scholarly journals Topical Cepae Extract-Heparin Sodium-Allantoin Gel versus Placebo on Hypertrophic Thyroidectomy Scars: A Randomized, Double- Blinded, Split-Scar Controlled Trial

2012 ◽  
Vol 27 (2) ◽  
pp. 12-16
Author(s):  
Michael Paolo M. Tapangco ◽  
Waynn-Nielsen Destriza ◽  
Bernardo D. Dimacali ◽  
Mildred B. Olveda
Keyword(s):  
Controlled Trial ◽  
Language Translation ◽  
Small Sample ◽  
Post Treatment ◽  
Assessment Scale ◽  
Heparin Sodium ◽  
Scar Assessment ◽  
Significant Difference ◽  
Physical Attributes ◽  
Double Blinded

Objective:  Topical cepae extract-heparin sodium-allantoin gel is one of the  many non-invasive scar treatments available to improve the appearance and physical attributes of scars. This paper aims to compare the effectiveness of topical cepae extract-heparin sodium-allantoin gel versus placebo based on appearance and physical attributes of hypertrophic thyroidectomy scars. Methods:             Design: Randomized, double-blinded, split-scar controlled trial             Setting: Out-Patient Department of a Tertiary Government Hospital             Participants:  20 patients with hypertrophic thyroidectomy scars had each side of the scar randomly assigned treatment with topical extract.-cepae-heparin sodium-allantoin gel or placebo (glycerine gel). Each product was applied two times daily for 6 weeks, and scars were evaluated prior to initiation of treatment and after 6 weeks by patients and one observer. Pre- and post-treatment photo documentation and scar evaluation using a local language translation of the Patient and Observer Scar Assessment Scale  (POSAS) were completed for each side of the scar.   Results:  There was no significant  difference in effectiveness of topical cepae extract-heparin sodium-allantoin gel versus placebo for both the patient scale (p = 0.91)  and observer scale (p = 0.87)  in appearance and physical attributes of a thyroidectomy scar. Conclusions: Topical cepae extract-heparin sodium-allantoin gel was not proven to be superior to the placebo as scar therapy in all parameters assessed by the Filipino translation of POSAS. The small sample size, duration of hypertrophic scar, duration of treatment, and validity and reliability of the Filipino translation of POSAS may have affected our results; and periodic subjective and objective assessments with multi-observer evaluation of scars and pre- and post- treatment photographs may be considered for further studies. Keywords: Topical Cepae Extract-Heparin Sodium-Allantoin Gel, Glycerine, Patient and Observer Scar Assessment Scale, thyroidectomy scar, scar

scholarly journals Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized Controlled Trial

2020 ◽  
Vol 7 ◽  
pp. 205435812094043
Author(s):  
A. Dave Nagpal ◽  
Andrea Cowan ◽  
Linna Li ◽  
Graeme Nusca ◽  
Linrui Guo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Weight Gain ◽  
Controlled Trial ◽  
Coronary Revascularization ◽  
Small Sample ◽  
Resource Limitations ◽  
Randomized Controlled ◽  
Surgery Patient ◽  
Double Blinded

Background: Despite decades of investigation, the balance of clinical risks and benefits of fluid supplementation with starch remain unresolved. Patient-centered outcomes have not been well explored in a “real-world” trial in cardiac surgery. Objective: We sought to compare a starch-based fluid strategy with a saline-based fluid strategy in the cardiac surgery patient. Design: A pragmatic blinded randomized controlled trial comparing starch-based with saline-based fluid strategy. Setting: A large tertiary academic center in London Ontario between September 2009 and February 2011. Participants: Patients undergoing planned, isolated coronary revascularization. Measurements: Serum creatinine and patient weight were measured daily postoperatively. Methods: Patients were randomized to receive 6% hydroxyethyl starch (Voluven) or saline for perioperative fluid requirements. Fluid administration was not protocolized. Co-primary outcomes were incidence of acute kidney injury (AKI) and maximum postoperative weight gain. Secondary outcomes included bleeding, transfusion, inotropic and ventilator support, and fluid utilization. Results: The study was prematurely terminated due to resource limitations. A total of 69 patients (19% female, mean age = 65) were randomized. Using RIFLE criteria for AKI, “risk” occurred in 12 patients in each group (risk ratio [RR] = 1.0; 95% confidence interval [CI] = 0.5-1.9; P = 1.00), whereas “injury” occurred in 7 of 35 (20%) and 3 of 34 (9%) of patients in the starch and saline groups, respectively (RR = 2.3; 95% CI = 0.6-8.1; P = .31). Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups. Limitations: The study had to be prematurely terminated due to resource limitations which led to a small sample size which was not sufficiently powered to detect a difference in the primary outcomes. Conclusions: This pragmatic double-blinded randomized controlled trial revealed a number of interesting hypothesis-generating trends and confirmed the feasibility of undertaking a logistically complex trial in a pragmatic fashion.

scholarly journals Effectiveness Of Topical Application Of Chlorhexidine And Prevailing Practices On Episiotomy Wound Among Postnatal Mothers

2014 ◽  
Vol 2 (1) ◽  
Author(s):  
Rincy Michael ◽  
Soney N Toppo ◽  
Varsha Hariharan
Keyword(s):  
Wound Healing ◽  
Topical Application ◽  
Controlled Trial ◽  
Demographic Data ◽  
Assessment Scale ◽  
Research Centre ◽  
Control Group ◽  
Significant Difference ◽  
Postnatal Mothers ◽  
Experimental Group

Puerperium is a period when the mother experiences intense physical and emotional stress due to exhaustion, anxiety and excitement. Each mother has to adjust to physical changes in her own body due to involution and lactation as well as cope up with the new demands on her time and emotions made by the new born baby. Episiotomy, despite evidences that it is an unnecessary intervention, is one of the most common surgical procedures performed during the second stage of labour, especially in primigravida woman. Thus, a randomized controlled trial to assess the effectiveness of topical application of chlorhexidine and prevailing practices on episiotomy wound among postnatal mothers at selected hospital of Indore was undertaken. True experimental approach with pre test post test research design was adopted. Simple random sampling was taken to select 40 postnatal mothers with episiotomy wound and three days postpartum hospital stay in Choithram Hospital & Research Centre, Indore as per the inclusion criteria. Data was collected with help of questionnaire for socio demographic data and obstetrical data and the wound healing was assessed by REEDA wound healing assessment scale. Samples in the experimental group were applied with chlorhexidine on episiotomy wound and the samples in the control group received routine care with betadine or nadoxin. Post assessment score was taken on third day (evening) by REEDA wound assessment scale. Finding of the study related to effectiveness of chlorhexidine among postnatal mothers in experimental group revealed that there was a significant difference in the healing of episiotomy wound by the application of chlorhexidine among postnatal mothers in experimental group at t19 = 11.40 at the level of p< 0.001. Hence it was inferred that topical application of chlorhexidine on episiotomy wound promotes wound healing.

scholarly journals Nutritional Support and Clinical Outcome of Severe and Critical Patients With COVID-19 Pneumonia

2020 ◽  
Vol 7 ◽  
Author(s):  
Xiangfeng Yue ◽  
Min Li ◽  
Yu Wang ◽  
Jing Zhang ◽  
Xinyi Wang ◽  
...  
Keyword(s):  
Protein Intake ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Antiviral Treatment ◽  
Small Sample ◽  
Nutrition Support ◽  
Calorie Intake ◽  
Viral Shedding ◽  
Significant Difference ◽  
Critical Patients

Background: In 2020, a novel coronavirus has spread throughout the world. More than four hundred thousand people have died of SARS-CoV-2 pneumonia, most of which were severe and critical patients. No effective antiviral treatment has been verified thus far. Nutrition support has become one of the important treatments for severe and critical patients.Methods: In this retrospective study, 26 severe patients and 22 critical patients with laboratory confirmed COVID-19 were enrolled. We recorded the diet and nutritional treatments in severe and critical patients. Baseline characteristics and clinical outcomes of severe and critical patients were also collected.Results: Average calorie intake of severe patients (19.3 kcal/kg/d) was higher than critical patients (15.3 kcal/kg/d) (P = 0.04). Protein intake was similar in the two groups (0.65 and 0.62 g/kg per day, respectively; P = 0.29). There was no significant difference in the median duration of viral shedding between the severe and critical patients (P = 0.354).Conclusions: A permissive underfeeding strategy that restricts non-protein calories but preserves protein intake is feasible for critical patients with SARS-CoV-2 pneumonia. Viral shedding duration of critical patients was the same as severe patients who received standard feeding. Nevertheless, evidence of the conclusion is not sufficient because of small sample size. To show the real clinical benefit of permissive low-calorie and adequate protein intake in critical SARS-CoV-2 pneumonia patients, a large and pragmatic randomized controlled trial is needed.

scholarly journals Tetrahydrobiopterin ameliorates the exaggerated exercise pressor response in patients with chronic kidney disease: a randomized controlled trial

2016 ◽  
Vol 310 (10) ◽  
pp. F1016-F1025 ◽  
Author(s):  
Ann M. Lin ◽  
Peizhou Liao ◽  
Erin C. Millson ◽  
Arshed A. Quyyumi ◽  
Jeanie Park
Keyword(s):  
Nitric Oxide ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Pressor Response ◽  
Controlled Trial ◽  
Treated Group ◽  
Handgrip Exercise ◽  
Significant Difference ◽  
Double Blinded ◽  
Oxide Synthase

Chronic kidney disease (CKD) patients have an exaggerated increase in blood pressure (BP) during rhythmic handgrip exercise (RHG 20%) and static handgrip exercise (SHG 30%). Nitric oxide levels increase during exercise and help prevent excessive hypertension by both increasing vasodilation and reducing sympathetic nerve activity (SNA). Therefore, we hypothesized that tetrahydrobiopterin (BH4), an essential cofactor for nitric oxide synthase, would ameliorate the exaggerated exercise pressor response in CKD patients. In a randomized, double-blinded, placebo-controlled trial, we tested the effects of 12 wk of sapropterin dihydrochloride (6 R-BH4; n = 18) versus placebo ( n = 14) treatement on BP and muscle SNA (MSNA) responses during RHG 20% and SHG 30% in CKD patients. The 6 R-BH4-treated group had a significantly lower systolic BP (+6 ± 1 vs. +13 ± 2 mmHg, P = 0.002) and mean arterial pressure response (+5 ± 1 vs. +10 ± 2 mmHg, P = 0.020) during RHG 20% and a significantly lower systolic BP response (+19 ± 3 vs. +28 ± 3 mmHg, P = 0.043) during SHG 30%. Under baseline conditions, there was no significant difference in MSNA responses between the groups; however, when the BP response during exercise was equalized between the groups using nitroprusside, the 6 R-BH4-treated group had a significantly lower MSNA response during RHG 20% (6R-BH4 vs. placebo, +12 ± 1 vs. +21 ± 2 bursts/min, P = 0.004) but not during SHG 30%. These findings suggest that 6 R-BH4 ameliorates the augmented BP response during RHG 20% and SHG 30% in CKD patients. A reduction in reflex activation of SNA may contribute to the decreased exercise pressor response during RHG 20% but not during SHG 30% in CKD patients.

scholarly journals Effect of low-dose lidocaine on objective upper extremity strength and immediate pain relief following cervical interlaminar epidural injections: a double-blinded randomized controlled trial

2020 ◽  
Vol 45 (10) ◽  
pp. 767-773
Author(s):  
Zachary L. McCormick ◽  
Taylor Burnham ◽  
Shellie Cunningham ◽  
Richard W Kendall ◽  
David Bougie ◽  
...  
Keyword(s):  
Pain Relief ◽  
Upper Extremity ◽  
Low Dose ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Radicular Pain ◽  
Spinal Block ◽  
Epidural Injections ◽  
Significant Difference ◽  
Double Blinded

BackgroundLow-dose lidocaine is a common diluent for analgesia following cervical interlaminar epidural steroid injection (CIESI). Concerns with this practice exist. A single-arm cohort reported that 20% of patients develop postprocedural upper extremity weakness when using lidocaine as a diluent. Furthermore, a high-cervical spinal block with unintended intrathecal or subdural administration is possible.ObjectiveDetermine if low-dose lidocaine as a diluent during CIESI causes clinically meaningful (1) upper extremity weakness and (2) immediate pain relief when compared with saline.DesignDouble-blinded randomized control trial.MethodsPatients with cervical radicular pain scheduled for CIESI were enrolled. Participants received lidocaine (CIESI-L) or saline (CIESI-S) as a diluent for the epidural injectate. Myotomal strength was measured with dynamometry before and between 20 and 30 min after CIESI. Pre-pain and post-pain scores were obtained. Primary and secondary outcomes were post-CIESI weakness of ≥20% (minimal clinically important difference (MCID)) in >1 myotome and ≥50% pain reduction on the numerical scale.Results120 participants (64 females (53%), mean age, 56 (SD 13.7) years) completed the study and were analyzed (CIESI-L n=60; CIESI-S n=60). There was no significant between-group difference in the proportion of participants with postprocedural weakness, CIESI-L 41.7% (95% CI, 29.8% to 54.5%), CIESL-S 50% (95% CI, 37.5% to 62.5%). Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).ConclusionLow-dose lidocaine as a diluent in CIESI does not significantly increase the risk of post-CIESI myotomal weakness when compared with saline, but also does not substantially increase the likelihood of immediate, meaningful pain relief.Trial registration detailsClinicalTrials.gov (NCT03127137); December 26, 2017.

Internet-Based Self-Help Training for Children and Adolescents with Recurrent Headache: A Pilot Study

2008 ◽  
Vol 36 (2) ◽  
pp. 241-245 ◽  
Author(s):  
Ellen Trautmann ◽  
Birgit Kröner-Herwig
Keyword(s):  
Therapeutic Potential ◽  
Pain Catastrophizing ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Post Treatment ◽  
The Internet ◽  
Behavioural Treatment ◽  
Self Help ◽  
Cognitive Behavioural

AbstractWe report the results of a randomized controlled trial that compared the efficacy of an internet-based self-help treatment for paediatric headache including chat communication (cognitive-behavioural treatment, CBT) with an internet-based psychoeducation intervention (EDU). In the CBT group, significant pre- to post-treatment decreases were found for headache frequency and pain catastrophizing, but not for headache intensity or duration. In the EDU group none of the variables (frequency, intensity, duration, pain catastrophizing) showed improvement. No significant between group differences were found for headache variables and pain catastrophizing at post-treatment. The patients reported high satisfaction with the internet-based training and a good patient-trainer-alliance. Results were maintained at 6-month follow-up. Due to the small sample size, no general conclusions can be drawn regarding the efficacy of the internet-based training regarding the outcome variables, but the training was well accepted by patients. Further research is necessary to evaluate the therapeutic potential of such interventions.

scholarly journals INTRAARTICULAR EPSILON AMINOCAPROIC ACID VERSUS TRANEXAMIC ACID IN TOTAL KNEE ARTHROPLASTY

2021 ◽  
Vol 29 (6) ◽  
pp. 312-315
Author(s):  
JOAO PAULO FERNANDES GUERREIRO ◽  
JOSE RODOLFO MARTINES BALBINO ◽  
BRUNO POSSANI RODRIGUES ◽  
MARCUS VINICIUS DANIELI ◽  
ALEXANDRE OLIVEIRA QUEIROZ ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Tranexamic Acid ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Aminocaproic Acid ◽  
Osteoarthritis Of The Knee ◽  
Significant Difference ◽  
Total Knee ◽  
Double Blinded ◽  
Epsilon Aminocaproic Acid

ABSTRACT Objective: To examine and compare the clinical efficacy of intraarticular epsilon aminocaproic acid (EACA) and tranexamic acid (TXA) in total knee arthroplasty (TKA). Methods: This study was a prospective, single-center, double-blinded randomized controlled trial, including sixty patients with osteoarthritis of the knee divided into two groups of 30 patients. In the TXA group, 1 g of TXA (0.05 g/ml) was applied intraarticularly, and in the EACA group, 4 g of EACA (0.2 g/ml) was applied intraarticularly. Serum hemoglobin (Hgb) and hematocrit (Htb) were measured during the preoperatively and 24 and 48 hours postoperatively. The range of motion and pain were evaluated by clinical examination. To evaluate knee function before and 2 months after surgery, the Western Ontario and McMaster Universities Index (WOMAC) questionnaire was used. Results: In total, 56 (93.3%) patients were evaluated up to the second postoperative month. No significant difference between the groups (p > 0.05) was found in the decrease in Hgb or Htb at 24 or 48 hours. Regarding assessment of the pain, WOMAC score and gain in knee flexion, no significant advantages up to 60 days after surgery (p > 0.05) were found. Conclusions: The decrease in Hgb and Htb during the first 48 hours postoperatively and the risk of transfusion were similar with the intraarticular use of 1 g of TXA and 4 g of EACA in TKA. The possible benefits regarding knee pain, gain in flexion and function were also similar for the two drugs. Level of Evidence II, Randomized, Double-Blinded, Single-Centre, Prospective Clinical Trial.

scholarly journals Fusion and Opioid-Sparing With the Use of Ketorolac in Posterior Thoracolumbar Spinal Fusions: A Prospective Double-Blinded Randomized Placebo-Controlled Trial

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Evan J Lytle ◽  
Chad F Claus ◽  
Doris Tong ◽  
Diana Sigler R.Ph ◽  
Dominick Lago ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Perioperative Complications ◽  
Controlled Trial ◽  
Univariate Analysis ◽  
Opioid Use ◽  
Allocation Mechanism ◽  
Opioid Sparing ◽  
Analgesic Regimen ◽  
Significant Difference ◽  
Double Blinded

Abstract INTRODUCTION Use of Ketorolac in spinal fusion is limited due to the risk of pseudarthrosis. Recent literature suggested that such an effect could be type and dose-related. We sought to demonstrate that Ketorolac use was safe with significant opioid-sparing effect and non-inferior fusion rate. METHODS This is a prospective, double-blinded, randomized placebo-controlled trial designed according to the 2013 SPIRIT Guidelines. It is a 2-arm parallel design with a 1:1 randomization. Over a 2- period under 6 surgeons at 2 sites, consecutive patients who underwent elective 1 to 3 level minimally invasive thoracolumbar fusion were screened for inclusion/exclusion. Patients with fusion confounders were excluded. A centralized treatment allocation mechanism and Excel-generated block randomization were used. Patients received a 48-hr scheduled treatment of intravenous Ketorolac (15 mg IV Q6H) or saline. We implemented a standardized analgesia regimen using a standardized order set. The primary outcome was fusion as evaluated XR/CT using the Suk criteria at 6/12 mo by a blinded neuroradiologist. The secondary outcomes were morphine-equivalence (MME) in the first 48 hr postop and during the hospital stay, NSAIDs-specific perioperative complications, VAS, length of stay, and quality-of-life outcomes at 6/12 mo. Univariate analysis was used, P < .05 considered significant. The sample size was estimated to be 600. This is an interim analysis to evaluate the safety and MME reduction. RESULTS A total of 142 patients were analyzed. Patient characteristics and operative data were comparable between the groups except EBL. No significant difference in fusion was found at 6-mo. There was a significant reduction in total/48-hr MME and length of stay (LOS) for the ketorolac group. The only complication was a superficial hematoma in a ketorolac-assigned patient requiring evacuation. CONCLUSION Ketorolac demonstrated safety, a significant reduction in postoperative opioid use and length of stay when used as part of a multi-modal analgesic regimen after thoracolumbar fusion.

scholarly journals DrillCutTM vs. VersaCutTM prostate tissue morcellation devices after holmium laser enucleation: A prospective, randomized controlled trial

2018 ◽  
Vol 13 (8) ◽  
Author(s):  
Ahmed Ibrahim ◽  
Mostafa M. Elhilali ◽  
Mohammed A. Elkoushy ◽  
Sero Andonian ◽  
Serge Carrier
Keyword(s):  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Holmium Laser ◽  
Complication Rates ◽  
Symptomatic Benign Prostatic Hyperplasia ◽  
Significant Difference ◽  
Ethical Approval ◽  
Laser Enucleation ◽  
Holmium Laser Enucleation

Introduction: We aimed to compare efficacy, safety, and cost of disposables of the DrillCutTM morcellator with the VersaCutTM morcellator after holmium laser enucleation of the prostate (HoLEP).Methods: After obtaining ethical approval, consecutive patients undergoing HoLEP for symptomatic benign prostatic hyperplasia were randomized to have their enucleated prostates morcellated by either Karl Storz® DrillCutTM or Lumenis® VersaCutTM morcellators. All procedures were performed by two experienced urologists. Patients’ demographics and perioperative data were recorded. Both morcellators were compared for their safety, efficacy, and cost-effectiveness.Results: Eighty-two patients were included in the study (41 per each arm). Both groups were comparable in terms of age, preoperative prostate size (114 vs. 112 mL; p>0.05), enucleation time (95.3 vs. 91.7 minutes; p>0.05), and morcellation time (22.6 vs. 17.3 minutes; p>0.05). The DrillCutTM was associated with significantly lower morcellation rate when compared with the VersaCutTM(3.6 vs. 4.9 g/min; p= 0.03). In terms of safety, there was no significant difference between both morcellators in complication rates (2.4% vs. 7.3 %; p=0.1). However, there was one case of bladder perforation requiring exploration with the VersaCutTM. The DrillCutTM was associated with significantly higher cost of disposables when compared with the VersaCutTM ($247.5 vs. $160.9; p<0.01).Conclusions: Despite the small sample size, the DrillCutTM was associated with lower morcellation rate when compared with the VersaCutTM. However, this difference may not be clinically significant. Although both morcellators were comparable in their safety, the DrillCutTM was associated with higher cost of disposables when compared with the VersaCutTM.

scholarly journals Therapeutic efficacy of erythropoietin alfa and erythropoietin beta in hemodialysis; a randomized controlled trial

2018 ◽  
Vol 8 (1) ◽  
pp. 44-49
Author(s):  
Hamid-Reza Omrani ◽  
Sima Golmohhamadi ◽  
Amir-Hossein Hashemian ◽  
Ali-Zaman Vaysmoradi ◽  
Roya Safari-Faramani
Keyword(s):  
Controlled Trial ◽  
Hemoglobin Concentration ◽  
Control Group ◽  
Plasma Hemoglobin ◽  
Significant Difference ◽  
Erythropoietin Deficiency ◽  
Stage Renal Disease ◽  
Double Blinded ◽  
End Stage ◽  
Erythropoietin Alfa

Introduction: Anemia, as a common complication of end-stage renal disease (ESRD), usually develops due to erythropoietin deficiency. Recombinant human erythropoietins (rHEPOs) are indicated for the correction of renal anemia. Objectives: We aimed to evaluate the efficacy of a new brand of erythropoietin named CinnaPoietin (erythropoietin beta) on hemoglobin levels. Patients and Methods: This is a randomized double-blinded controlled trial. Ninety-six ESRD patients on hemodialysis recruited in the study, whose hemoglobin levels was less than 10 g/dL. They allocated to two groups. PDPoetin (erythropoietin alfa) 50-100 U/kg three times per week intravenously administrated to the control group and CinnaPoietin with exactly same regimen as like PDPoetin group administrated for the rest of the participants. The study duration was 3 months. We measured plasma hemoglobin monthly for 3 months. Results: We found, hemoglobin was increased across the time and it was statistically significant (P<0.001), while there was no statistically significant differences between the groups (P=0.712). Conclusion: According to the result of the present study there is no statistical significant difference between these two brands of exogenous rHEPO in the case of increasing the hemoglobin concentration.

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