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The Cochrane Database of Systematic... Jul 2018Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on the postpartum woman's return to normal function and her ability to care for her baby. Despite the widespread use of prophylactic antibiotics, postoperative infectious morbidity still complicates cesarean deliveries. This is an update of a Cochrane review first published in 2010 and subsequently updated in 2012, and twice in 2014.
OBJECTIVES
To determine if cleansing the vagina with an antiseptic solution before a cesarean delivery decreases the risk of maternal infectious morbidities, including endometritis and wound complications. We also assessed the side effects of vaginal cleansing solutions to determine adverse events associated with the intervention.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (10 July 2017), and reference lists of retrieved studies.
SELECTION CRITERIA
We included randomized trials and one quasi-randomized trial assessing the impact of vaginal cleansing immediately before cesarean delivery with any type of antiseptic solution versus a placebo solution/standard of care on post-cesarean infectious morbidity. Cluster-randomized trials were eligible for inclusion but none were identified. We excluded trials that utilized vaginal preparation during labor or that did not use antibiotic surgical prophylaxis. We also excluded any trials using a cross-over design.
DATA COLLECTION AND ANALYSIS
At least three of the review authors independently assessed eligibility of the studies. Two review authors were assigned to extract study characteristics, quality assessments, and data from eligible studies.
MAIN RESULTS
We included 11 trials reporting results for 3403 women evaluating the effects of vaginal cleansing (eight using povidone-iodine, two chlorhexidine, one benzalkonium chloride) on post-cesarean infectious morbidity. Additionally, some trials used vaginal preparations using sponge sticks, douches, or soaked gauze wipes. The control groups were typically no vaginal preparation (eight trials) or the use of a saline vaginal preparation (three trials). The risk of bias in the studies reduced our confidence in the results for endometritis outcomes.Vaginal preparation with antiseptic solution immediately before cesarean delivery probably reduces the incidence of post-cesarean endometritis from 8.7% in control groups to 3.8% in vaginal cleansing groups (average risk ratio (RR) 0.36, 95% confidence interval (CI) 0.20 to 0.63, 10 trials, 3283 women, moderate quality of evidence). Subgroup analysis could not rule out larger reductions in endometritis with antiseptics in women who were in labor or in women whose membranes had ruptured when antiseptics were used. Risks of postoperative fever and postoperative wound infection may be slightly lowered by antiseptic preparation, but the confidence intervals around the effects for both outcomes are consistent with a large reduction in risk and no difference between groups (fever: RR 0.87 (0.72 to 1.05; wound infection: RR 0.74 (95% CI 0.49 to 1.11), both moderate-quality evidence). Two trials reported a lower risk of a composite outcome of wound complication or endometritis in women receiving preoperative vaginal preparation (RR 0.46, 95% CI 0.26 to 0.82, two trials, 499 women, moderate-quality evidence). No adverse effects were reported with either the povidone-iodine or chlorhexidine vaginal cleansing.
AUTHORS' CONCLUSIONS
Vaginal preparation with povidone-iodine or chlorhexidine solution compared to saline or not cleansing immediately before cesarean delivery probably reduces the risk of post-cesarean endometritis. Subgroup analysis could not rule out larger reductions in endometritis with antiseptics in women who were in labor or in women whose membranes had ruptured when antiseptics were used.The quality of the evidence using GRADE was moderate for all reported outcomes. We downgraded the outcome of post-cesarean endometritis and composite of wound complications or endometritis for risk of bias and postoperative fever and postoperative wound infections for wide CIs.As a simple, generally inexpensive intervention, providers may consider implementing preoperative vaginal cleansing with povidone-iodine or chlorhexidine before performing cesarean deliveries.
Topics: Administration, Intravaginal; Anti-Infective Agents, Local; Benzalkonium Compounds; Cesarean Section; Chlorhexidine; Disinfection; Endometritis; Female; Fever; Humans; Povidone-Iodine; Pregnancy; Preoperative Care; Randomized Controlled Trials as Topic; Surgical Wound Infection; Vagina
PubMed: 30016540
DOI: 10.1002/14651858.CD007892.pub6 -
American Journal of Ophthalmology Aug 2022To summarize key findings from a Cochrane systematic review of the effectiveness and safety of topical pharmacologic interventions compared with active control or... (Review)
Review
PURPOSE
To summarize key findings from a Cochrane systematic review of the effectiveness and safety of topical pharmacologic interventions compared with active control or placebo for epidemic keratoconjunctivitis (EKC).
DESIGN
Systematic review.
METHODS
We included randomized controlled trials that compared antiseptic agents, virustatic agents, or immune-modulating topical therapies with placebo or an active control. We adhered to Cochrane methods for trial selection, data extraction, risk of bias evaluation, and data synthesis.
RESULTS
Ten randomized controlled trials with 892 participants with acute or chronic EKC were included. Eight trials compared interventions with artificial tears or saline (n = 4) or with steroids (n = 4); two 3-arm trials contributed data to both comparisons. Estimates suggested that compared with tears, after povidone-iodine (PVP-I) alone (2 studies, 409 participants) more participants with acute EKC had resolution of symptoms (risk ratio [RR] 1.15 [95% confidence interval {CI} 1.07-1.24]) and signs (RR 3.19 [95% CI 2.29-4.45]) within 10 days. In 2 trials comparing treatments with steroid alone or steroid with levofloxacin, fewer eyes treated with PVP-I or polyvinyl alcohol iodine (PVA-I) plus steroid developed subepithelial infiltrates within 21 days (RR 0.08 [95% CI 0.01-0.55]; 69 eyes). No treatment was shown to improve resolution of infiltrates.
CONCLUSIONS
Low- to very low-level certainty of evidence suggested that PVP-I or PVA-I with steroid may confer some benefit in acute EKC, but imprecision from small sample sizes, the potential risk of bias from inadequate reporting or trial design, and variability in participant selection, outcome measurement, and reporting limit the amount and quality of evidence.
Topics: Anti-Infective Agents, Local; Humans; Keratoconjunctivitis; Lubricant Eye Drops; Povidone-Iodine
PubMed: 35331686
DOI: 10.1016/j.ajo.2022.03.018 -
Ultrasound in Medicine & Biology Sep 2020Ischemic stroke is a leading cause of death and disability worldwide, so adequate prevention strategies are crucial. However, current stroke risk stratification is based...
Ischemic stroke is a leading cause of death and disability worldwide, so adequate prevention strategies are crucial. However, current stroke risk stratification is based on epidemiologic studies and is still suboptimal for individual patients. The aim of this systematic review was to provide a literature overview on the feasibility and diagnostic value of vascular shear wave elastography (SWE) using ultrasound (US) in (mimicked) human and non-human arteries affected by different stages of atherosclerotic diseases or diseases related to atherosclerosis. An online search was conducted on Pubmed, Embase, Web of Science and IEEE databases to identify studies using US SWE for the assessment of vascular elasticity. A quality assessment was performed using Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) checklist, and relevant data were extracted. A total of 19 studies were included: 10 with human patients and 9 with non-human subjects (i.e., [excised] animal arteries and polyvinyl alcohol phantoms). All studies revealed the feasibility of using US SWE to assess individually stiffness of the arterial wall and plaques. Quantitative elasticity values were highly variable between studies. However, within studies, SWE could detect statistically significant elasticity differences in patient/subject characteristics and could distinguish different plaque types with good reproducibility. US SWE, with its unique ability to assess the elasticity of the vessel wall and plaque throughout the cardiac cycle, might be a good candidate to improve stroke risk stratification. However, more clinical studies have to be performed to assess this technique's exact clinical value.
Topics: Atherosclerosis; Elasticity Imaging Techniques; Humans; Plaque, Atherosclerotic
PubMed: 32620385
DOI: 10.1016/j.ultrasmedbio.2020.05.013 -
International Journal of Environmental... Mar 2022The use of pre-procedural rinses has been investigated to reduce the number of viral particles and bacteria in aerosols, potentially decreasing the risk of... (Review)
Review
The use of pre-procedural rinses has been investigated to reduce the number of viral particles and bacteria in aerosols, potentially decreasing the risk of cross-infection from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during medical and dental procedures. This review aims to confirm whether there is evidence in the literature describing a reduction in salivary load of SARS-CoV-2 when povidone-iodine (PVP-I) is used as a pre-intervention mouthwash. An search of the MEDLINE, Embase, SCOPUS, and the Cochrane library databases was conducted. The criteria used followed the PRISMA Statement guidelines. Randomized controlled trials investigating the reduction of salivary load of SARS-CoV-2 using PVP-I were included. Ultimately, four articles were included that met the established criteria. According to the current evidence, PVP-I is effective against SARS-CoV-2 in saliva and could be implemented as a rinse before interventions to decrease the risk of cross-infection in healthcare settings.
Topics: COVID-19; Humans; Mouthwashes; Povidone-Iodine; Randomized Controlled Trials as Topic; SARS-CoV-2; Viral Load
PubMed: 35270569
DOI: 10.3390/ijerph19052877 -
The Cochrane Database of Systematic... Jan 2019Many smokers give up smoking on their own, but materials that provide a structured programme for smokers to follow may increase the number who quit successfully. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Many smokers give up smoking on their own, but materials that provide a structured programme for smokers to follow may increase the number who quit successfully.
OBJECTIVES
The aims of this review were to determine the effectiveness of different forms of print-based self-help materials that provide a structured programme for smokers to follow, compared with no treatment and with other minimal contact strategies, and to determine the comparative effectiveness of different components and characteristics of print-based self-help, such as computer-generated feedback, additional materials, tailoring of materials to individuals, and targeting of materials at specific groups.
SEARCH METHODS
We searched the Cochrane Tobacco Addiction Group Trials Register, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP). The date of the most recent search was March 2018.
SELECTION CRITERIA
We included randomised trials of smoking cessation with follow-up of at least six months, where at least one arm tested print-based materials providing self-help compared with minimal print-based self-help (such as a short leaflet) or a lower-intensity control. We defined 'self-help' as structured programming for smokers trying to quit without intensive contact with a therapist.
DATA COLLECTION AND ANALYSIS
We extracted data in accordance with standard methodological procedures set out by Cochrane. The main outcome measure was abstinence from smoking after at least six months' follow-up in people smoking at baseline. We used the most rigorous definition of abstinence in each study and biochemically validated rates when available. Where appropriate, we performed meta-analysis using a random-effects model.
MAIN RESULTS
We identified 75 studies that met our inclusion criteria. Many study reports did not include sufficient detail to allow judgement of risk of bias for some domains. We judged 30 studies (40%) to be at high risk of bias for one or more domains.Thirty-five studies evaluated the effects of standard, non-tailored self-help materials. Eleven studies compared self-help materials alone with no intervention and found a small effect in favour of the intervention (n = 13,241; risk ratio (RR) 1.19, 95% confidence interval (CI) 1.03 to 1.37; I² = 0%). We judged the evidence to be of moderate certainty in accordance with GRADE, downgraded for indirect relevance to populations in low- and middle-income countries because evidence for this comparison came from studies conducted solely in high-income countries and there is reason to believe the intervention might work differently in low- and middle-income countries. This analysis excluded two studies by the same author team with strongly positive outcomes that were clear outliers and introduced significant heterogeneity. Six further studies of structured self-help compared with brief leaflets did not show evidence of an effect of self-help materials on smoking cessation (n = 7023; RR 0.87, 95% CI 0.71 to 1.07; I² = 21%). We found evidence of benefit from standard self-help materials when there was brief contact that did not include smoking cessation advice (4 studies; n = 2822; RR 1.39, 95% CI 1.03 to 1.88; I² = 0%), but not when self-help was provided as an adjunct to face-to-face smoking cessation advice for all participants (11 studies; n = 5365; RR 0.99, 95% CI 0.76 to 1.28; I² = 32%).Thirty-two studies tested materials tailored for the characteristics of individual smokers, with controls receiving no materials, or stage-matched or non-tailored materials. Most of these studies used more than one mailing. Pooling studies that compared tailored self-help with no self-help, either on its own or compared with advice, or as an adjunct to advice, showed a benefit of providing tailored self-help interventions (12 studies; n = 19,190; RR 1.34, 95% CI 1.20 to 1.49; I² = 0%) with little evidence of difference between subgroups (10 studies compared tailored with no materials, n = 14,359; RR 1.34, 95% CI 1.19 to 1.51; I² = 0%; two studies compared tailored materials with brief advice, n = 2992; RR 1.13, 95% CI 0.86 to 1.49; I² = 0%; and two studies evaluated tailored materials as an adjunct to brief advice, n = 1839; RR 1.72, 95% CI 1.17 to 2.53; I² = 10%). When studies compared tailored self-help with non-tailored self-help, results favoured tailored interventions when the tailored interventions involved more mailings than the non-tailored interventions (9 studies; n = 14,166; RR 1.42, 95% CI 1.20 to 1.68; I² = 0%), but not when the two conditions were contact-matched (10 studies; n = 11,024; RR 1.07, 95% CI 0.89 to 1.30; I² = 50%). We judged the evidence to be of moderate certainty in accordance with GRADE, downgraded for risk of bias.Five studies evaluated self-help materials as an adjunct to nicotine replacement therapy; pooling three of these provided no evidence of additional benefit (n = 1769; RR 1.05, 95% CI 0.86 to 1.30; I² = 0%). Four studies evaluating additional written materials favoured the intervention, but the lower confidence interval crossed the line of no effect (RR 1.20, 95% CI 0.91 to 1.58; I² = 73%). A small number of other studies did not detect benefit from using targeted materials, or find differences between different self-help programmes.
AUTHORS' CONCLUSIONS
Moderate-certainty evidence shows that when no other support is available, written self-help materials help more people to stop smoking than no intervention. When people receive advice from a health professional or are using nicotine replacement therapy, there is no evidence that self-help materials add to their effect. However, small benefits cannot be excluded. Moderate-certainty evidence shows that self-help materials that use data from participants to tailor the nature of the advice or support given are more effective than no intervention. However, when tailored self-help materials, which typically involve repeated assessment and mailing, were compared with untailored materials delivered similarly, there was no evidence of benefit.Available evidence tested self-help interventions in high-income countries, where more intensive support is often available. Further research is needed to investigate effects of these interventions in low- and middle-income countries, where more intensive support may not be available.
Topics: Behavior Therapy; Chewing Gum; Humans; Nicotine; Pamphlets; Patient Education as Topic; Polymethacrylic Acids; Polyvinyls; Randomized Controlled Trials as Topic; Self Care; Smoking Cessation; Smoking Prevention; Temperance; Tobacco Use Cessation Devices
PubMed: 30623970
DOI: 10.1002/14651858.CD001118.pub4 -
Medicine Mar 2021The aim of this meta-analysis with trial sequential analysis (TSA) was to evaluate the effect of a polyurethane (PU) tracheal tube cuff on the prevention of... (Meta-Analysis)
Meta-Analysis
Comparison of polyurethane tracheal tube cuffs and conventional polyvinyl chloride tube cuff for prevention of ventilator-associated pneumonia: A systematic review with meta-analysis.
BACKGROUND
The aim of this meta-analysis with trial sequential analysis (TSA) was to evaluate the effect of a polyurethane (PU) tracheal tube cuff on the prevention of ventilator-associated pneumonia (VAP).
METHODS
We performed a systematic search using the MEDLINE database through PubMed, Cochrane Central Register of Controlled Trial, SCOPUS, and Web of Science.Randomized controlled trials comparing the incidence of VAP and clinically relevant outcomes between PU cuff tubes and polyvinyl chloride (PVC) cuff tubes in adult patients. Two authors independently extracted study details, patient characteristics, and clinical outcomes such as incidence of VAP, bacterial colonization of tracheal aspirate, duration of mechanical ventilation, ICU stay, and ICU mortality.
RESULTS
From 309 studies identified as potentially eligible, six studies with 1226 patients were included in this meta-analysis. All studies compared the incidence of VAP between PU cuffs and PVC cuffs. Use of a PU cuff was not associated with a reduction in VAP incidence (RR = 0.68; 95% CI, 0.45-1.03) with significant statistical heterogeneity (I2 = 65%). The quality of evidence was "very low." According to the TSA, the actual sample size was only 15.8% of the target sample size, and the cumulative Z score did not cross the trial sequential monitoring boundary for benefit. No positive impact was reported for the other relevant outcomes for PU cuffs.
CONCLUSIONS
The use of a PU cuff for mechanical ventilation did not prevent VAP. Further trials with a low risk of bias need to be performed.
Topics: Equipment Design; Humans; Intensive Care Units; Intubation, Intratracheal; Pneumonia, Ventilator-Associated; Polyurethanes; Polyvinyl Chloride; Respiration, Artificial
PubMed: 33655952
DOI: 10.1097/MD.0000000000024906 -
The Cochrane Database of Systematic... Apr 2015Surgical site infection rates in the month following clean surgery vary from 0.6% (knee prosthesis) to 5% (limb amputation). Due to the large number of clean surgical... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Surgical site infection rates in the month following clean surgery vary from 0.6% (knee prosthesis) to 5% (limb amputation). Due to the large number of clean surgical procedures conducted annually the costs of these surgical site infections (SSIs) can be considerable in financial and social terms. Preoperative skin antisepsis using antiseptics is performed to reduce the risk of SSIs by removing soil and transient organisms from the skin where a surgical incision will be made. Antiseptics are thought to be toxic to bacteria and therefore aid their mechanical removal. The effectiveness of preoperative skin preparation is thought to be dependent on both the antiseptic used and the method of application, however, it is unclear whether preoperative skin antisepsis actually reduces postoperative wound infection, and, if so, which antiseptic is most effective.
OBJECTIVES
To determine whether preoperative skin antisepsis immediately prior to surgical incision for clean surgery prevents SSI and to determine the comparative effectiveness of alternative antiseptics.
SEARCH METHODS
For this third update we searched just the Cochrane Wounds Group Specialised Register (searched 27 January 2015); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 12).
SELECTION CRITERIA
Randomised controlled trials evaluating the use of preoperative skin antiseptics applied immediately prior to incision in clean surgery. There was no restriction on the inclusion of reports based on language of publication, date or publication status.
DATA COLLECTION AND ANALYSIS
Data extraction and assessment of risk of bias were undertaken independently by two review authors.
MAIN RESULTS
There were no new studies added to the review in the third updateThirteen studies were included in this review (2,623 participants). These evaluated several different types of skin antiseptics - leading to 11 different comparisons being made. Although the antiseptics evaluated differed between studies, all trials involved some form of iodine. Iodine in alcohol was compared to alcohol alone in one trial; one trial compared povidone iodine paint (solution type not reported) with soap and alcohol. Six studies compared different types of iodine-containing products with each other and five compared iodine-containing products with chlorhexidine-containing products.There was evidence from one study suggesting that preoperative skin preparation with 0.5% chlorhexidine in methylated spirits led to a reduced risk of SSI compared with an alcohol based povidone iodine solution: RR 0.47 (95% CI 0.27 to 0.82). However, it is important to note that the trial does not report important details regarding the interventions (such as the concentration of povidone iodine paint used) and trial conduct, such that risk of bias was unclear.There were no other statistically significant differences in SSI rates in the other comparisons of skin antisepsis. Overall the risk of bias in included studies was unclear.A mixed treatment comparison meta-analysis was conducted and this suggested that alcohol-containing products had the highest probability of being effective - however, again the quality of this evidence was low.
AUTHORS' CONCLUSIONS
A comprehensive review of current evidence found some evidence that preoperative skin preparation with 0.5% chlorhexidine in methylated spirits was associated with lower rates of SSIs following clean surgery than alcohol-based povidone iodine paint. However this single study was poorly reported. Practitioners may therefore elect to consider other characteristics such as costs and potential side effects when choosing between alternatives.The design of future trials should be driven by the questions of high priority to decision makers. It may be that investment in at least one large trial (in terms of participants) is warranted in order to add definitive and hopefully conclusive data to the current evidence base. Ideally any future trial would evaluate the iodine-containing and chlorhexidine-containing solutions relevant to current practice as well as the type of solution used (alcohol vs. aqueous).
Topics: Anti-Infective Agents, Local; Chlorhexidine; Ethanol; Humans; Iodine Compounds; Povidone-Iodine; Preoperative Care; Randomized Controlled Trials as Topic; Surgical Wound Infection
PubMed: 25897764
DOI: 10.1002/14651858.CD003949.pub4 -
Veterinary Surgery : VS Jul 2022To provide a systematic assessment of the efficacy of preoperative skin asepsis using chlorhexidine versus povidone-iodine based protocols for surgical site infection... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To provide a systematic assessment of the efficacy of preoperative skin asepsis using chlorhexidine versus povidone-iodine based protocols for surgical site infection (SSI) prevention in veterinary surgery.
STUDY DESIGN
Systematic meta-analytical review according to PRISMA-P guidelines.
SAMPLE POPULATION
Studies comparing preoperative skin asepsis protocols using chlorhexidine versus povidone-iodine in veterinary surgery identified by systematic search between 1990 and 2020.
METHODS
A search using MEDLINE/Pubmed, Web of Science and CAB Abstracts was performed, followed by secondary searches of Google Scholar, Proquest Dissertation and Theses, and relevant bibliographic articles. Primary and secondary outcome measures were the efficacy of skin asepsis protocols using chlorhexidine versus povidone-iodine on SSI incidence and skin bacterial colonization, respectively. A meta-analysis was performed with a random-effect model, with effect size calculated as risk ratio (RR) or mean standard deviation (MSD) with 95% CI. Statistical significance was set at P < .05.
RESULTS
Among 1067 publications that met the initial search criteria, 9 relevant studies were eligible for analysis. No difference in the incidence of postoperative SSI or skin bacterial colonization between preoperative asepsis protocols using chlorhexidine versus povidone-iodine was found. Insufficient information and detail were frequent among studies and precluded a clear assessment of bias.
CONCLUSION
This study showed that asepsis protocols using chlorhexidine were comparable to povidone-iodine in preventing postoperative SSI and reducing skin bacterial colonization.
CLINICAL SIGNIFICANCE
Given the limitations of the studies that were included in terms of both quality and quantity, more high-quality randomized controlled trials are needed to confirm these conclusions.
Topics: Animals; Anti-Infective Agents, Local; Asepsis; Chlorhexidine; Clinical Protocols; Ethanol; Meta-Analysis as Topic; Povidone-Iodine; Preoperative Care; Surgery, Veterinary; Surgical Wound Infection
PubMed: 35437786
DOI: 10.1111/vsu.13810 -
The Cochrane Database of Systematic... Mar 2016Central venous catheters (CVCs) provide secured venous access in neonates. Antimicrobial dressings applied over the CVC sites have been proposed to reduce... (Review)
Review
BACKGROUND
Central venous catheters (CVCs) provide secured venous access in neonates. Antimicrobial dressings applied over the CVC sites have been proposed to reduce catheter-related blood stream infection (CRBSI) by decreasing colonisation. However, there may be concerns on the local and systemic adverse effects of these dressings in neonates.
OBJECTIVES
We assessed the effectiveness and safety of antimicrobial (antiseptic or antibiotic) dressings in reducing CVC-related infections in newborn infants. Had there been relevant data, we would have evaluated the effects of antimicrobial dressings in different subgroups, including infants who received different types of CVCs, infants who required CVC for different durations, infants with CVCs with and without other antimicrobial modifications, and infants who received an antimicrobial dressing with and without a clearly defined co-intervention.
SEARCH METHODS
We used the standard search strategy of the Cochrane Neonatal Review Group (CNRG). We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2015, Issue 9), MEDLINE (PubMed), EMBASE (EBCHOST), CINAHL and references cited in our short-listed articles using keywords and MeSH headings, up to September 2015.
SELECTION CRITERIA
We included randomised controlled trials that compared an antimicrobial CVC dressing against no dressing or another dressing in newborn infants.
DATA COLLECTION AND ANALYSIS
We extracted data using the standard methods of the CNRG. Two review authors independently assessed the eligibility and risk of bias of the retrieved records. We expressed our results using risk difference (RD) and risk ratio (RR) with 95% confidence intervals (CIs).
MAIN RESULTS
Out of 173 articles screened, three studies were included. There were two comparisons: chlorhexidine dressing following alcohol cleansing versus polyurethane dressing following povidone-iodine cleansing (one study); and silver-alginate patch versus control (two studies). A total of 855 infants from level III neonatal intensive care units (NICUs) were evaluated, 705 of whom were from a single study. All studies were at high risk of bias for blinding of care personnel or unclear risk of bias for blinding of outcome assessors. There was moderate-quality evidence for all major outcomes.The single study comparing chlorhexidine dressing/alcohol cleansing against polyurethane dressing/povidone-iodine cleansing showed no significant difference in the risk of CRBSI (RR 1.18, 95% CI 0.53 to 2.65; RD 0.01, 95% CI -0.02 to 0.03; 655 infants, moderate-quality evidence) and sepsis without a source (RR 1.06, 95% CI 0.75 to 1.52; RD 0.01, 95% CI -0.04 to 0.06; 705 infants, moderate-quality evidence). There was a significant reduction in the risk of catheter colonisation favouring chlorhexidine dressing/alcohol cleansing group (RR 0.62, 95% CI 0.45 to 0.86; RD -0.09, 95% CI -0.15 to -0.03; number needed to treat for an additional beneficial outcome (NNTB) 11, 95% CI 7 to 33; 655 infants, moderate-quality evidence). However, infants in the chlorhexidine dressing/alcohol cleansing group were significantly more likely to develop contact dermatitis, with 19 infants in the chlorhexidine dressing/alcohol cleansing group having developed contact dermatitis compared to none in the polyurethane dressing/povidone-iodine cleansing group (RR 43.06, 95% CI 2.61 to 710.44; RD 0.06, 95% CI 0.03 to 0.08; number needed to treat for an additional harmful outcome (NNTH) 17, 95% CI 13 to 33; 705 infants, moderate-quality evidence). The roles of chlorhexidine dressing in the outcomes reported were unclear, as the two assigned groups received different co-interventions in the form of different skin cleansing agents prior to catheter insertion and during each dressing change.In the other comparison, silver-alginate patch versus control, the data for CRBSI were analysed separately in two subgroups as the two included studies reported the outcome using different denominators: one using infants and another using catheters. There were no significant differences between infants who received silver-alginate patch against infants who received standard line dressing in CRBSI, whether expressed as the number of infants (RR 0.50, 95% CI 0.14 to 1.78; RD -0.12, 95% CI -0.33 to 0.09; 1 study, 50 participants, moderate-quality evidence) or as the number of catheters (RR 0.72, 95% CI 0.27 to 1.89; RD -0.05, 95% CI -0.20 to 0.10; 1 study, 118 participants, moderate-quality evidence). There was also no significant difference between the two groups in mortality (RR 0.55, 95% CI 0.15 to 2.05; RD -0.04, 95% CI -0.13 to 0.05; two studies, 150 infants, I² = 0%, moderate-quality evidence). No adverse skin reaction was recorded in either group.
AUTHORS' CONCLUSIONS
Based on moderate-quality evidence, chlorhexidine dressing/alcohol skin cleansing reduced catheter colonisation, but made no significant difference in major outcomes like sepsis and CRBSI compared to polyurethane dressing/povidone-iodine cleansing. Chlorhexidine dressing/alcohol cleansing posed a substantial risk of contact dermatitis in preterm infants, although it was unclear whether this was contributed mainly by the dressing material or the cleansing agent. While silver-alginate patch appeared safe, evidence is still insufficient for a recommendation in practice. Future research that evaluates antimicrobial dressing should ensure blinding of caregivers and outcome assessors and ensure that all participants receive the same co-interventions, such as the skin cleansing agent. Major outcomes like sepsis, CRBSI and mortality should be assessed in infants of different gestation and birth weight.
Topics: Alginates; Anti-Bacterial Agents; Anti-Infective Agents; Bandages; Catheter-Related Infections; Catheterization, Central Venous; Central Venous Catheters; Chlorhexidine; Dermatitis, Contact; Ethanol; Glucuronic Acid; Hexuronic Acids; Humans; Infant, Newborn; Polyurethanes; Povidone-Iodine; Randomized Controlled Trials as Topic; Silver Compounds
PubMed: 27007217
DOI: 10.1002/14651858.CD011082.pub2 -
The Cochrane Database of Systematic... Jul 2019At the end of 2016, 145 countries reported to the World Health Organization (WHO) over 173,000 new cases of leprosy worldwide. In the past 20 years, over 16 million... (Review)
Review
BACKGROUND
At the end of 2016, 145 countries reported to the World Health Organization (WHO) over 173,000 new cases of leprosy worldwide. In the past 20 years, over 16 million people have been treated for leprosy globally. The condition's main complications are injuries and ulceration caused by sensory loss from nerve damage. In this review we explored interventions to prevent or treat secondary damage to the skin in people affected by leprosy (Hansen's disease). This is an update of a Cochrane Review published in 2008.
OBJECTIVES
To assess the effects of education, information, self-care programmes, dressings, skin care, footwear and other measures for preventing and healing secondary damage to the skin in persons affected by leprosy.
SEARCH METHODS
We updated our searches of the following databases up to July 2018: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, AMED, LILACS, and CINAHL. We also searched five trial registers, three grey literature databases, and the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).
SELECTION CRITERIA
RCTs or quasi-RCTs or randomised cross-over trials involving anyone with leprosy and potential damage to peripheral nerves who was treated with any intervention designed to prevent damage, heal existing ulcers, and prevent development of new ulcers. Eligible comparisons were usual care, no interventions, or other interventions (e.g. other types of dressings or footwear).
DATA COLLECTION AND ANALYSIS
We adhered to standard methodological procedures expected by Cochrane. Primary outcomes were prevention of ulcer(s), healing of existing ulcer(s) and adverse events. We used GRADE to assess the certainty of evidence for each outcome.
MAIN RESULTS
We included 14 trials (854 participants). Eleven studies reported on gender (men: 472, women: 157). Participant age varied from 18 to 74 years. Most participants had a single, mainly non-infected, wound on one foot, which had been there for less than a year. Only seven studies reported whole study duration (there was no follow-up post-treatment), which was on average six months (range: 1 to 12 months). The studies were conducted in Brazil, Ethiopia, Egypt, Indonesia, Mexico, South Korea, and India. Many 'Risk of bias' assessments were rated as unclear risk due to limited information. Six studies had high risk of bias in at least one domain, including selection and attrition bias.Thirteen studies evaluated different interventions for treating existing ulcers, one of them also evaluated prevention of new ulcers. One study aimed to prevent skin changes, such as cracking and fissures. Investigated interventions included: laser therapy, light-emitting diode (LED), zinc tape, intralesional pentoxifylline, pulsed magnetic fields, wax therapy, ketanserin, human amniotic membrane gel, phenytoin, plaster shoes, and footwear.We are uncertain about the following key results, as the certainty of evidence is very low. All time points were measured from baseline.Three studies compared zinc tape versus other interventions and reported results in favour of zinc tape. One study compared zinc tape versus magnesium sulphate: at one month the number of healed ulcers and reduction in mean ulcer area was higher with zinc tape (risk ratio (RR) 2.00, 95% confidence interval (CI) 0.43 to 9.21, and mean difference (MD) -14.30 mm², 95% CI -26.51 to -2.09, respectively, 28 participants). Another study compared zinc tape and povidone iodine and found that even though there was a greater reduction in ulcer area after six weeks of treatment with zinc tape, there was no clear difference due to the wide 95% CI (MD 128.00 mm², 95% CI -110.01 to 366.01; 38 participants). The third study (90 participants) compared adhesive zinc tape with gauze soaked in Eusol, and found the healing time for deep ulcers was less compared to zinc tape: 17 days (95% CI 12 to 20) versus 30 days (95% CI 21 to 63). Adverse events were only collected in the study comparing zinc tape with gauze soaked in Eusol: there were no signs of skin sensitisation in either group at two months.Two studies compared topical phenytoin versus saline dressing and reported results in favour of phenytoin. One study reported a greater mean percentage reduction of ulcer area after four weeks with phenytoin 2% (MD 39.30%, 95% CI 25.82 to 52.78; 23 participants), and the other study reported a greater mean percentage reduction of ulcer volume (16.60%) after four weeks with phenytoin (95% CI 8.46 to 24.74; 100 participants). No adverse events were observed with either treatment during the four-month treatment period (2 studies, 123 participants). Prevention of ulcers was not evaluated in these nor the zinc studies, as the interventions were not for preventative use.Two studies compared protective footwear (with or without self-care) with either 1) polyvinyl chloride (PVC) boots, or 2) pulsed magnetic fields plus self-care and protective footwear. In the study comparing canvas shoes versus PVC boots, none of the 72 participants with scars at the start of the study developed new ulcers over one-year follow-up. Healing of ulcers was assessed in 38 participants from this study, but we are unclear if there is a difference between groups. In the study comparing pulsed magnetic fields (in addition to self-care and protective footwear) to only self-care and footwear in 33 participants, we are uncertain if the mean volume of ulcers at four to five weeks' follow-up was different between groups; this study did not evaluate the prevention of ulcers. Information for adverse events was only reported in the study comparing canvas shoes with PVC boots; the authors stated that the PVC boots could become hot in strong sunlight and possibly burn the feet.
AUTHORS' CONCLUSIONS
Based on the available evidence, we could not draw firm conclusions about the effects of the included interventions. The main evidence limitations were high or unclear risk of bias, including selection, performance, detection, and attrition bias; imprecision due to few participants in the studies; and indirectness from poor outcome measurement and inapplicable interventions. Future research should clearly report important outcomes, such as adverse events, and assess widely available interventions, which should include treatments aimed at prevention. These trials should ensure allocation concealment, blinding, and an adequate sample size.
PubMed: 31425632
DOI: 10.1002/14651858.CD012235.pub2