scholarly journals The effect of triclosan-coated sutures on the rate of surgical site infection after hip and knee arthroplasty: a double-blind randomized controlled trial of 2546 patients

2018 ◽  
Vol 100-B (3) ◽  
pp. 296-302 ◽  
Author(s):  
A. P. Sprowson† ◽  
C. Jensen ◽  
N. Parsons ◽  
P. Partington ◽  
K. Emmerson ◽  
...  
Keyword(s):  
Surgical Site Infection ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Site Infection ◽  
Double Blind ◽  
Suture Group ◽  
Double Blinded ◽  
Complication Of Surgery

AimsSurgical site infection (SSI) is a common complication of surgery with an incidence of about 1% in the United Kingdom. Sutures can lead to the development of a SSI, as micro-organisms can colonize the suture as it is implanted. Triclosan-coated sutures, being antimicrobical, were developed to reduce the rate of SSI. Our aim was to assess whether triclosan-coated sutures cause a reduction in SSIs following arthroplasty of the hip and knee.Patients and MethodsThis two-arm, parallel, double-blinded study involved 2546 patients undergoing elective total hip (THA) and total knee arthroplasty (TKA) at three hospitals. A total of 1323 were quasi-randomized to a standard suture group, and 1223 being quasi-randomized to the triclosan-coated suture group. The primary endpoint was the rate of SSI at 30 days postoperatively.ResultsThe baseline characteristics of age, gender and comorbidities were well matched in the two groups. The rates of superficial SSI were 0.8% in the control group and 0.7% in the intervention group (p = 0.651), and when deep and superficial SSIs were combined the rates were 2.5% and 1.8 (p = 0.266). The length of stay in hospital and the rates of medical complications did not differ significantly between the groups (p = 1.000).ConclusionThis trial provided no evidence that the use of triclosan-coated sutures at THA and TKA leads to a reduction in the rate of SSI. Cite this article: Bone Joint J 2018;100-B:296–302.

scholarly journals Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

2021 ◽  
pp. 2100752
Author(s):  
Pradeesh Sivapalan ◽  
Charlotte Suppli Ulrik ◽  
Therese Sophie Lapperre ◽  
Rasmus Dahlin Bojesen ◽  
Josefin Eklöf ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Safety Outcome ◽  
Hospitalised Patients ◽  
Double Blinded ◽  
Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

scholarly journals The effectiveness of Kinesio Taping® for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial

2020 ◽  
Vol 34 (7) ◽  
pp. 877-889 ◽  
Author(s):  
Venta Donec ◽  
Raimondas Kubilius
Keyword(s):  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Outpatient Rehabilitation ◽  
Control Group ◽  
Double Blind ◽  
Kinesio Taping ◽  
Patient Reported ◽  
Double Blinded

Objective: To evaluate the effectiveness of the Kinesio Taping® method for mobility and functioning improvement for patients with knee osteoarthritis (KO). Design: Randomized, double-blinded, controlled trial. Setting: Outpatient rehabilitation department. Subjects: A total of 187 subjects with symptomatic I–III grade KO participated; of these, 157 subjects were included in the analyses (intervention group, n = 81 (123 knees); control group, n = 76 (114 knees). Intervention: The intervention group received a specific Kinesio Taping application, and the control group received non-specific knee taping for a month. Main measures: Changes in Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST) were assessed at baseline, after four weeks of taping, and a month post taping intervention. Subjective participants’ experiences and opinions on the effect of knee taping were evaluated. The chosen level of significance was p < 0.05. Results: The mean age of participants was 68.7 ± 9.9 in intervention group and 70.6 ± 8.3 in control group ( p > 0.05). The change from baseline in gait speed in the intervention group after taping month was +0.04 ± 0.1 m/s, at follow-up +0.06 ± 0.1 m/s; in control group +0.07 ± 0.1 m/s, and +0.09 ± 0.1 m/s; the change in time needed to accomplish 5xSST was –2.2 ± 3.2 seconds, at follow-up –2.4 ± 3.1 seconds; in control group –2.8 ± 3.6 seconds, and –2.4 ± 4 seconds. Improved knee flexion and enhancement in functioning assessed by KOOS were noticed in both groups, with lasting improvement to follow up. No difference in the change in the above-mentioned outcomes was found between groups ( p > 0.05). Fewer subjects (6.2% (5) vs. 21.1% (16), χ2 = 7.5, df = 2, p = 0.024) from Kinesio Taping group were unsure if taping alleviated their mobility and more intervention group patients indicated higher subjective satisfaction with the effect of knee taping to symptom and mobility alleviation than control group ( p < 0.005). Conclusion: Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.

scholarly journals Dexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yuan Zhang ◽  
Di Bao ◽  
Dongmei Chi ◽  
Lu Li ◽  
Bin Liu ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Postoperative Analgesia ◽  
Pediatric Patients ◽  
Pediatric Population ◽  
Controlled Trial ◽  
Intervention Group ◽  
Saline Control ◽  
Control Group ◽  
Double Blind ◽  
Double Blinded

Abstract Background Postoperative pain is a common problem that occurs in pediatric patients following neurosurgery which may lead to severe complications. Dexmedetomidine is a commonly used adjuvant medicine in craniotomy owing to its sedative, amnestic, analgesic, and neuroprotective properties. Besides, studies suggest that lidocaine has similar effects on sedation, analgesia, and neuroprotection. Both two adjuvants can reduce postoperative pain after neurosurgery in adults. However, it is still unknown whether dexmedetomidine or lidocaine can reduce postoperative pain in children undergoing craniotomy, and if yes, which is a better medicine choice. Therefore, we aimed to compare the effect of dexmedetomidine vs. lidocaine on postoperative pain in pediatric patients after craniotomy. Methods/design We will perform a randomized (1:1:1), double-blind, placebo-controlled, single-center trial. Children aged 1–12 years scheduled for craniotomy will be eligible for inclusion. The 255 recruited participants will be stratified by age in two strata (1–6 years and 7–12 years), and then each stratum will be equally randomized to three groups: group D (infusion of dexmedetomidine [intervention group]), group L (infusion of lidocaine [intervention group]), and group C (infusion of normal saline [control group]). Patients will be followed up at 1 h, 2 h, 4 h, 24 h, and 48 h after surgery. The primary outcome will be total sufentanil consumption within 24 h after surgery. Discussion In this clinical trial, we expect to clarify and compare the postoperative analgesic effect of dexmedetomidine vs. lidocaine infusion on pediatric patients undergoing craniotomy. We believe that the results of this trial will provide more choices for postoperative analgesia for the pediatric population. Trial registration Chinese ClinicalTrials.gov ChiCTR1800019411. Registered on 10 November 2018

scholarly journals Dexmedetomidine Versus Lidocaine for Postoperative Analgesia in Pediatric Patients Undergoing Craniotomy: a Protocol for a Prospective, Randomized, Double-blinded, Placebo-controlled Trial

2021 ◽  
Author(s):  
Yuan Zhang ◽  
Di Bao ◽  
Dongmei Chi ◽  
Lu Li ◽  
Bin Liu ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Postoperative Analgesia ◽  
Pediatric Patients ◽  
Pediatric Population ◽  
Controlled Trial ◽  
Intervention Group ◽  
Saline Control ◽  
Control Group ◽  
Double Blind ◽  
Double Blinded

Abstract Background: Postoperative pain is a common problem that occurs in pediatric patients following neurosurgery which may lead to severe complications. Dexmedetomidine is a commonly used adjuvant medicine in craniotomy owing to its sedative, amnestic, analgesic, and neuroprotective properties. Besides, studies suggest that lidocaine has similar effects on sedation, analgesia, and neuroprotection. Both two adjuvants can reduce postoperative pain after neurosurgery in adults. However, it is still unknown whether dexmedetomidine or lidocaine can reduce postoperative pain in children undergoing craniotomy and if yes, which is a better medicine choice. Therefore, we aimed to compare the effect of dexmedetomidine vs. lidocaine on postoperative pain in pediatric patients after craniotomy. Methods/design: We will perform a randomized (1:1:1), double-blind, placebo-controlled, single-center trial. Children aged 1–12 years scheduled for craniotomy will be eligible for inclusion. The 255 recruited participants will be stratified by age in two strata (1–6 years and 7–12 years), and then each stratum will be equally randomized to three groups: Group D (infusion of dexmedetomidine [intervention group]), Group L (infusion of lidocaine [intervention group]), and Group C (infusion of normal saline [control group]). Patients will be followed-up at 1 h, 2 h, 4 h, 24 h, and 48 h after surgery. The primary outcome will be total sufentanil consumption within 24 h after surgery.Discussion: In this clinical trial, we expect to clarify and compare the postoperative analgesic effect of dexmedetomidine vs. lidocaine infusion on pediatric patients undergoing craniotomy. We believe that the results of this trial will provide more choices for postoperative analgesia for the pediatric population.Trial registration: Chinese ClinicalTrials.gov Identifier: ChiCTR1800019411. Registered 10 November 2018. Registered with the name of “A randomized double-blind controlled trial for low-dose dexmedetomidine and lidocaine in the treatment of post-craniotomy pain in children” URL: http://www.chictr.org.cn/showproj.aspx?proj=32822

scholarly journals Effect of a single preoperative dose of oral antibiotic to reduce the incidence of surgical site infection following below-knee dermatological flap and graft repair

2019 ◽  
pp. 28-35 ◽  
Author(s):  
Helena Rosengren ◽  
Clare Heal ◽  
Petra Buettner
Keyword(s):  
Surgical Site Infection ◽  
Antibiotic Prophylaxis ◽  
Controlled Trial ◽  
Study Groups ◽  
High Dose ◽  
Antibiotic Administration ◽  
Oral Antibiotic ◽  
Site Infection ◽  
Double Blind

Background: Surgical site infection (SSI) rates for below-knee dermatological surgery are unacceptably high, particularly following complex flap and graft closures. The role of antibiotic prophylaxis for these surgical cases is uncertain. Objective: To determine whether SSI following complex dermatological closures on the leg could be reduced by antibiotic prophylaxis administered as a single oral preoperative dose. Methods: A total of 115 participants were randomized to 2 g of oral cephalexin or placebo 40-60 minutes prior to surgical incision in a prospective, randomized, double-blind, placebo-controlled trial at a primary care skin cancer clinic in North Queensland, Australia. Results: Overall 17/55 (30.9%) controls and 14/55 (25.5%) intervention participants developed infection (P = 0.525). There was no difference between the study groups in adverse symptoms that could be attributed to high-dose antibiotic administration (P = 1).

scholarly journals Effect of Oral Ingestion of Low-Molecular Collagen Peptides Derived from Skate (Raja Kenojei) Skin on Body Fat in Overweight Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Marine Drugs ◽  
2019 ◽  
Vol 17 (3) ◽  
pp. 157 ◽  
Author(s):  
Young Tak ◽  
Yun Kim ◽  
Jeong Lee ◽  
Yu-Hyun Yi ◽  
Young Cho ◽  
...  
Keyword(s):  
Body Fat ◽  
Animal Studies ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Collagen Peptides ◽  
Collagen Peptide ◽  
Skin Collagen ◽  
Overweight Adults

Recent animal studies found the potential of a collagen peptide derived from skate skin to have anti-obesity effects through the suppression of fat accumulation and regulation of lipid metabolism. However, no studies have yet been performed in humans. Here, this very first human randomized, placebo-controlled, and double-blinded study was designed to investigate the efficacy and tolerability of skate skin collagen peptides (SCP) for the reduction of body fat in overweight adults. Ninety healthy volunteers (17 men) aged 41.2 ± 10.4 years with a mean body mass index of 25.6 ± 1.9 kg/m2 were assigned to the intervention group (IG), which received 2000 mg of SCP per day or to the control group (CG) given the placebo for 12 weeks and 81 (90%) participants completed the study. Changes in body fat were evaluated using dual energy X-ray absorptiometry as a primary efficacy endpoint. After 12 weeks of the trial, the percentage of body fat and body fat mass (kg) in IG were found to be significantly better than those of subjects in CG (−1.2% vs. 2.7%, p = 0.024 and −1.2 kg vs. 0.3 kg, p = 0.025). Application of SCP was well tolerated and no notable adverse effect was reported from both groups. These results suggest the beneficial potential of SCP in the reduction of body fat in overweight adults.

scholarly journals Local Efficacy of Corticosteroids as an Adjuvant for Periarticular Cocktail Injection in Simultaneous Bilateral Total Knee Arthroplasty: A Prospective Randomized Double-blind Controlled Trial

2020 ◽  
Author(s):  
huiming peng ◽  
wei wang ◽  
jin lin ◽  
xisheng weng ◽  
wenwei qian ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Visual Analog Scale ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Visual Analog Scale Score ◽  
Analog Scale ◽  
Double Blind ◽  
Total Knee ◽  
Double Blinded ◽  
Hss Score

Abstract Background: Multimodal cocktail periarticular injection(MCPI) including corticosteroids is currently widely applied to reduce postoperative pain and swelling following total knee arthroplasty (TKA). However the addition of steroids is controversial.This prospective, double-blinded, randomized, controlled trial compares the safety and efficacy of MCPI with or without corticosteroids.Methods: A total of 60 patients (120 knees) who underwent simultaneous bilateral TKAs received periarticular injections with added betamethasone (7mg) in a randomly selected knee, and the other knee was injected without added corticosteroids. The visual analog scale(VAS) pain scores at rest and in motion, range of motion (ROM), thigh swelling, hospital for special surgery(HSS) score, and adverse events were compared between the 2 knees.Results: There were no statistically significant differences in the visual analog scale score, ROM, thigh girth, HSS score, and complications between the 2 kness. The patients were unable to detect a difference in the functional recovery between their knees on postoperative day 3or at the 3 month follow-up.Conclusion: Betamethasone injections are ineffective locally for relieving pain, reducing swelling, and improving the postoperative ROM.Trial registration: Chinese Clinical Trial RegistryNumber: ChiCTR-OPC-17013503, Date of Registration: 2017-11-23 URL:http://www.chictr.org.cn/showproj.aspx?proj=23146

scholarly journals Consumption of melatonin supplement improves cardiovascular disease risk factors and anthropometric indices in type 2 diabetes mellitus patients: A double-blind, randomized, placebo-controlled trial

2020 ◽  
Author(s):  
Hadi Bazyar ◽  
Ahmad Zare Javid ◽  
Hossein Bavi Behbahani ◽  
Fardin Moradi ◽  
Bahman Moradi Poode ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Disease Risk ◽  
Controlled Trial ◽  
Cardiovascular Disease Risk ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Anthropometric Indices ◽  
Double Blind ◽  
Conicity Index

Abstract Background: Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications that may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled. This study investigated the effects of melatonin supplementation on some cardiovascular disease risk factors and anthropometric indices in patients with type 2 diabetes mellitus (T2DM).Materials and Methods: In this double-blind, randomized, placebo-controlled trial, 50 T2DM patients were randomly allocated to intervention and control groups which received two tablets of either melatonin or placebo (250 mg) once a day for eight weeks. Mean arterial pressure (MAP), pulse pressure (PP), the atherogenic index of plasma (AIP), weight, body mass index (BMI), waist and hip circumference (WC, HC), body shape index (ABSI), abdominal volume index (AVI), body adiposity index (BAI), lipid accumulation product (LAP), conicity index, and waist-to-height ratio (WHR) were evaluated in all the patients pre- and post-intervention.Results: Melatonin supplementation for eight weeks significantly decreased the mean levels of MAP, PP, weight, BMI, WC, HC, BAI, AVI, conicity index, and WHR post-intervention (p<0.05). Also, the median changes of MAP, PP, weight, BMI, WC, HC BAI, AVI, and conicity index were significantly lower in the intervention group compared with the control group (p<0.05). A significant increase (p<0.001) was observed in the mean levels of ABSI in the intervention group. The median changes of ABSI were significantly greater in the intervention group compared with the control group (p<0.001).Conclusions: Consumption of melatonin supplement may be effective in controlling arterial pressure and anthropometric indices (as predictors of obesity) in T2DM patients.Trial registration: This trial was registered in the Iranian Registry of Clinical Trials website at 2019/5/17. (IRCT20190303042905N1).

scholarly journals PERBANDINGAN ANTARA PEMBERIAN ANTIBIOTIKA PROFILAKSIS PADA SEKSIO SESAR SESUAI ALUR KLINIS RSUP DR SARDJITO DENGAN ANTIBIOTIKA DOSIS MULTIPEL TERHADAP KEJADIAN INFEKSI LUKA OPERASI

2016 ◽  
Vol 3 (2) ◽  
pp. 75
Author(s):  
Ardian Rahmansyah ◽  
Mohammad Hakimi ◽  
Rukmono Siswishanto
Keyword(s):  
Length Of Stay ◽  
Cesarean Section ◽  
Surgical Site Infection ◽  
Clinical Pathway ◽  
Intervention Group ◽  
Group Versus ◽  
Control Group ◽  
Site Infection ◽  
Short Term

Background: Clinical pathway recommend the use of short-term prophylaxis antibiotics for cesarean section. Long-term antibiotics or multiple doses was found in clinical practice. There are differences in the mode of administration and the number of doses administered at sardjito hospital.Objective: To determine the effectiveness of short-term antibiotic prophylaxis in cesarean section appropriate to clinical pathway in the prevention of surgical site infection (ssi), the incidence of fever, dysuria events, length of stay.Method: The study used randomized clinical trial. The study subjects who underwent cesarean section and meet the inclusion and exclusion criteria in the period July 2013 to January 2014 divided into an intervention group (n = 52) who received ampicillin 2 gram pre and post-cesarean section, and a control group (n = 54) who received ampicillin 2 gram pre cesarean section and 1 gram every 8 hours for 6 times. Observed on days 3 and 10 post-cesarean section. The primary outcomes assessed were the incidence of surgical wound infection based on the criteria of surgical site infection from Centers for Disease Controland Prevention. Secondary outcomes assessed were the incidence of fever, dysuria events, length of stay. Homogeneity analysis were conducted on subject. Outcome analysis performed bivariate with t test and chi squared test.Results and Discussion : A total of 106 subjects can be analyzed. SSI events in the intervention group at day 3 was 3.8% (n = 52) and control group was 1.84% (n = 54) with p>0.05 RR 2.077 (95% CI 0.194 to 22.219). SSI on day 10 of 7.7% (n = 52) in the intervention group versus 9.3% (n = 54) in controls with p<0.05 RR 0.831 (CI 95%, 0.236 to 2.924). Fever events on day 3 by 5.8% in the intervention group versus 3.7% incontrols with p>0.05 RR 1.558 (95% CI 0.271 to 8.948) and on day 10 was 3.8% versus 3.7 % with p>0.05 RR 1.038 (95% CI 0.152 to 7.102). Dysuria not found on day 3 and but on 10 found 5.8% in the intervention group versus 11.1% with p>0.05 RR 0.519 (IK95% 0.137 to 1.968). Length of stay after cesarean section for 3.21 ± 0.412 days in the intervention group and 3.26 ± 0.442 days in the control group with p>0.05 (95% CI -0.213 - 0.117).Conclusion: There is no significant difference in the incidence of surgical wound infections, the incidence of fever, dysuria, length of stay between short-term prophylaxis antibiotics ampicillin appropriate to clinical pathway and long-term or multiple doses prophylaxis antibiotics. Short term antibiotics prophylaxis are more efficiently with the same effectiveness in preventing outcomes research.Keywords: prophylaxis antibiotics, ampicillin, short term regimen, long term regimen, cesarean section, surgical site infection. 

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