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Cardiovascular and Interventional... Sep 2021This systematic review was conducted to determine factors that are associated with the degree of hypertrophy of the future liver remnant following portal vein...
This systematic review was conducted to determine factors that are associated with the degree of hypertrophy of the future liver remnant following portal vein embolization. An extensive search on September 15, 2020, and subsequent literature screening resulted in the inclusion of forty-eight articles with 3368 patients in qualitative analysis, of which 18 studies were included in quantitative synthesis. Meta-analyses based on a limited number of studies showed an increase in hypertrophy response when additional embolization of segment 4 was performed (pooled difference of medians = - 3.47, 95% CI - 5.51 to - 1.43) and the use of N-butyl cyanoacrylate for portal vein embolization induced more hypertrophy than polyvinyl alcohol (pooled standardized mean difference (SMD) = 0.60, 95% CI 0.30 to 0.91). There was no indication of a difference in degree of hypertrophy between patients who received neo-adjuvant chemotherapy and those who did not receive pre-procedural systemic therapy(pooled SMD = - 0.37, 95% CI - 1.35 to 0.61), or between male and female patients (pooled SMD = 0.19, 95% CI - 0.12 to 0.50).The study was registered in the International Prospective Register of Systematic Reviews on April 28, 2020 (CRD42020175708).
Topics: Embolization, Therapeutic; Hepatectomy; Humans; Hypertrophy; Liver; Liver Neoplasms; Portal Vein; Retrospective Studies
PubMed: 34142192
DOI: 10.1007/s00270-021-02877-3 -
Journal of Vascular Surgery Sep 2021The long-term success of endovascular aneurysm repair (EVAR) is limited by complications, most importantly endoleaks. In case of (persistent) type I endoleak (T1EL),...
OBJECTIVE
The long-term success of endovascular aneurysm repair (EVAR) is limited by complications, most importantly endoleaks. In case of (persistent) type I endoleak (T1EL), secondary intervention is indicated to prevent secondary aneurysm rupture. Different treatment options are suggested for T1ELs, such as endo anchors, (fenestrated) cuffs, embolization, or open conversion. Currently, the treatment of T1EL with liquid embolic agents is available; however, results are not yet addressed. This review presents the safety and efficacy of embolization with liquid embolic agents for treatment of T1ELs after EVAR.
METHODS
A systematic literature search was performed for all studies reporting the use of liquid embolic agents as monotherapy for treatment of T1ELs after EVAR. Patient numbers, technical success (successful delivery of liquid embolics in the T1EL) and clinical success (absence of aneurysm related death, endoleak recurrence or additional interventions during follow-up) were examined.
RESULTS
Of 1604 articles, 10 studies met the selection criteria, including 194 patients treated with liquid embolics; 73.2% of the patients were male with a median age of 71 years. The overall technical success was 97.9%. Clinical success was 87.6%. Because the median follow-up was only 13.0 months (range, 1-89 months), data on long-term success are almost absent. Four cases (2.1%) of secondary aneurysm rupture after embolization owing to endoleak recurrence were reported. All ruptures occurred in aneurysms exceeding initial treatment diameter of 70 mm.
CONCLUSIONS
Initial technical success after liquid embolization for T1EL is high, although long-term clinical success rates are lacking. Within this review, the risk of secondary rupture is comparable with untreated T1EL at 2% with a median follow-up of 13 months, regardless of the initial success of embolization. In general, no decrease in secondary aneurysm rupture after embolization of T1EL after EVAR is demonstrated, although the results of late embolization are debated.
Topics: Aged; Aged, 80 and over; Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis Implantation; Dimethyl Sulfoxide; Embolization, Therapeutic; Enbucrilate; Endoleak; Endovascular Procedures; Female; Humans; Male; Polyvinyls; Risk Assessment; Risk Factors; Thrombin; Time Factors; Treatment Outcome
PubMed: 33940072
DOI: 10.1016/j.jvs.2021.03.061 -
Obstetrical & Gynecological Survey Apr 2021Postpartum hemorrhage (PPH) is an emergent obstetric complication and the leading cause of maternal mortality. Pelvic arterial embolization (PAE) is an effective... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Postpartum hemorrhage (PPH) is an emergent obstetric complication and the leading cause of maternal mortality. Pelvic arterial embolization (PAE) is an effective treatment for intractable PPH. However, a unique protocol has not been accepted in obstetrical practice.
OBJECTIVE
To evaluate its efficiency, safety, complications, and outcomes, we conducted a systematic review and meta-analysis of PAE for PPH in the literature.
EVIDENCE ACQUISITION
The Medline, the database of abstract of reviews, the index to allied health literature, and the Chinese database Sino-Med were searched on March 31, 2020, for studies on PAE for PPH. The data for PAE indication, agents, arteries, success rate, complications, and outcomes were extracted and syncretized for meta-analysis.
RESULTS
From 1075 identified articles, 113 abstracts or full articles were retrieved and 43 studies were finally identified as meeting the including criteria. The results demonstrated that the indications for PAE were as follows: uterine atony, placental abnormality, delivery tract injury, disseminated intravascular coagulation, arteriovenous malformation, and vaginal hematoma. The embolization agents mostly in order were gelatin sponge particles, polyvinyl alcohol particles, Gelfoam, -butyl cyanoacrylate, microcoil, and glue; for arteries, they were mostly uterine artery and internal iliac artery. The clinical success rate was 90.5%, whereas the technical success rate was 99.3%. The most common complications of PAE were postembolization syndrome and menstrual abnormality.
CONCLUSIONS AND RELEVANCE
The emergent PAE is a safe and effective method with high success rate in life-threatening PPH management. Gelatin sponge granules measuring 500 to 1000 μm in diameter have safe results. Pelvic arterial embolization may affect the recovery of menses and increase PPH in the subsequent pregnancy, but there was no noted correlation with fetal growth restriction.
Topics: Adult; Embolization, Therapeutic; Female; Humans; Iliac Artery; Pelvis; Postpartum Hemorrhage; Pregnancy; Treatment Outcome; Uterine Artery
PubMed: 33908615
DOI: 10.1097/OGX.0000000000000887 -
Value in Health : the Journal of the... Apr 2021Gastrointestinal (GI) bleeding is a common medical emergency associated with significant mortality. Transcatheter arterial embolization first was introduced by Rosch... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Gastrointestinal (GI) bleeding is a common medical emergency associated with significant mortality. Transcatheter arterial embolization first was introduced by Rosch et al as an alternative to surgery for upper GI bleeding. The clinical success in patients with GI bleeding treated with transcatheter arterial embolization previously has been reported. However, there are no cost-effectiveness analyses reported to date. Here we report cost-effectiveness analysis of N-butyl 2-cyanoacrylate glue (NBCA) and ethylene-vinyl alcohol copolymer (Onyx) versus coil (gold standard) for treatment of GI bleeding from a healthcare payer perspective.
METHODS
Fixed-effects modeling with a generalized linear mixed method was used in NBCA and coil intervention arms to determine the pooled probabilities of clinical success and mortality with complications with their confidence intervals, while the Clopper-Pearson model was used for Onyx to determine the same parameters. Models were provided by the "Meta-Analysis with R" software package. A decision tree was built for cost-effectiveness analysis, and Microsoft Excel was used for probabilistic sensitivity analysis. The cost-effective option was determined based on the incremental cost-effectiveness ratio and scatter plots of incremental cost versus incremental quality-adjusted life-years.
RESULTS
Comparing scatter plots and incremental cost-effectiveness ratio results, -$1024 and -$1349 per quality-adjusted life-year for Onyx and N-butyl 2-cyanoacrylate glue, respectively, Onyx was the least expensive and most effective intervention.
CONCLUSION
Onyx was the dominant strategy regardless of threshold values. Our analyses provide a framework for researchers to predict the target clinical effectiveness for early-stage TAE interventions and guide resource allocation decisions.
Topics: Arteries; Catheterization; Cost-Benefit Analysis; Decision Trees; Embolization, Therapeutic; Enbucrilate; Gastrointestinal Hemorrhage; Humans; Monte Carlo Method; Polyvinyls
PubMed: 33840425
DOI: 10.1016/j.jval.2020.10.027 -
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... Nov 2020Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an...
BACKGROUND
Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an ageing population. Women experience a variety of troublesome symptoms as a consequence of prolapse, including a feeling of 'something coming down' into the vagina, pain, urinary symptoms, bowel symptoms and sexual difficulties. Treatment for prolapse includes surgery, pelvic floor muscle training (PFMT) and vaginal pessaries. Vaginal pessaries are passive mechanical devices designed to support the vagina and hold the prolapsed organs back in the anatomically correct position. The most commonly used pessaries are made from polyvinyl-chloride, polythene, silicone or latex. Pessaries are frequently used by clinicians with high numbers of clinicians offering a pessary as first-line treatment for prolapse. This is an update of a Cochrane Review first published in 2003 and last published in 2013.
OBJECTIVES
To assess the effects of pessaries (mechanical devices) for managing pelvic organ prolapse in women; and summarise the principal findings of relevant economic evaluations of this intervention.
SEARCH METHODS
We searched the Cochrane Incontinence Specialised Register which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 January 2020). We searched the reference lists of relevant articles and contacted the authors of included studies.
SELECTION CRITERIA
We included randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in at least one arm of the study.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed abstracts, extracted data, assessed risk of bias and carried out GRADE assessments with arbitration from a third review author if necessary.
MAIN RESULTS
We included four studies involving a total of 478 women with various stages of prolapse, all of which took place in high-income countries. In one trial, only six of the 113 recruited women consented to random assignment to an intervention and no data are available for those six women. We could not perform any meta-analysis because each of the trials addressed a different comparison. None of the trials reported data about perceived resolution of prolapse symptoms or about psychological outcome measures. All studies reported data about perceived improvement of prolapse symptoms. Generally, the trials were at high risk of performance bias, due to lack of blinding, and low risk of selection bias. We downgraded the certainty of evidence for imprecision resulting from the low numbers of women participating in the trials. Pessary versus no treatment: at 12 months' follow-up, we are uncertain about the effect of pessaries compared with no treatment on perceived improvement of prolapse symptoms (mean difference (MD) in questionnaire scores -0.03, 95% confidence interval (CI) -0.61 to 0.55; 27 women; 1 study; very low-certainty evidence), and cure or improvement of sexual problems (MD -0.29, 95% CI -1.67 to 1.09; 27 women; 1 study; very low-certainty evidence). In this comparison we did not find any evidence relating to prolapse-specific quality of life or to the number of women experiencing adverse events (abnormal vaginal bleeding or de novo voiding difficulty). Pessary versus pelvic floor muscle training (PFMT): at 12 months' follow-up, we are uncertain if there is a difference between pessaries and PFMT in terms of women's perceived improvement in prolapse symptoms (MD -9.60, 95% CI -22.53 to 3.33; 137 women; low-certainty evidence), prolapse-specific quality of life (MD -3.30, 95% CI -8.70 to 15.30; 1 study; 116 women; low-certainty evidence), or cure or improvement of sexual problems (MD -2.30, 95% -5.20 to 0.60; 1 study; 48 women; low-certainty evidence). Pessaries may result in a large increase in risk of adverse events compared with PFMT (RR 75.25, 95% CI 4.70 to 1205.45; 1 study; 97 women; low-certainty evidence). Adverse events included increased vaginal discharge, and/or increased urinary incontinence and/or erosion or irritation of the vaginal walls. Pessary plus PFMT versus PFMT alone: at 12 months' follow-up, pessary plus PFMT probably leads to more women perceiving improvement in their prolapse symptoms compared with PFMT alone (RR 2.15, 95% CI 1.58 to 2.94; 1 study; 260 women; moderate-certainty evidence). At 12 months' follow-up, pessary plus PFMT probably improves women's prolapse-specific quality of life compared with PFMT alone (median (interquartile range (IQR)) POPIQ score: pessary plus PFMT 0.3 (0 to 22.2); 132 women; PFMT only 8.9 (0 to 64.9); 128 women; P = 0.02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding compared with PFMT alone (RR 2.18, 95% CI 0.69 to 6.91; 1 study; 260 women; low-certainty evidence). The evidence is uncertain if pessary plus PFMT has any effect on the risk of de novo voiding difficulty compared with PFMT alone (RR 1.32, 95% CI 0.54 to 3.19; 1 study; 189 women; low-certainty evidence).
AUTHORS' CONCLUSIONS
We are uncertain if pessaries improve pelvic organ prolapse symptoms for women compared with no treatment or PFMT but pessaries in addition to PFMT probably improve women's pelvic organ prolapse symptoms and prolapse-specific quality of life. However, there may be an increased risk of adverse events with pessaries compared to PFMT. Future trials should recruit adequate numbers of women and measure clinically important outcomes such as prolapse specific quality of life and resolution of prolapse symptoms. The review found two relevant economic evaluations. Of these, one assessed the cost-effectiveness of pessary treatment, expectant management and surgical procedures, and the other compared pessary treatment to PFMT.
Topics: Bias; Female; Humans; Muscle Strength; Pelvic Floor; Pelvic Organ Prolapse; Pessaries; Randomized Controlled Trials as Topic; Rectal Prolapse; Urethral Diseases; Urinary Bladder Diseases; Uterine Prolapse
PubMed: 33207004
DOI: 10.1002/14651858.CD004010.pub4 -
The Cochrane Database of Systematic... Sep 2020Ophthalmia neonatorum is an infection of the eyes in newborns that can lead to blindness, particularly if the infection is caused by Neisseria gonorrhoeae. Antiseptic... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Ophthalmia neonatorum is an infection of the eyes in newborns that can lead to blindness, particularly if the infection is caused by Neisseria gonorrhoeae. Antiseptic or antibiotic medication is dispensed into the eyes of newborns, or dispensed systemically, soon after delivery to prevent neonatal conjunctivitis and potential vision impairment.
OBJECTIVES
1. To determine if any type of systemic or topical eye medication is better than placebo or no prophylaxis in preventing ophthalmia neonatorum. 2. To determine if any one systemic or topical eye medication is better than any other medication in preventing ophthalmia neonatorum.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, LILACS, and three trials registers, date of last search 4 October 2019. We also searched references of included studies and contacted pharmaceutical companies. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials of any topical, systemic, or combination medical interventions used to prevent ophthalmia neonatorum in newborns compared with placebo, no prophylaxis, or with each other.
DATA COLLECTION AND ANALYSIS
We used standard methods expected by Cochrane. Outcomes were: blindness or any adverse visual outcome at 12 months, conjunctivitis at 1 month (gonococcal (GC), chlamydial (CC), bacterial (BC), any aetiology (ACAE), or unknown aetiology (CUE)), and adverse effects. MAIN RESULTS: We included 30 trials with a total of 79,198 neonates. Eighteen studies were conducted in high-income settings (the USA, Europe, Israel, Canada), and 12 were conducted in low- and middle-income settings (Africa, Iran, China, Indonesia, Mexico). Fifteen of the 30 studies were quasi-randomised. We judged every study to be at high risk of bias in at least one domain. Ten studies included a comparison arm with no prophylaxis. There were 14 different prophylactic regimens and 12 different medications in the 30 included studies. Any prophylaxis compared to no prophylaxis Unless otherwise indicated, the following evidence comes from studies assessing one or more of the following interventions: tetracycline 1%, erythromycin 0.5%, povidone-iodine 2.5%, silver nitrate 1%. None of the studies reported data on the primary outcomes: blindness or any adverse visual outcome at any time point. There was only very low-certainty evidence on the risk of GC with prophylaxis (4/5340 newborns) compared to no prophylaxis (5/2889) at one month (risk ratio (RR) 0.79, 95% confidence interval (CI) 0.24 to 2.65, 3 studies). Low-certainty evidence suggested there may be little or no difference in effect on CC (RR 0.96, 95% CI 0.57 to 1.61, 4874 newborns, 2 studies) and BC (RR 0.84, 95% CI 0.37 to 1.93, 3685 newborns, 2 studies). Moderate-certainty evidence suggested a probable reduction in risk of ACAE at one month (RR 0.65, 95% 0.54 to 0.78, 9666 newborns, 8 studies assessing tetracycline 1%, erythromycin 0.5%, povidone-iodine 2.5%, silver nitrate 1%, colostrum, bacitracin-phenacaine ointment). There was only very low-certainty evidence on CUE (RR 1.75, 95% CI 0.37 to 8.28, 330 newborns, 1 study). Very low-certainty evidence on adverse effects suggested no increased nasolacrimal duct obstruction (RR 0.93, 95% CI 0.68 to 1.28, 404 newborns, 1 study of erythromycin 0.5% and silver nitrate 1%) and no increased keratitis (single study of 40 newborns assessing silver nitrate 1% with no events). Any prophylaxis compared to another prophylaxis Overall, evidence comparing different interventions did not suggest any consistently superior intervention. However, most of this evidence was of low-certainty and was extremely limited.
AUTHORS' CONCLUSIONS
There are no data on whether prophylaxis for ophthalmia neonatorum prevents serious outcomes such as blindness or any adverse visual outcome. Moderate-certainty evidence suggests that the use of prophylaxis may lead to a reduction in the incidence of ACAE in newborns but the evidence for effect on GC, CC or BC was less certain. Comparison of individual interventions did not suggest any consistently superior intervention, but data were limited. A trial comparing tetracycline, povidone-iodine (single administration), and chloramphenicol for GC and CC could potentially provide the community with an effective, universally applicable prophylaxis against ophthalmia neonatorum.
Topics: Anti-Infective Agents; Bias; Blindness; Erythromycin; Humans; Infant, Newborn; Ophthalmia Neonatorum; Povidone-Iodine; Randomized Controlled Trials as Topic; Silver Nitrate; Tetracycline; Trachoma; Vision Disorders
PubMed: 32959365
DOI: 10.1002/14651858.CD001862.pub4 -
Annals of Surgery Dec 2021There is uncertainty around preoperative skin antisepsis in clean surgery. Network meta-analysis provides more precise estimates than standard pairwise meta-analysis and... (Comparative Study)
Comparative Study Meta-Analysis
The Comparative Efficacy of Chlorhexidine Gluconate and Povidone-iodine Antiseptics for the Prevention of Infection in Clean Surgery: A Systematic Review and Network Meta-analysis.
OBJECTIVE
There is uncertainty around preoperative skin antisepsis in clean surgery. Network meta-analysis provides more precise estimates than standard pairwise meta-analysis and can rank interventions by efficacy, to better inform clinical decisions.
BACKGROUND
Infection is the most common and costly complication of surgery. The relative efficacy of CHG and PVI based skin antiseptics in clean surgery remains unclear.
METHODS
We searched for randomized or nonrandomized studies comparing the effect of different preparations of CHG and PVI on the dichotomous outcome of surgical site infection. We included studies of adults undergoing clean surgery. We excluded studies concerning indwelling vascular catheters, blood sampling, combination antiseptics or sequential applications of different antiseptics. We performed a network meta-analysis to estimate the relative efficacy of interventions using relative risks (RR).
RESULTS
We included 17 studies comparing 5 antiseptics in 14,593 individuals. The overall rate of surgical site infection was 3%. Alcoholic CHG 4%-5% was ranked as the most effective antiseptic as it halved the risk of surgical site infection when compared to aqueous PVI [RR 0.49 (95% confidence interval 0.24, 1.02)] and also to alcoholic PVI, although uncertainty was larger [RR 0.51 (95% confidence interval 0.21, 1.27)]. Adverse events related to antiseptic application were only observed with patients exposed to PVI.
CONCLUSIONS
Alcoholic formulations of 4%-5% CHG seem to be safe and twice as effective as PVI (alcoholic or aqueous solutions) in preventing infection after clean surgery in adults. Our findings concur with the literature on contaminated and clean-contaminated surgery, and endorse guidelines worldwide which advocate the use of alcoholic CHG for preoperative skin antisepsis.
REGISTRATION
PROSPERO ID CRD42018113001.
Topics: Adult; Anti-Infective Agents, Local; Chlorhexidine; Humans; Network Meta-Analysis; Povidone-Iodine; Preoperative Care; Surgical Wound Infection
PubMed: 32773627
DOI: 10.1097/SLA.0000000000004076 -
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 -
The Cochrane Database of Systematic... Jun 2020The risk of maternal mortality and morbidity is higher after caesarean section than for vaginal birth. With increasing rates of caesarean section, it is important to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The risk of maternal mortality and morbidity is higher after caesarean section than for vaginal birth. With increasing rates of caesarean section, it is important to minimise risks to the mother as much as possible. This review focused on different skin preparations to prevent infection. This is an update of a review last published in 2018.
OBJECTIVES
To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection.
SEARCH METHODS
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (9 July 2019), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised and quasi-randomised trials, evaluating any type of preoperative skin preparation (agents, methods or forms). We included studies presented only as abstracts, if there was enough information to assess risk of bias. Comparisons of interest in this review were between: different antiseptic agents (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different packages of skin preparation including a mix of agents and methods, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. We mainly focused on the comparison between different agents, with and without the use of drapes. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing.
DATA COLLECTION AND ANALYSIS
Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, extracted the data and checked data for accuracy. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included 13 individually-randomised controlled trials (RCTs), with a total of 6938 women who were undergoing caesarean section. Twelve trials (6916 women) contributed data to this review. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in India, Egypt, Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly at low risk of bias for most domains, although high risk of detection bias raised some specific concerns in a number of studies. Length of stay was only reported in one comparison. Antiseptic agents Parachlorometaxylenol with iodine versus iodine alone We are uncertain whether parachlorometaxylenol with iodine made any difference to the incidence of surgical site infection (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.04 to 2.99; 1 trial, 50 women), or endometritis (RR 0.88, 95% CI 0.56 to 1.38; 1 trial, 50 women) when compared with iodine alone, because the certainty of the evidence was very low. Adverse events (maternal or neonatal) were not reported. Chlorhexidine gluconate versus povidone iodine Moderate-certainty evidence suggested that chlorhexidine gluconate, when compared with povidone iodine, probably slightly reduces the incidence of surgical site infection (RR 0.72, 95% CI 0.58 to 0.91; 8 trials, 4323 women). This effect was still present in a sensitivity analysis after removing four trials at high risk of bias for outcome assessment (RR 0.87, 95% CI 0.62 to 1.23; 4 trials, 2037 women). Low-certainty evidence indicated that chlorhexidine gluconate, when compared with povidone iodine, may make little or no difference to the incidence of endometritis (RR 0.95, 95% CI 0.49 to 1.86; 3 trials, 2484 women). It is uncertain whether chlorhexidine gluconate reduces maternal skin irritation or allergic skin reaction (RR 0.64, 95% CI 0.28 to 1.46; 3 trials, 1926 women; very low certainty evidence). One small study (60 women) reported reduced bacterial growth at 18 hours after caesarean section for women who had chlorhexidine gluconate preparation compared with women who had povidone iodine preparation (RR 0.23, 95% CI 0.07 to 0.70). Methods Drape versus no drape This comparison investigated the use of drape versus no drape, following preparation of the skin with antiseptics. Low-certainty evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (RR 1.29, 95% confidence interval (CI) 0.97 to 1.71; 3 trials, 1373 women), and probably makes little or no difference to the length of stay in the hospital (mean difference (MD) 0.10 days, 95% CI -0.27 to 0.46; 1 trial, 603 women; moderate-certainty evidence). One trial compared an alcohol scrub and iodophor drape with a five-minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very-low certainty evidence). We were uncertain whether the combination of a one-minute alcohol scrub and a drape reduced the incidence of metritis when compared with a five-minute scrub, because the certainty of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The studies did not report on adverse events (maternal or neonatal).
AUTHORS' CONCLUSIONS
Moderate-certainty evidence suggests that preparing the skin with chlorhexidine gluconate before caesarean section is probably slightly more effective at reducing the incidence of surgical site infection in comparison to povidone iodine. For other outcomes examined there was insufficient evidence available from the included RCTs. Most of the evidence in this review was deemed to be very low or low certainty. This means that for most findings, our confidence in any evidence of an intervention effect is limited, and indicates the need for more high-quality research. Therefore, it is not yet clear what sort of skin preparation may be most effective for preventing postcaesarean surgical site infection, or for reducing other undesirable outcomes for mother and baby. Well-designed RCTs, with larger sample sizes are needed. High-priority questions include comparing types of antiseptic (especially iodine versus chlorhexidine), and application methods (scrubbing, swabbing, or draping). We found two studies that are ongoing; we will incorporate the results of these studies in future updates of this review.
Topics: Adult; Anti-Infective Agents, Local; Bandages; Cesarean Section; Chlorhexidine; Endometritis; Ethanol; Female; Humans; Iodine; Iodophors; Length of Stay; Povidone-Iodine; Pregnancy; Preoperative Care; Randomized Controlled Trials as Topic; Surgical Drapes; Surgical Wound Infection; Xylenes
PubMed: 32580252
DOI: 10.1002/14651858.CD007462.pub5