
Peripheral Neuropathic Pain ◽  
Central Neuropathic Pain ◽  
Pain Syndromes ◽  
Observational Cohort

AbstractBackground:Central neuropathic pain syndromes are a result of central nervous system injury, most commonly related to stroke, traumatic spinal cord injury, or multiple sclerosis. These syndromes are distinctly less common than peripheral neuropathic pain, and less is known regarding the underlying pathophysiology, appropriate pharmacotherapy, and long-term outcomes. The objective of this study was to determine the long-term clinical effectiveness of the management of central neuropathic pain relative to peripheral neuropathic pain at tertiary pain centers.Methods:Patients diagnosed with central (n=79) and peripheral (n=710) neuropathic pain were identified for analysis from a prospective observational cohort study of patients with chronic neuropathic pain recruited from seven Canadian tertiary pain centers. Data regarding patient characteristics, analgesic use, and patient-reported outcomes were collected at baseline and 12-month follow-up. The primary outcome measure was the composite of a reduction in average pain intensity and pain interference. Secondary outcome measures included assessments of function, mood, quality of life, catastrophizing, and patient satisfaction.Results:At 12-month follow-up, 13.5% (95% confidence interval [CI], 5.6-25.8) of patients with central neuropathic pain and complete data sets (n=52) achieved a ≥30% reduction in pain, whereas 38.5% (95% CI, 25.3-53.0) achieved a reduction of at least 1 point on the Pain Interference Scale. The proportion of patients with central neuropathic pain achieving both these measures, and thus the primary outcome, was 9.6% (95% CI, 3.2-21.0). Patients with peripheral neuropathic pain and complete data sets (n=463) were more likely to achieve this primary outcome at 12 months (25.3% of patients; 95% CI, 21.4-29.5) (p=0.012).Conclusion:Patients with central neuropathic pain syndromes managed in tertiary care centers were less likely to achieve a meaningful improvement in pain and function compared with patients with peripheral neuropathic pain at 12-month follow-up.

Cranial crassicaudiasis in two coastal dolphin species from South Africa is predominantly a disease of immature individuals

2020 ◽  
Vol 139 ◽  
pp. 93-102 ◽  
Author(s):  
MF Van Bressem ◽  
P Duignan ◽  
JA Raga ◽  
K Van Waerebeek ◽  
N Fraijia-Fernández ◽  
...  
Keyword(s):  
South Africa ◽  
Bone Development ◽  
Bottlenose Dolphins ◽  
Fatal Outcome ◽  
Population Level ◽  
Cape Coast ◽  
Osteolytic Lesions ◽  
Immune Mediated ◽  
Significant Difference ◽  
The Difference

Crassicauda spp. (Nematoda) infest the cranial sinuses of several odontocetes, causing diagnostic trabecular osteolytic lesions. We examined skulls of 77 Indian Ocean humpback dolphins Sousa plumbea and 69 Indo-Pacific bottlenose dolphins Tursiops aduncus, caught in bather-protecting nets off KwaZulu-Natal (KZN) from 1970-2017, and skulls of 6 S. plumbea stranded along the southern Cape coast in South Africa from 1963-2002. Prevalence of cranial crassicaudiasis was evaluated according to sex and cranial maturity. Overall, prevalence in S. plumbea and T. aduncus taken off KZN was 13 and 31.9%, respectively. Parasitosis variably affected 1 or more cranial bones (frontal, pterygoid, maxillary and sphenoid). No significant difference was found by gender for either species, allowing sexes to be pooled. However, there was a significant difference in lesion prevalence by age, with immature T. aduncus 4.6 times more likely affected than adults, while for S. plumbea, the difference was 6.5-fold. As severe osteolytic lesions are unlikely to heal without trace, we propose that infection is more likely to have a fatal outcome for immature dolphins, possibly because of incomplete bone development, lower immune competence in clearing parasites or an over-exuberant inflammatory response in concert with parasitic enzymatic erosion. Cranial osteolysis was not observed in mature males (18 S. plumbea, 21 T. aduncus), suggesting potential cohort-linked immune-mediated resistance to infestation. Crassicauda spp. may play a role in the natural mortality of S. plumbea and T. aduncus, but the pathogenesis and population level impact remain unknown.

Reducing Gingivitis Remotely using the iGAM mHealth app (part 2): Prospective Observational Study (Preprint)

2020 ◽  
Author(s):  
Guy Tobias ◽  
Assaf B Spanier
Keyword(s):  
Oral Health ◽  
Tooth Loss ◽  
Prospective Observational Study ◽  
Dental Clinics ◽  
Significant Difference ◽  
Observational Cohort ◽  
Group 2 ◽  
And Behavior ◽  
Oral Hygiene Habits ◽  
Group 1

BACKGROUND Gingivitis is a non-painful, inflammatory condition that can be treated with home remedies. Left untreated gingivitis can lead to tooth loss. Periodic dental examinations are important for early diagnosis and treatment of gum diseases. In order to contain the spread of the corona virus, governments, including in Israel, have restricted movements of their citizens which has caused routine dental checkups to be postponed. OBJECTIVE This study aimed to examine the ability of an mHealth app- iGAM to reduce gingivitis. METHODS A prospective observational cohort study was performed, 160 unpaid participants were divided into 2 equal groups and downloaded the iGAM app. Group 1 photographed their gums weekly for eight weeks. Group 2 photographed their gums at the time of recruitment and 8 weeks later. After photo submission, the participants received the message "It is recommended to read the information contained within the app regarding maintaining oral hygiene habits". A single blinded researcher examined the images and scored them according to the Modified Gingival Index (MGI). RESULTS The average age of group 1 was 26.77 (S.D. ± 7.43), and 28.53 (S.D. ± 10.44) for group 2. The majority were male (74.7% in group 1 vs. 66.7% in group 2), most participants described themselves as "secular", most were "single", non-smokers (74.7% vs. 78.4%) and did not take medications (85.3% vs. 78.4%). 126 subjects completed the study. A statistically significant difference (P <.001) was found in the dependent variable (MGI) in a linearly negative manner. As time passed, the gum condition improved, there were significantly lower gingivitis scores in group 1 (M = 1.16, S.D. ± 1.18) compared to group 2 (M = 2.16, S.D. ± 1.49), after eight weeks. Those with more recent dental visits had a lower MGI (p = .037). No association was found between knowledge and behavior, most participants were familiar with the recommendations for maintaining oral health, yet they only performed some. CONCLUSIONS A dental selfie taken once a week using an mHealth app (iGAM) reduced the signs of gingivitis and promoted oral health. During the current pandemic where social distancing recommendations may be causing people to avoid dental clinics, this app can remotely promote gum health. CLINICALTRIAL The protocol was approved by Hadassah research ethics committee (IRB, 0212-18-HMO)

scholarly journals Intracameral Bevacizumab Versus Sub-Tenon’s Mitomycin C as Adjuncts to Trabeculectomy: 3-Year Results of a Prospective Randomized Study

2021 ◽  
Vol 10 (10) ◽  
pp. 2054
Author(s):  
Gerasimos Kopsinis ◽  
Dimitrios Tsoukanas ◽  
Dimitra Kopsini ◽  
Theodoros Filippopoulos
Keyword(s):  
Mitomycin C ◽  
Primary Outcome ◽  
Randomized Study ◽  
Primary Outcome Measure ◽  
Complication Rates ◽  
Filtration Surgery ◽  
Significant Difference ◽  
Exfoliative Glaucoma

Conjunctival wound healing determines success after filtration surgery and the quest for better antifibrotic agents remains active. This study compares intracameral bevacizumab to sub-Tenon’s mitomycin C (MMC) in trabeculectomy. Primary open-angle or exfoliative glaucoma patients were randomized to either bevacizumab (n = 50 eyes) or MMC (n = 50 eyes). The primary outcome measure was complete success, defined as Intraocular Pressure (IOP) > 5 mmHg and ≤ 21 mmHg with a minimum 20% reduction from baseline without medications. Average IOP and glaucoma medications decreased significantly in both groups at all follow-up points compared to baseline (p < 0.001), without significant difference between groups at 3 years (IOP: bevacizumab group from 29 ± 9.4 to 15 ± 3.4 mmHg, MMC group from 28.3 ± 8.7 to 15.4 ± 3.8 mmHg, p = 0.60; Medications: bevacizumab group from 3.5 ± 0.9 to 0.5 ± 1, MMC group from 3.6 ± 0.7 to 0.6 ± 1.1, p = 0.70). Complete success, although similar between groups at 3 years (66% vs. 64%), was significantly higher for bevacizumab at months 6 and 12 (96% vs. 82%, p = 0.03; 88% vs. 72%, p = 0.04, respectively) with fewer patients requiring medications at months 6, 9 and 12 (4% vs. 18%, p = 0.03; 6% vs. 20%, p = 0.04; 8% vs. 24%, p = 0.03, respectively). Complication rates were similar between groups. In conclusion, intracameral bevacizumab appears to provide similar long-term efficacy and safety results as sub-Tenon’s MMC after trabeculectomy.

Veno-arterial extracorporeal membrane oxygenation with concomitant Impella versus concomitant intra-aortic-balloon-pump for cardiogenic shock

Perfusion ◽  
2021 ◽  
pp. 026765912110339
Author(s):  
Shek-yin Au ◽  
Ka-man Fong ◽  
Chun-Fung Sunny Tsang ◽  
Ka-Chun Alan Chan ◽  
Chi Yuen Wong ◽  
...  
Keyword(s):  
Extracorporeal Membrane Oxygenation ◽  
Mechanical Circulatory Support ◽  
Primary Outcome ◽  
Left Ventricular ◽  
Circulatory Support ◽  
Queen Elizabeth Hospital ◽  
Intra Aortic Balloon Pump ◽  
Membrane Oxygenation ◽  
Significant Difference ◽  
Va Ecmo

Introduction: The intra-aortic balloon pump (IABP) and Impella are left ventricular unloading devices with peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO) in place and later serve as bridging therapy when VA-ECMO is terminated. We aimed to determine the potential differences in clinical outcomes and rate of complications between the two combinations of mechanical circulatory support. Methods: This was a retrospective, single institutional cohort study conducted in the intensive care unit (ICU) of Queen Elizabeth Hospital, Hong Kong. Inclusion criteria included all patients aged ⩾18 years, who had VA-ECMO support, and who had left ventricular unloading by either IABP or Impella between January 1, 2018 and October 31, 2020. Patients <18 years old, with central VA-ECMO, who did not require left ventricular unloading, or who underwent surgical venting procedures were excluded. The primary outcome was ECMO duration. Secondary outcomes included length of stay (LOS) in the ICU, hospital LOS, mortality, and complication rate. Results: Fifty-two patients with ECMO + IABP and 14 patients with ECMO + Impella were recruited. No statistically significant difference was observed in terms of ECMO duration (2.5 vs 4.6 days, p = 0.147), ICU LOS (7.7 vs 10.8 days, p = 0.367), and hospital LOS (14.8 vs 16.5 days, p = 0.556) between the two groups. No statistically significant difference was observed in the ECMO, ICU, and hospital mortalities between the two groups. Specific complications related to the ECMO and Impella combination were also noted. Conclusions: Impella was not shown to offer a statistically significant clinical benefit compared with IABP in conjunction with ECMO. Clinicians should be aware of the specific complications of using Impella.

scholarly journals FRI0382 EFFECTS OF GENICULAR NERVE BLOCK IN PATIENTS WITH KNEE OSTEOARTHRITIS WHO HAVE NEUROPATHIC OR NOCICEPTIVE PAIN

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 788.2-789
Author(s):  
B. Tas ◽  
P. Akpinar ◽  
I. Aktas ◽  
F. Unlu Ozkan ◽  
I. B. Kurucu
Keyword(s):  
Neuropathic Pain ◽  
Knee Osteoarthritis ◽  
Nerve Block ◽  
Intractable Pain ◽  
Ultrasound Guided ◽  
Lidocaine Group ◽  
Knee Oa ◽  
Significant Difference ◽  
Genicular Artery ◽  
Saline Solutions

Background:Genicular nerve block (GNB) is a safe and effective therapeutic procedure for intractable pain associated with chronic knee osteoarthritis (OA)(1). There is increasing support for the neuropathic component to the knee OA pain. Investigators proposed that targeting treatment to the underlying pain mechanism can improve pain management in knee OA (2). There is a debate on injectable solutions used in nerve blocks (3).Objectives:To investigate the analgesic and functional effects of USG-guided GNB in patients with chronic knee OA (with/without neuropathic pain) and to evaluate the efficacy of the anesthetic and non-anesthetic solutions used.Methods:Ninety patients with chronic knee OA between the ages of 50-80 were divided into two groups with and without neuropathic pain according to painDETECT questionnaire (4). The groups were randomized into three subgroups to either the lidocaine group (n=30) or dextrose group (n=29) or saline solutions (n=31). After the ultrasound-guided GNB, quadriceps isometric strengthening exercises and cryotherapy were recommended to the patients. Visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne-algofunctional Index were assessed at baseline and at 1 week, 1 and 3 months later after the procedure.Results:Statistically significant improvement was observed in all groups with or without neuropathic pain according to VAS values at the 1stweek, 1stmonth and 3rdmonth compared to baseline (p<0.05). Statistically significant improvement was observed in all groups with neuropathic pain according to painDETECT values at the 1stweek, 1stmonth and 3rdmonth compared to baseline (p<0.05). There was a statistically significant improvement in the groups without neuropathic pain which received dextrose and saline solutions, according to painDETECT values, but not in the group which received lidocain at the 1stweek, 1stmonth and 3rdmonth compared to baseline (p>0.05). There was a statistically significant improvement in all groups with or without neuropathic pain according to WOMAC and Lequesne total scores at the 1stweek, 1stmonth and 3rdmonth compared to baseline (p<0.05).Conclusion:We conclude that in patients with chronic knee OA (with/without neuropathic pain), the use of GNB with USG is an analgesic method which provides short to medium term analgesia and functional recovery and has no serious side effects. The lack of significant difference between the anesthetic and non-anesthetic solutions used in the GNB suggests that this may be a central effect rather than a symptom of peripheral nerve dysfunction. It suggests that injection may have an indirect effect through nociceptive processing and changes in neuroplastic mechanisms in the brain. In addition, we can say that regular exercise program contributes to improved physical function with the decrease in pain.References:[1]Kim DH et al. Ultrasound-guided genicular nerve block for knee osteoarthritis: a double-blind, randomized controlled trial of local anesthetic alone or in combination with corticosteroid. Pain Physician 2018;21:41-51.[2]Thakur M et.al. Osteoarthritis pain: nociceptive or neuropathic?. Nat Rev Rheumatol 2014:10(6):374.[3]Lam SKH et al. Transition from deep regional blocks toward deep nerve hydrodissection in the upper body and torso: method description and results from a retrospective chart review. BioMed Research International Volume 2017;7920438.[4]Hochman JR et al. Neuropathic pain symptoms in a community knee OA cohort. Osteoarthritis Cartilage. 2011 Jun;19(6):647-54.Fig. 1:Ultrasound- guided identification of GNB target sites. Doppler mode. White arrows indicate genicular arteries.A.Superior medial genicular artery.B.Inferior medial genicular artery.C.Superior lateral genicular artery.Disclosure of Interests:None declared

scholarly journals Interest of a standardized hypnotic message for the reduction of pain and anxiety in cancer patients treated by capsaicin patch for neuropathic pain: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rémi Etienne ◽  
Myriam Laurent ◽  
Aline Henry ◽  
Antoine Bioy ◽  
Julia Salleron ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neuropathic Pain ◽  
Rating Scales ◽  
Controlled Trial ◽  
Standard Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Numerical Rating ◽  
Reduction Of Pain ◽  
The Impact

Abstract Background Neuropathic pain is characterized by spontaneous painful symptoms. Medical therapies include the use of a capsaicin 8% patch (Qutenza®, Grünenthal Gmbh, Germany), and patients may experience a sharp burning sensation at application and removal of the patch. This study aimed to evaluate the impact of playing a standardized hypnosis recording during application, on the pain and anxiety induced by capsaicin treatment. Methods In a randomized, controlled trial, we assessed the benefits of the intervention firstly on pain and secondly on anxiety, as measured using numerical rating scales. All patients had application of the capsaicin patch, including the possibility for the patient to apply a cold patch. Participants were randomly assigned to one of 3 groups, namely the “Standard group” (no intervention), “Hypnosis group”, in which a standardized hypnotic message was played during application, or the “Music group” in which relaxing music was played during application of the patch. Results Sixty-nine patients were included. Overall, there was no significant difference in pain scores between groups (p = 0.355). Compared to standard application, anxiety was significantly lower in the hypnosis group after application (p = 0.007), with no significant difference between the standard and music arms (p = 0.271), or between the hypnosis and music arms (p = 0.423). Conclusions Listening to a standardized hypnotic message during application of a capsaicin patch was found to significantly lower anxiety. These findings indicate that the use of a hypnotic message can reduce discomfort and warrant its evaluation in other indications of pain or anxiety during treatment procedures. Trial registration NCT02822625.

scholarly journals Comparison of Simulation-Based versus Cadaveric-Tissue-Based Ocular Trauma Training on Novice Ophthalmologists: Repair of Corneal Laceration Model

2021 ◽  
Vol 13 (01) ◽  
pp. e57-e65
Author(s):  
Boonkit Purt ◽  
Timothy Ducey ◽  
Sean Sykes ◽  
Joseph F. Pasternak ◽  
Denise S. Ryan ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Wound Closure ◽  
Ocular Trauma ◽  
Controlled Trial ◽  
Preliminary Evaluation ◽  
Skills Acquisition ◽  
Visual Axis ◽  
Significant Difference ◽  
Skills Laboratory ◽  
Corneal Laceration

Abstract Purpose The aim of this study was to evaluate whether the simulated tissue models may be used in place of animal-based model for corneal laceration repair for surgical skills acquisition. Design Prospective randomized controlled trial. Participants Seventy-nine military and civilian 2nd- and 3rd-year ophthalmology residents and 16 staff ophthalmologists participating in the Tri-Service Ocular Trauma Skills Laboratory at the Uniformed Services University (Bethesda, MD). Methods Resident ophthalmologists underwent preliminary evaluation of their ability to close a 5-mm linear, full-thickness corneal laceration involving the visual axis. They then were randomized to undergo 90 to 120 minutes of either simulator-based (SIM) or swine cadaveric-tissue-based (CADAVER) corneal laceration repair. The same evaluation was performed post training. On a more limited basis, the study was repeated for attending ophthalmologists to act as a pilot for future analysis and test efficacy for “refresher” training. Main Outcome Measures Successful wound closure with secondary outcomes of suture length, tension, depth, and orientation, as graded by attending ophthalmologists. Results No significant difference in CADAVER versus SIM groups in the primary outcome of watertight wound closure of the corneal laceration. CADAVER group performed better than SIM group for certain metrics (suture depth, p = 0.009; length, p = 0.003; and tension, p = 0.043) that are associated with poor wound closure and increased amount of induced corneal astigmatism. For attending ophthalmologists, six of the eight in each group (SIM and CADAVER) retained or improved their skills. Conclusions For resident ophthalmologists, SIM training is sufficient for achieving the primary outcome of watertight wound closure. However, CADAVER training is superior for wound metrics for the ideal closure. For attending ophthalmologists, SIM training may be useful for retention of skills.

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