scholarly journals Aqueous chlorhexidine 1% versus 2% for neonatal skin antisepsis: a randomised non-inferiority trial

2021 ◽  
pp. fetalneonatal-2020-321174
Author(s):  
Akash Sharma ◽  
Srikant Kulkarni ◽  
Anu Thukral ◽  
M Jeeva Sankar ◽  
Ramesh Agarwal ◽  
...  
Keyword(s):  
Neonatal Intensive Care ◽  
Randomised Trial ◽  
Risk Difference ◽  
Chlorhexidine Gluconate ◽  
Skin Reactions ◽  
Local Skin ◽  
Significant Difference ◽  
Median Plasma ◽  
Skin Antisepsis ◽  
Neonatal Skin

ObjectiveTo evaluate whether 1% aqueous chlorhexidine gluconate (CHG) when compared with 2% aqueous chlorhexidine gluconate is non-inferior for neonatal skin antisepsis.DesignParallel, blinded, non-inferiority randomised trial.SettingLevel III, academic, neonatal intensive care unit.PatientsInfants born at 260/7 to 426/7 weeks of gestation from June 2019 to December 2019.InterventionsParticipants were randomised to skin antisepsis by either 1% aqueous CHG or 2% aqueous CHG.Main outcome measuresThe primary outcome was the proportion of negative skin swab cultures after skin antisepsis. Secondary outcomes were local skin reactions at 0, 6, 12 and 24 hours and plasma chlorhexidine levels in a subset of the study population.ResultsA total of 308 neonates with a median gestation age of 34 (31–37) weeks and mean birth weight of 2029 g were randomised on 685 occasions (1% CHG: n=341; 2% CHG: n=344). 93.0% of the post-antisepsis skin swabs were sterile in 1% CHG group compared with 95.6% of the swabs in the 2% CHG group (risk difference −2.7%, 95% CI −6.2% to +0.8%). The lower bound of 95% CI crossed the pre-specified absolute non-inferiority limit of 5%. Neonates developed mild dermatitis on 16 (2.3%) occasions. There was no significant difference in median plasma CHG levels in the two groups, 19.6 (12.5–36.4) and 12.6 (8.7–26.6) ng/mL, respectively.ConclusionsApplication of 1% aqueous CHG was not shown to be non-inferior to 2% chlorhexidine aqueous for skin antisepsis in neonates. There were no severe skin-related adverse events in either of the two groups.Trial registration numberCTRI/2019/06/019822; (http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=33453&EncHid=&userName=CTRI/2019/06/019822)

scholarly journals Preoperative skin antisepsis with chlorhexidine gluconate versus povidone-iodine: a prospective analysis of 6959 consecutive spinal surgery patients

2018 ◽  
Vol 28 (2) ◽  
pp. 209-214 ◽  
Author(s):  
George M. Ghobrial ◽  
Michael Y. Wang ◽  
Barth A. Green ◽  
Howard B. Levene ◽  
Glen Manzano ◽  
...  
Keyword(s):  
Spinal Surgery ◽  
Open Surgery ◽  
Isopropyl Alcohol ◽  
Povidone Iodine ◽  
Chlorhexidine Gluconate ◽  
Iodine Solution ◽  
Significant Difference ◽  
Skin Antisepsis ◽  
Consecutive Time ◽  
Povidone Iodine Solution

OBJECTIVEThe aim of this study was to determine the efficacy of 2 common preoperative surgical skin antiseptic agents, ChloraPrep and Betadine, in the reduction of postoperative surgical site infection (SSI) in spinal surgery procedures.METHODSTwo preoperative surgical skin antiseptic agents—ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol) and Betadine (7.5% povidone-iodine solution)—were prospectively compared across 2 consecutive time periods for all consecutive adult neurosurgical spine patients. The primary end point was the incidence of SSI.RESULTSA total of 6959 consecutive spinal surgery patients were identified from July 1, 2011, through August 31, 2015, with 4495 (64.6%) and 2464 (35.4%) patients treated at facilities 1 and 2, respectively. Sixty-nine (0.992%) SSIs were observed. There was no significant difference in the incidence of infection between patients prepared with Betadine (33 [1.036%] of 3185) and those prepared with ChloraPrep (36 [0.954%] of 3774; p = 0.728). Neither was there a significant difference in the incidence of infection in the patients treated at facility 1 (52 [1.157%] of 4495) versus facility 2 (17 [0.690%] of 2464; p = 0.06). Among the patients with SSI, the most common indication was degenerative disease (48 [69.6%] of 69). Fifty-one (74%) patients with SSI had undergone instrumented fusions in the index operation, and 38 (55%) patients with SSI had undergone revision surgeries. The incidence of SSI for minimally invasive and open surgery was 0.226% (2 of 885 cases) and 1.103% (67 of 6074 cases), respectively.CONCLUSIONSThe choice of either ChloraPrep or Betadine for preoperative skin antisepsis in spinal surgery had no significant impact on the incidence of postoperative SSI.

Neonatal Skin and Chlorhexidine: A Burning Experience

2013 ◽  
Vol 33 (1) ◽  
pp. 19-23 ◽  
Author(s):  
Jennifer Kutsch ◽  
Daniele Ottinger
Keyword(s):  
Case Report ◽  
Neonatal Intensive Care ◽  
Strong Association ◽  
Safety Data ◽  
Extremely Low Birth Weight ◽  
Neonatal Intensive Care Units ◽  
Skin Reactions ◽  
Line Placement ◽  
Skin Integrity ◽  
Neonatal Skin

Purpose: Despite the lack of safety data, chlorhexidine gluconate (CHG) is an antiseptic with broad-spectrum coverage often used in neonatal intensive care units (NICUs). Adverse skin reactions, most commonly burns, have been reported after the use of CHG. Preserving skin integrity in preterm infants is vital in the prevention of sepsis, excessive water loss, hypothermia, and renal failure.Design: This is a case report of two incidents of significant skin burning in extremely low birth weight (ELBW) infants who were treated with CHG for the purposes of umbilical cord sterilization prior to umbilical line placement.Sample: This case report of burns associated with CHG in one infant weighing 610 g at birth and a second infant weighing 600 g at birth.Results: CHG does have a strong association with causing skin burns in the ELBW population; however, wiping the solution off of the skin seems to reduce injury.

scholarly journals Randomised trial on clinical performances and biocompatibility of four high-flux hemodialyzers in two mode treatments: hemodialysis vs post dilution hemodiafiltration

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Marion Morena ◽  
Caroline Creput ◽  
Mouloud Bouzernidj ◽  
Annie Rodriguez ◽  
Lotfi Chalabi ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Randomised Trial ◽  
High Flux ◽  
Β2 Microglobulin ◽  
Inflammatory Parameters ◽  
Large Size ◽  
Significant Difference ◽  
Good Biocompatibility ◽  
Very High ◽  
Solute Clearance

AbstractThis prospective multicenter randomized comparative cross-over trial aimed at evaluating the influence of hemodialysis vs post-dilution hemodiafiltration with high-flux dialyzers in solute clearance and biocompatibility profile. 32 patients were sequentially dialyzed with Leoceed-21HX, Polypure-22S+, Rexsys-27H and VIE-21A. Primary outcome was β2-microglobulin removal. Secondary outcomes were (i) extraction of other uremic solutes (ii) parameters of inflammation and nutrition and (iii) comparative quantification of perdialytic albumin losses (using total ‘TDC’ vs partial ‘PDC’ collection of dialysate). Significant increases in removal rates of β2-microglobulin (84.7 ± 0.8 vs 71.6 ± 0.8 mg/L), myoglobin (65.9 ± 1.3 vs 38.6 ± 1.3 µg/L), free immunoglobulin light chains Kappa (74.9 ± 0.8 vs 55.6 ± 0.8 mg/L), β-trace protein (54.8 ± 1.3 vs 26.8 ± 1.4 mg/L) and orosomucoid (11.0 ± 1.1 vs 6.0 ± 1.1 g/L) but not myostatin (14.8 ± 1.5 vs 13.0 ± 1.5 ng/mL) were observed in HDF compared to HD when pooling all dialyzers. Rexsys and VIE-A use in both HD and HDF subgroups was associated to a better removal of middle/large-size molecules compared to Leoceed and Polypure, except β2-microglobulin for Rexsys. Inflammatory parameters were unchanged between dialyzers without any interaction with dialysis modality. Mean dialysate albumin loss was comparable between TDC and PDC (1.855 vs 1.826 g/session for TDC and PDC respectively). In addition, a significant difference in albumin loss was observed between dialyzers with the highest value (4.5 g/session) observed using Rexsys. Use of all dialyzers was associated with good removals of the large spectrum of uremic toxins tested and good biocompatibility profiles, with an additional gain in removal performances with HDF. Larger surface area, thinner wall and resultant very high ultrafiltration coefficient of Rexsys should be taken into account in its clear performance advantages.

The Effect of Individualized Developmental Care Practices in Preterm Infants

2019 ◽  
Vol 27 (2) ◽  
pp. 97-104
Author(s):  
Dilek Küçük Alemdar ◽  
Sevil İnal
Keyword(s):  
Breast Milk ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Oral Feeding ◽  
Control Group ◽  
Developmental Care ◽  
Significant Difference ◽  
Care Practices ◽  
Maternal Voice

Background: Preterm infants are vulnerable humans requiring much care and attention. They may be exposed to irregular noise, light, and odor in the neonatal intensive care unit for a period of several weeks or months. This study was carried out to determine the effect of individualized developmental care on physiological parameters, growth, and transition to oral feeding in preterm infants. Methods: The study was a randomized controlled trial. The sample comprised premature infants meeting the inclusion criteria. They were randomly assigned to four groups: the maternal voice group, the breast milk odor (BMO) group, the incubator cover (IC) group, and the control group. Results: No statistically significant difference was found between the groups in terms of weight, height, and head circumference at time of discharge. Mean SO2 values were statistically higher in the IC group than the other groups; however, the heart rate and respiratory rate were not statistically different in a significant sense between the groups. The briefest duration of transition to total oral feeding was seen in the BMO group. Conclusion: Individualized developmental care practices based on the results of these interventions are likely to support the care of preterm infants. Breast milk odor may ease the transition to breastfeeding.

Comparison of healthcare utilization and outcomes by gestational diabetes diagnostic criteria

2018 ◽  
Vol 46 (4) ◽  
pp. 401-409 ◽  
Author(s):  
Julianne R. Lauring ◽  
Allen R. Kunselman ◽  
Jaimey M. Pauli ◽  
John T. Repke ◽  
Serdar H. Ural
Keyword(s):  
Gestational Diabetes ◽  
Healthcare Utilization ◽  
Retrospective Cohort ◽  
Neonatal Intensive Care ◽  
Hospital Admissions ◽  
Neonatal Intensive Care Units ◽  
Maternal Healthcare ◽  
Number Of Patients ◽  
Significant Difference ◽  
Data Group

Abstract Objective: To compare healthcare utilization and outcomes using the Carpenter-Coustan (CC) criteria vs. the National Diabetes Data Group (NDDG) criteria for gestational diabetes mellitus (GDM). Methods: This is a retrospective cohort study. Prior to 8/21/2013, patients were classified as “GDM by CC” if they met criteria. After 8/21/2013, patients were classified as “GDM by NDDG” if they met criteria and “Meeting CC non-GDM” if they met CC, but failed to reach NDDG criteria. “Non-GDM” women did not meet any criteria for GDM. Records were reviewed after delivery. Results: There was a 41% reduction in GDM diagnosed using NDDG compared to CC (P=0.01). There was no significant difference in triage visits, ultrasounds for growth or hospital admissions. Women classified as “Meeting CC non-GDM” were more likely to have preeclampsia than “GDM by CC” women [OR 11.11 (2.7, 50.0), P=0.0006]. Newborns of mothers “Meeting CC non-GDM” were more likely to be admitted to neonatal intensive care units than “GDM by CC” [OR 6.25 (1.7, 33.3), P=0.006], “GDM by NDDG” [OR 5.56 (1.3, 33.3), P=0.018] and “Non-GDM” newborns [OR 6.47 (2.6, 14.8), P=0.0003]. Conclusion: Using the NDDG criteria may increase healthcare costs because while it decreases the number of patients being diagnosed with GDM, it may also increase maternal and neonatal complications without changing maternal healthcare utilization.

scholarly journals OP0288 ANTI-IL1 TREATMENT IN COLCHICINE RESISTANT PEDIATRIC FMF PATIENTS-REAL LIFE DATA FROM THE HELIOS REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 179.1-180
Author(s):  
E. Sag ◽  
F. Akal ◽  
E. Atalay ◽  
U. Kaya Akca ◽  
S. Demir ◽  
...  
Keyword(s):  
Age At Onset ◽  
Real Life ◽  
First Line ◽  
Research Support ◽  
Skin Reactions ◽  
Local Skin ◽  
Extreme Stress ◽  
On Demand ◽  
Drug Registry ◽  
Treatment Onset

Background:FMF is a prototype of autoinflammatory diseases associated with excess IL1 production. Anti-IL1 treatments are the first-line alternatives in colchicine resistant/intolerant FMF patients.Objectives:We aimed to investigate the efficacy and safety of anti-IL1 treatment in pediatric FMF patients in our local (HELIOS) registry.Methods:HELIOS (Hacettepe univErsity eLectronIc research fOrmS) is a web-based biological drug registry for pediatric rheumatology patients (helios.hacettepe.edu.tr). Data were recorded at biological treatment onset (month 0), at month 6 and yearly thereafter in patients. We have analysed the clinical features, disease activity parameters, treatment responses and safety outcomes in FMF patients treated with anti-IL1 agent.Results:Forty pediatric FMF patients were included to the study group (67% female).Thirty-four patients received continous anti-IL1 treatment. The mean age at the start of the colchicine was 5.55±3.87 years. Age at onset of the anti-IL1 treatment was 11.47±5.41 with a mean follow-up duration of 3.87±1.96 years. Apart from two patients, all of them had biallelic exon-10 mutations.We have also given anti-IL1 treatment on an on-demand basis in six adolescent patients. Five of them were having very severe attacks during menstrual periods and one was having attacks during extreme stress periods along with very high CRP levels. The quality of life has markedly improved and these patients no longer reveal any CRP elevation.Anakinra was used as the first-line anti-IL1 treatment. During the last visit, six patients were treated with anakinra and 28 patients were treated with canakinumab. Anti-IL1 treatment decreased the CRP levels, number and severity of the attacks. (Figure 1.) There were three hospitalizations reported due to mild infections. Eleven patients had local skin reactions, two patients had leukopenia with anakinra and one patient had thrombocytopenia with canakinumab. We have discontinued anti-IL1 treatment until the cytopenia subsided. We have switched to on-demand therapy in one patient, started the same treatment and gradually increased the dose in the other two patients. There were no malignancy or other severe adverse reactions.Figure 1.Conclusion:Anakinra and canakinumab are efficient and safe alternatives in colchicine resistant and intolerant pediatric FMF patients. We also for the first time, report on-demand use of anti-IL1 in pediatric FMF patients. We suggest that on-demand treatment should be considered under certain circumstances where the trigger is known and short-lasting (such as menstruation and periods of extreme stress)Acknowledgments:Authors would like to thank Elif Arslanoglu Aydin, Armagan Keskin, Kubra Yuksel and Emil Aliyev for their contribution to the HELIOS registryDisclosure of Interests:Erdal Sag Grant/research support from: Novartis and SOBI financially supported the HELIOS registry during the establishment of infrastructure, Fuat Akal Grant/research support from: Novartis and SOBI financially supported the HELIOS registry during the establishment of infrastructure, Erdal Atalay Grant/research support from: Novartis and SOBI financially supported the HELIOS registry during the establishment of infrastructure, Ummusen Kaya Akca Grant/research support from: Novartis and SOBI financially supported the HELIOS registry during the establishment of infrastructure, Selcan Demir Grant/research support from: Novartis and SOBI financially supported the HELIOS registry during the establishment of infrastructure, Dilara Demirel Grant/research support from: Novartis and SOBI financially supported the HELIOS registry during the establishment of infrastructure, Ezgi Deniz Batu Grant/research support from: Novartis and SOBI financially supported the HELIOS registry during the establishment of infrastructure, Yelda Bilginer Grant/research support from: Novartis and SOBI financially supported the HELIOS registry during the establishment of infrastructure, Seza Özen Consultant of: Novartis, Pfizer, Speakers bureau: SOBI, Novartis

Sibling Visiting in a Neonatal Intensive Care Unit

PEDIATRICS ◽  
1983 ◽  
Vol 71 (5) ◽  
pp. 835-838
Author(s):  
Fred Schwab ◽  
Brenda Tolbert ◽  
Stephen Bagnato ◽  
M. Jeffrey Maisels
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Neonatal Intensive Care Unit ◽  
Direct Observation ◽  
Neonatal Intensive Care ◽  
Behavioral Patterns ◽  
Control Intervention ◽  
Significant Difference

The effect of sibling visiting in a neonatal intensive care unit was studied. Sixteen siblings of 13 infants were randomly assigned to a visiting or nonvisiting group. Behavioral patterns were measured by questionnaires administered to the parents and by direct observation and interviews with the children. There were no significant changes in the behavior of the children following the birth of their sibling, and there was no significant difference between the behavior scores of the two groups 1 week after the experimental (or control) intervention. The visiting children did not show signs of fear or anxiety during the visit. These data suggest that sibling visiting to a neonatal intensive care unit is not likely to be harmful and might be beneficial to the siblings and their families.

scholarly journals A Clinical Comparison of Atracurium and Vecuronium in Women Undergoing Laparoscopy

1987 ◽  
Vol 15 (3) ◽  
pp. 310-316 ◽  
Author(s):  
M. A. Raynes ◽  
R. Chisholm ◽  
D. F. Woolner ◽  
J. M. Gibbs
Keyword(s):  
Sinus Bradycardia ◽  
Neuromuscular Block ◽  
Randomised Trial ◽  
Neuromuscular Monitoring ◽  
Double Blind ◽  
Duration Of Action ◽  
Prospective Randomised Trial ◽  
Clinical Comparison ◽  
Intraoperative Hypotension ◽  
Significant Difference

In a double blind, prospective, randomised trial in 30 women undergoing laparoscopy, atracurium and vecuronium were compared in equipotent (2 X ED95) doses. In the atracurium group, first twitch depression was significantly greater at one minute, and degree of fade significantly greater at one and two minutes, but thereafter neuromuscular monitoring showed no significant difference between the groups. Clinically there was no significant difference between the drugs. Mild intraoperative hypotension was equally common in both groups as was sinus bradycardia. Reversal and recovery were comparable in the two groups. Neostigmine was required in all patients and in three (one atracurium, two vecuronium) a second dose was administered on clinical grounds. Antagonism of the neuromuscular block is required with surgery of this duration despite the intermediate duration of action of the relaxant drugs.

scholarly journals Percutaneous laser disc decompression versus conventional microdiscectomy for patients with sciatica: Two-year results of a randomised controlled trial

2017 ◽  
Vol 23 (3) ◽  
pp. 313-324 ◽  
Author(s):  
Patrick A Brouwer ◽  
Ronald Brand ◽  
M Elske van den Akker-van Marle ◽  
Wilco CH Jacobs ◽  
Barry Schenk ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Disc Herniation ◽  
Randomised Trial ◽  
Prospective Trial ◽  
Leg Pain ◽  
Conventional Surgery ◽  
Laser Disc ◽  
Operation Rate ◽  
Significant Difference

Background Percutaneous laser disc decompression is a minimally invasive treatment, for lumbar disc herniation and might serve as an alternative to surgical management of sciatica. In a randomised trial with two-year follow-up we assessed the clinical effectiveness of percutaneous laser disc decompression compared to conventional surgery. Materials and methods This multicentre randomised prospective trial with a non-inferiority design, was carried out according to an intent-to-treat protocol with full institutional review board approval. One hundred and fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were randomly allocated to percutaneous laser disc decompression ( n = 55) or conventional surgery ( n = 57). The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analogue scores for back and leg pain and the patient's report of perceived recovery. Results The primary outcome measures showed no significant difference or clinically relevant difference between the two groups at two-year follow-up. The re-operation rate was 21% in the surgery group, which is relatively high, and with an even higher 52% in the percutaneous laser disc decompression group. Conclusion At two-year follow-up, a strategy of percutaneous laser disc decompression, followed by surgery if needed, resulted in non-inferior outcomes compared to a strategy of microdiscectomy. Although the rate of reoperation in the percutaneous laser disc decompression group was higher than expected, surgery could be avoided in 48% of those patients that were originally candidates for surgery. Percutaneous laser disc decompression, as a non-surgical method, could have a place in the treatment arsenal of sciatica caused by contained herniated discs.

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