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BMJ Clinical Evidence Apr 2011Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers in up to one third of people in hospitals or community care,... (Review)
Review
INTRODUCTION
Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers in up to one third of people in hospitals or community care, and one fifth of nursing home residents. Pressure ulcers are more likely in people with reduced mobility and poor skin condition, such as older people or those with vascular disease.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of preventive interventions in people at risk of developing pressure ulcers? What are the effects of treatments in people with pressure ulcers? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 64 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: air-filled vinyl boots, air-fluidised supports, alternating-pressure surfaces (including mattresses), alternative foam mattresses, constant low-pressure supports, debridement, electric profiling beds, electrotherapy, hydrocellular heel supports, low-air-loss beds (including hydrotherapy beds), low-level laser therapy, low-tech constant-low-pressure supports, medical sheepskin overlays, nutritional supplements, orthopaedic wool padding, pressure-relieving overlays on operating tables, pressure-relieving surfaces, repositioning (regular "turning"), seat cushions, standard beds, standard care, standard foam mattresses, standard tables, surgery, therapeutic ultrasound, topical lotions and dressings, topical negative pressure, and topical phenytoin.
Topics: Anticonvulsants; Bandages; Bedding and Linens; Beds; Debridement; Humans; Low-Level Light Therapy; Negative-Pressure Wound Therapy; Patient Positioning; Phenytoin; Pressure Ulcer; Standard of Care; Ultrasonic Therapy
PubMed: 21524319
DOI: No ID Found -
The Cochrane Database of Systematic... Feb 2018Newborn admission temperature is a strong predictor of outcomes across all gestations. Hypothermia immediately after birth remains a worldwide issue and, if prolonged,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Newborn admission temperature is a strong predictor of outcomes across all gestations. Hypothermia immediately after birth remains a worldwide issue and, if prolonged, is associated with harm. Keeping preterm infants warm is difficult even when recommended routine thermal care guidelines are followed in the delivery room.
OBJECTIVES
To assess the efficacy and safety of interventions designed for prevention of hypothermia in preterm and/or low birth weight infants applied within 10 minutes after birth in the delivery room, compared with routine thermal care or any other single/combination of intervention(s) also designed for prevention of hypothermia in preterm and/or low birth weight infants applied within 10 minutes after birth in the delivery room.
SEARCH METHODS
We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 5), MEDLINE via PubMed (1966 to 30 June 2016), Embase (1980 to 30 June 2016), and CINAHL (1982 to 30 June 2016). We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.
SELECTION CRITERIA
Trials using randomised or quasi-randomised allocations to test interventions designed to prevent hypothermia (apart from 'routine' thermal care) applied within 10 minutes after birth in the delivery room for infants at < 37 weeks' gestation and/or birth weight ≤ 2500 grams.
DATA COLLECTION AND ANALYSIS
We used Cochrane Neonatal methods when performing data collection and analysis.
MAIN RESULTS
Twenty-five studies across 15 comparison groups met the inclusion criteria, categorised as: barriers to heat loss (18 studies); external heat sources (three studies); and combinations of interventions (four studies).Barriers to heat loss Plastic wrap or bag versus routine carePlastic wraps improved core body temperature on admission to the neonatal intensive care unit (NICU) or up to two hours after birth (mean difference (MD) 0.58°C, 95% confidence interval (CI) 0.50 to 0.66; 13 studies; 1633 infants), and fewer infants had hypothermia on admission to the NICU or up to two hours after birth (typical risk ratio (RR) 0.67, 95% CI 0.62 to 0.72; typical risk reduction (RD) -0.25, 95% CI -0.29 to -0.20; number needed to treat for an additional beneficial outcome (NNTB) 4, 95% CI 4 to 5; 10 studies; 1417 infants). Risk of hyperthermia on admission to the NICU or up to two hours after birth was increased in infants in the wrapped group (typical RR 3.91, 95% CI 2.05 to 7.44; typical RD 0.04, 95% CI 0.02 to 0.06; number needed to treat for an additional harmful outcome (NNTH) 25, 95% CI 17 to 50; 12 studies; 1523 infants), but overall, fewer infants receiving plastic wrap were outside the normothermic range (typical RR 0.75, 95% CI 0.69 to 0.81; typical RD -0.20, 95% CI -0.26 to -0.15; NNTH 5, 95% CI 4 to 7; five studies; 1048 infants).Evidence was insufficient to suggest that plastic wraps or bags significantly reduce risk of death during hospital stay or other major morbidities, with the exception of reducing risk of pulmonary haemorrhage.Evidence of practices regarding permutations on this general approach is still emerging and has been based on the findings of only one or two small studies.External heat sourcesEvidence is emerging on the efficacy of external heat sources, including skin-to-skin care (SSC) versus routine care (one study; 31 infants) and thermal mattress versus routine care (two studies; 126 infants).SSC was shown to be effective in reducing risk of hypothermia when compared with conventional incubator care for infants with birth weight ≥ 1200 and ≤ 2199 grams (RR 0.09, 95% CI 0.01 to 0.64; RD -0.56, 95% CI -0.84 to -0.27; NNTB 2, 95% CI 1 to 4). Thermal (transwarmer) mattress significantly kept infants ≤ 1500 grams warmer (MD 0.65°C, 95% CI 0.36 to 0.94) and reduced the incidence of hypothermia on admission to the NICU, with no significant difference in hyperthermia risk.Combinations of interventionsTwo studies (77 infants) compared thermal mattresses versus plastic wraps or bags for infants at ≤ 28 weeks' gestation. Investigators reported no significant differences in core body temperature nor in the incidence of hypothermia, hyperthermia, or core body temperature outside the normothermic range on admission to the NICU.Two additional studies (119 infants) compared plastic bags and thermal mattresses versus plastic bags alone for infants at < 31 weeks' gestation. Meta-analysis of these two studies showed improvement in core body temperature on admission to the NICU or up to two hours after birth, but an increase in hyperthermia. Data show no significant difference in the risk of having a core body temperature outside the normothermic range on admission to the NICU nor in the risk of other reported morbidities.
AUTHORS' CONCLUSIONS
Evidence of moderate quality shows that use of plastic wraps or bags compared with routine care led to higher temperatures on admission to NICUs with less hypothermia, particularly for extremely preterm infants. Thermal mattresses and SSC also reduced hypothermia risk when compared with routine care, but findings are based on two or fewer small studies. Caution must be taken to avoid iatrogenic hyperthermia, particularly when multiple interventions are used simultaneously. Limited evidence suggests benefit and no evidence of harm for most short-term morbidity outcomes known to be associated with hypothermia, including major brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotising enterocolitis, and nosocomial infection. Many observational studies have shown increased mortality among preterm hypothermic infants compared with those who maintain normothermia, yet evidence is insufficient to suggest that these interventions reduce risk of in-hospital mortality across all comparison groups. Hypothermia may be a marker for illness and poorer outcomes by association rather than by causality. Limitations of this review include small numbers of identified studies; small sample sizes; and variations in methods and definitions used for hypothermia, hyperthermia, normothermia, routine care, and morbidity, along with lack of power to detect effects on morbidity and mortality across most comparison groups. Future studies should: be adequately powered to detect rarer outcomes; apply standardised morbidity definitions; focus on longer-term outcomes, particularly neurodevelopmental outcomes.
Topics: Humans; Hypothermia; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Perinatal Care; Randomized Controlled Trials as Topic
PubMed: 29431872
DOI: 10.1002/14651858.CD004210.pub5 -
BMC Pregnancy and Childbirth Oct 2023Skin-to-skin contact between mother and infant after birth is recommended to promote breastfeeding and maternal-infant bonding. However, its impact on the incidence of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Skin-to-skin contact between mother and infant after birth is recommended to promote breastfeeding and maternal-infant bonding. However, its impact on the incidence of neonatal hypoglycaemia is unknown. We conducted a systematic review and meta-analysis to assess this.
METHODS
Published randomised control trials (RCTs), quasi-RCTs, non-randomised studies of interventions, cohort, or case-control studies with an intervention of skin-to-skin care compared to other treatment were included without language or date restrictions. The primary outcome was neonatal hypoglycaemia (study-defined). We searched 4 databases and 4 trial registries from inception to May 12, 2023. Quality of studies was assessed using Cochrane Risk of Bias 1 or Effective Public Health Practice Project Quality Assessment tools. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results were synthesised using RevMan 5.4.1 or STATA and analysed using random-effects meta-analyses where possible, otherwise with direction of findings tables. This review was registered prospectively on PROSPERO (CRD42022328322).
RESULTS
This review included 84,900 participants in 108 studies, comprising 65 RCTs, 16 quasi-RCTs, seven non-randomised studies of intervention, eight prospective cohort studies, nine retrospective cohort studies and three case-control studies. Evidence suggests skin-to-skin contact may result in a large reduction in the incidence of neonatal hypoglycaemia (7 RCTs/quasi-RCTs, 922 infants, RR 0.29 (0.13, 0.66), p < 0.0001, I = 47%). Skin-to-skin contact may reduce the incidence of admission to special care or neonatal intensive care nurseries for hypoglycaemia (1 observational study, 816 infants, OR 0.50 (0.25-1.00), p = 0.050), but the evidence is very uncertain. Skin-to-skin contact may reduce duration of initial hospital stay after birth (31 RCTs, 3437 infants, MD -2.37 (-3.66, -1.08) days, p = 0.0003, I = 90%, p for Egger's test = 0.02), and increase exclusive breastmilk feeding from birth to discharge (1 observational study, 1250 infants, RR 4.30 (3.19, 5.81), p < 0.0001), but the evidence is very uncertain.
CONCLUSION
Skin-to-skin contact may lead to a large reduction in the incidence of neonatal hypoglycaemia. This, along with other established benefits, supports the practice of skin-to-skin contact for all infants and especially those at risk of hypoglycaemia.
Topics: Infant, Newborn; Infant; Female; Humans; Breast Feeding; Mothers; Fetal Diseases; Hypoglycemia; Case-Control Studies; Observational Studies as Topic
PubMed: 37865757
DOI: 10.1186/s12884-023-06057-8 -
BMJ Clinical Evidence Apr 2011Over 85% of women having a vaginal birth suffer some perineal trauma. Spontaneous tears requiring suturing are estimated to occur in at least a third of women in the UK... (Review)
Review
INTRODUCTION
Over 85% of women having a vaginal birth suffer some perineal trauma. Spontaneous tears requiring suturing are estimated to occur in at least a third of women in the UK and US, with anal sphincter tears in 0.5% to 7% of women. Perineal trauma can lead to long-term physical and psychological problems.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of intrapartum surgical and non-surgical interventions on rates of perineal trauma? What are the effects of different methods and materials for primary repair of first- and second-degree tears and episiotomies? What are the effects of different methods and materials for primary repair of obstetric anal sphincter injuries (third- and fourth-degree tears)? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 38 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: active pushing, spontaneous pushing, and sustained breath-holding (Valsalva) method of pushing; continuous support during labour; conventional suturing; different methods and materials for primary repair of obstetric anal sphincter injuries; episiotomies (midline and mediolateral incisions); epidural analgesia; forceps; methods of delivery ("hands-on" method, "hands poised"); water births; non-suturing of muscle and skin (or perineal skin alone); passive descent in the second stage of labour; positions (supine or lithotomy positions, upright position during delivery); restrictive or routine use of episiotomy; sutures (absorbable synthetic sutures, catgut sutures, continuous sutures, interrupted sutures); and vacuum extraction.
Topics: Analgesia, Epidural; Humans; Labor, Obstetric; Parturition; Perineum; Suture Techniques; Sutures; Vacuum Extraction, Obstetrical; Wound Healing
PubMed: 21481287
DOI: No ID Found -
Behavioral Sciences (Basel, Switzerland) Jan 2024A series of studies have shown that mothers' early tactile behaviors have positive effects, both on full-term and preterm infants, and on mothers alike. Regarding... (Review)
Review
A series of studies have shown that mothers' early tactile behaviors have positive effects, both on full-term and preterm infants, and on mothers alike. Regarding fathers, research has focused mostly on paternal skin-to-skin care with preterm infants and has overlooked the tactile behavior effects with full-term newborns on infants' outcomes and on fathers themselves. The current systematic review considered the evidence regarding paternal tactile behaviors with full-term infants, including skin-to-skin care (SSC) and spontaneous touch (ST), during parent-infant interactions, and differentiated biophysiological, behavioral and psychological variables both in fathers and in infants. We also compared fathers' and mothers' tactile behaviors for potential differences. The few available studies suggest that paternal touch-SSC and ST-can have positive effects on fathers and infants alike. They also show that, despite some intrinsic differences, paternal touch is as pleasant as maternal touch. However, given the paucity of studies on the topic, we discuss why this field of research should be further explored.
PubMed: 38247712
DOI: 10.3390/bs14010060 -
The Cochrane Database of Systematic... Aug 2019Hospital-acquired infection is a frequent adverse event in patient care; it can lead to longer stays in the intensive care unit (ICU), additional medical complications,...
BACKGROUND
Hospital-acquired infection is a frequent adverse event in patient care; it can lead to longer stays in the intensive care unit (ICU), additional medical complications, permanent disability or death. Whilst all hospital-based patients are susceptible to infections, prevalence is particularly high in the ICU, where people who are critically ill have suppressed immunity and are subject to increased invasive monitoring. People who are mechanically-ventilated are at infection risk due to tracheostomy and reintubation and use of multiple central venous catheters, where lines and tubes may act as vectors for the transmission of bacteria and may increase bloodstream infections and ventilator-associated pneumonia (VAP). Chlorhexidine is a low-cost product, widely used as a disinfectant and antiseptic, which may be used to bathe people who are critically ill with the aim of killing bacteria and reducing the spread of hospital-acquired infections.
OBJECTIVES
To assess the effects of chlorhexidine bathing on the number of hospital-acquired infections in people who are critically ill.
SEARCH METHODS
In December 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trial registries for ongoing and unpublished studies, and checked reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that compared chlorhexidine bathing with soap-and-water bathing of patients in the ICU.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility, extracted data and undertook risk of bias and GRADE assessment of the certainty of the evidence .
MAIN RESULTS
We included eight studies in this review. Four RCTs included a total of 1537 individually randomised participants, and four cluster-randomised cross-over studies included 23 randomised ICUs with 22,935 participants. We identified one study awaiting classification, for which we were unable to assess eligibility.The studies compared bathing using 2% chlorhexidine-impregnated washcloths or dilute solutions of 4% chlorhexidine versus soap-and-water bathing or bathing with non-antimicrobial washcloths.Eight studies reported data for participants who had a hospital-acquired infection during the ICU stay. We are uncertain whether using chlorhexidine for bathing of critically ill people reduces the rate of hospital-acquired infection, because the certainty of the evidence is very low (rate difference 1.70, 95% confidence interval (CI) 0.12 to 3.29; 21,924 participants). Six studies reported mortality (in hospital, in the ICU, and at 48 hours). We cannot be sure whether using chlorhexidine for bathing of critically-ill people reduces mortality, because the certainty of the evidence is very low (odds ratio 0.87, 95% CI 0.76 to 0.99; 15,798 participants). Six studies reported length of stay in the ICU. We noted that individual studies found no evidence of a difference in length of stay; we did not conduct meta-analysis because data were skewed. It is not clear whether using chlorhexidine for bathing of critically ill people reduced length of stay in the ICU, because the certainty of the evidence is very low. Seven studies reported skin reactions as an adverse event, and five of these reported skin reactions which were thought to be attributable to the bathing solution. Data in these studies were reported inconsistently and we were unable to conduct meta-analysis; we cannot tell whether using chlorhexidine for bathing of critically ill people reduced adverse events, because the certainty of the evidence is very low.We used the GRADE approach to downgrade the certainty of the evidence of each outcome to very low. For all outcomes, we downgraded evidence because of study limitations (most studies had a high risk of performance bias, and we noted high risks of other bias in some studies). We downgraded evidence due to indirectness, because some participants in studies may have had hospital-acquired infections before recruitment. We noted that one small study had a large influence on the effect for hospital-acquired infections, and we assessed decisions made in analysis of some cluster-randomised cross-over studies on the effect for hospital-acquired infections and for mortality; we downgraded the evidence for these outcomes due to inconsistency. We also downgraded the evidence on length of stay in the ICU, because of imprecision. Data for adverse events were limited by few events and so we downgraded for imprecision.
AUTHORS' CONCLUSIONS
Due to the very low-certainty evidence available, it is not clear whether bathing with chlorhexidine reduces hospital-acquired infections, mortality, or length of stay in the ICU, or whether the use of chlorhexidine results in more skin reactions.
Topics: Anti-Infective Agents, Local; Baths; Central Venous Catheters; Chlorhexidine; Critical Illness; Cross Infection; Humans; Pneumonia, Ventilator-Associated; Randomized Controlled Trials as Topic; Sepsis
PubMed: 31476022
DOI: 10.1002/14651858.CD012248.pub2 -
BMJ Clinical Evidence Mar 2008Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers in up to a third of people in hospitals or community care,... (Review)
Review
INTRODUCTION
Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers in up to a third of people in hospitals or community care, and a fifth of nursing home residents. Pressure ulcers are more likely in people with reduced mobility and poor skin condition, such as older people or those with vascular disease.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of preventive interventions in people at risk of developing pressure ulcers? What are the effects of treatments in people with pressure ulcers? We searched: Medline, Embase, The Cochrane Library and other important databases up to February 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 60 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: air-filled vinyl boots, air-fluidised supports, alternating pressure surfaces (including mattresses), alternative foam mattresses, constant low-pressure supports, debridement, electric profiling beds, electrotherapy, hydrocellular heel supports, low-air-loss beds (including hydrotherapy beds), low-level laser therapy, low-tech constant low-pressure supports, medical sheepskin overlays, nutritional supplements, orthopaedic wool padding, pressure-relieving overlays on operating tables, pressure-relieving surfaces, repositioning (regular "turning"), seat cushions, standard beds, standard care, standard foam mattresses, standard tables, surgery, therapeutic ultrasound, topical lotions and dressings, topical negative pressure, and topical phenytoin.
Topics: Animals; Bandages; Beds; Humans; Low-Level Light Therapy; Negative-Pressure Wound Therapy; Phenytoin; Pressure Ulcer
PubMed: 19450317
DOI: No ID Found -
The Cochrane Database of Systematic... Dec 2018Pressure ulcers, localised injuries to the skin or underlying tissue, or both, occur when people cannot reposition themselves to relieve pressure on bony prominences.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pressure ulcers, localised injuries to the skin or underlying tissue, or both, occur when people cannot reposition themselves to relieve pressure on bony prominences. These wounds are difficult to heal, painful, expensive to manage and have a negative impact on quality of life. Prevention strategies include nutritional support and pressure redistribution. Dressing and topical agents aimed at prevention are also widely used, however, it remains unclear which, if any, are most effective. This is the first update of this review, which was originally published in 2013.
OBJECTIVES
To evaluate the effects of dressings and topical agents on pressure ulcer prevention, in people of any age, without existing pressure ulcers, but considered to be at risk of developing one, in any healthcare setting.
SEARCH METHODS
In March 2017 we searched the Cochrane Wounds Group Specialised Register, CENTRAL, MEDLINE, MEDLINE (In-Process & Other Non-Indexed Citations), Embase, and EBSCO CINAHL Plus. We searched clinical trials registries for ongoing trials, and bibliographies of relevant publications to identify further eligible trials. There was no restriction on language, date of trial or setting. In May 2018 we updated this search; as a result several trials are awaiting classification.
SELECTION CRITERIA
We included randomised controlled trials that enrolled people at risk of pressure ulcers.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, assessed risk of bias and extracted data.
MAIN RESULTS
The original search identified nine trials; the updated searches identified a further nine trials meeting our inclusion criteria. Of the 18 trials (3629 participants), nine involved dressings; eight involved topical agents; and one included dressings and topical agents. All trials reported the primary outcome of pressure ulcer incidence.Topical agentsThere were five trials comparing fatty acid interventions to different treatments. Two trials compared fatty acid to olive oil. Pooled evidence shows that there is no clear difference in pressure ulcer incidence between groups, fatty acid versus olive oil (2 trials, n=1060; RR 1.28, 95% CI 0.76 to 2.17; low-certainty evidence, downgraded for very serious imprecision; or fatty acid versus standard care (2 trials, n=187; RR 0.70, 95% CI 0.41 to 1.18; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Trials reported that pressure ulcer incidence was lower with fatty acid-containing-treatment compared with a control compound of trisostearin and perfume (1 trial, n=331; RR 0.42, 95% CI 0.22 to 0.80; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Pooled evidence shows that there is no clear difference in incidence of adverse events between fatty acids and olive oil (1 trial, n=831; RR 2.22 95% CI 0.20 to 24.37; low-certainty evidence, downgraded for very serious imprecision).Four trials compared further different topical agents with placebo. Dimethyl sulfoxide (DMSO) cream may increase the risk of pressure ulcer incidence compared with placebo (1 trial, n=61; RR 1.99, 95% CI 1.10 to 3.57; low-certainty evidence; downgraded for serious risk of bias and serious imprecision). The other three trials reported no clear difference in pressure ulcer incidence between active topical agents and control/placebo; active lotion (1 trial, n=167; RR 0.73, 95% CI 0.45 to 1.19), Conotrane (1 trial, n=258; RR 0.74, 95% CI 0.52 to 1.07), Prevasore (1 trial, n=120; RR 0.33, 95% CI 0.04 to 3.11) (very low-certainty evidence, downgraded for very serious risk of bias and very serious imprecision). There was limited evidence from one trial to determine whether the application of a topical agent may delay or prevent the development of a pressure ulcer (Dermalex 9.8 days vs placebo 8.7 days). Further, two out of 76 reactions occurred in the Dermalex group compared with none out of 91 in the placebo group (RR 6.14, 95% CI 0.29 to 129.89; very low-certainty evidence; downgraded for very serious risk of bias and very serious imprecision).DressingsSix trials (n = 1247) compared a silicone dressing with no dressing. Silicone dressings may reduce pressure ulcer incidence (any stage) (RR 0.25, 95% CI 0.16 to 0.41; low-certainty evidence; downgraded for very serious risk of bias). In the one trial (n=77) we rated as being at low risk of bias, there was no clear difference in pressure ulcer incidence between silicone dressing and placebo-treated groups (RR 1.95, 95% CI 0.18 to 20.61; low-certainty evidence, downgraded for very serious imprecision).One trial (n=74) reported no clear difference in pressure ulcer incidence when a thin polyurethane dressing was compared with no dressing (RR 1.31, 95% CI 0.83 to 2.07). In the same trial pressure ulcer incidence was reported to be higher in an adhesive foam dressing compared with no dressing (RR 1.65, 95% CI 1.10 to 2.48). We rated evidence from this trial as very low certainty (downgraded for very serious risk of bias and serious imprecision).Four trials compared other dressings with different controls. Trials reported that there was no clear difference in pressure ulcer incidence between the following comparisons: polyurethane film and hydrocolloid dressing (n=160, RR 0.58, 95% CI 0.24 to 1.41); Kang' huier versus routine care n=100; RR 0.42, 95% CI 0.08 to 2.05); 'pressure ulcer preventive dressing' (PPD) versus no dressing (n=74; RR 0.18, 95% CI 0.04 to 0.76) We rated the evidence as very low certainty (downgraded for very serious risk of bias and serious or very serious imprecision).
AUTHORS' CONCLUSIONS
Most of the trials exploring the impact of topical applications on pressure ulcer incidence showed no clear benefit or harm. Use of fatty acid versus a control compound (a cream that does not include fatty acid) may reduce the incidence of pressure ulcers. Silicone dressings may reduce pressure ulcer incidence (any stage). However the low level of evidence certainty means that additional research is required to confirm these results.
Topics: Administration, Cutaneous; Aged; Allantoin; Bandages; Dimethyl Sulfoxide; Drug Administration Schedule; Drug Combinations; Fatty Acids; Hexachlorophene; Humans; Incidence; Middle Aged; Olive Oil; Pressure Ulcer; Randomized Controlled Trials as Topic; Silicones; Skin Care; Skin Cream; Squalene
PubMed: 30537080
DOI: 10.1002/14651858.CD009362.pub3 -
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 -
Health Technology Assessment... Jan 2024Atopic dermatitis is a chronic relapsing inflammatory skin condition. One of the most common skin disorders in children, atopic dermatitis typically manifests before the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Atopic dermatitis is a chronic relapsing inflammatory skin condition. One of the most common skin disorders in children, atopic dermatitis typically manifests before the age of 5 years, but it can develop at any age. Atopic dermatitis is characterised by dry, inflamed skin accompanied by intense itchiness (pruritus).
OBJECTIVES
To appraise the clinical and cost effectiveness of abrocitinib, tralokinumab and upadacitinib within their marketing authorisations as alternative therapies for treating moderate-to-severe atopic dermatitis compared to systemic immunosuppressants (first-line ciclosporin A or second-line dupilumab and baricitinib).
DATA SOURCES
Studies were identified from an existing systematic review (search date 2019) and update searches of electronic databases (MEDLINE, EMBASE, CENTRAL) to November 2021, from bibliographies of retrieved studies, clinical trial registers and evidence provided by the sponsoring companies of the treatments under review.
METHODS
A systematic review of the clinical effectiveness literature was carried out and a network meta-analysis undertaken for adults and adolescents at different steps of the treatment pathway. The primary outcome of interest was a combined response of Eczema Area and Severity Index 50 + Dermatology Life Quality Index ≥ 4; where this was consistently unavailable for a step in the pathway, an analysis of Eczema Area and Severity Index 75 was conducted. A de novo economic model was developed to assess cost effectiveness from the perspective of the National Health Service in England. The model structure was informed through systematic review of the economic literature and by consulting clinical experts. Effectiveness data were obtained from the network meta-analysis. Costs and utilities were obtained from the evidence provided by sponsoring companies and standard UK sources.
RESULTS
Network meta-analyses indicate that abrocitinib 200 mg and upadacitinib 30 mg may be more effective, and tralokinumab may be less effective than dupilumab and baricitinib as second-line systemic therapies. Abrocitinib 100 mg and upadacitinib 15 mg have a more similar effectiveness to dupilumab. Upadacitinib 30 and 15 mg are likely to be more effective than ciclosporin A as a first-line therapy. Upadacitinib 15 mg, abrocitinib 200 and 100 mg may be more effective than dupilumab in adolescents. The cost effectiveness of abrocitinib and upadacitinib for both doses is dependent on the subgroup of interest. Tralokinumab can be considered cost-effective as a second-line systemic therapy owing to greater cost savings per quality-adjusted life-year lost.
CONCLUSIONS
The primary strength of the analysis of the three new drugs compared with current practice for each of the subpopulations is the consistent approach to the assessment of clinical and cost effectiveness. However, the conclusions are limited by the high uncertainty around the clinical effectiveness and lack of data for the primary outcome for comparisons with baricitinib and for the adolescent and adult first-line populations.
FUTURE WORK AND LIMITATIONS
The most significant limitation that Eczema Area and Severity Index 50 + Dermatology Life Quality Index ≥ 4 could not be obtained for the adolescent and adult first-line systemic treatment populations is due to a paucity of data for dupilumab and ciclosporin A. A comparison of the new drugs against one another in addition to current practice would be beneficial to provide a robust view on which treatments are the most cost-effective.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42021266219.
FUNDING
This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: 135138) and is published in full in ; Vol. 28, No. 4. See the NIHR Funding and Awards website for further award information.
Topics: Child; Adult; Adolescent; Humans; Child, Preschool; Dermatitis, Atopic; Cyclosporine; State Medicine; Treatment Outcome; Cost-Benefit Analysis; Eczema; Antibodies, Monoclonal; Purines; Heterocyclic Compounds, 3-Ring; Sulfonamides; Pyrazoles; Pyrimidines; Azetidines
PubMed: 38343072
DOI: 10.3310/LEXB9006