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Midwifery Jan 2018to identify what skin practices are important for the protection of baby skin in healthy term babies (0-6 months) and generate evidence-based conclusions to inform... (Review)
Review
OBJECTIVES
to identify what skin practices are important for the protection of baby skin in healthy term babies (0-6 months) and generate evidence-based conclusions to inform health professionals and parents.
DESIGN
eleven databases were searched for all empirical quantitative and qualitative research published between 2000-2015 which explored baby skin care for bathing and cleansing, nappy care, hair and scalp care, management of dry skin or baby massage, for healthy term babies up to 6 months old. Papers not published in English were excluded. A total of 3062 papers were identified. Pairs of reviewers assessed all citations and extracted data independently. There were 26 included papers: 16 RCTs, 3 non-randomised experimental studies, 1 mixed-methods study and 6 qualitative studies. Primary and secondary outcome measures were analysed using meta-analysis or narrative descriptive statistics. Synthesis of qualitative data was not possible due to disparity of the evidence.
FINDINGS
from the small numbers of studies with comparable data, there was no evidence of any significant differences between tested wash products and water or tested baby wipes and water. There was some evidence to suggest that daily use of full-body emollient therapy may help to reduce the risk of atopic eczema in high risk babies with a genetic predisposition to eczema; however, the use of olive oil or sunflower oil for baby dry skin may adversely affect skin barrier function. There was no evidence about hair/scalp care or baby massage. Qualitative research indicates that parents and health professionals believe that water alone is best.
KEY CONCLUSIONS
meta-analysis was restricted due to the lack of consistency of study outcome measures. Although there is considerable RCT evidence comparing the use of specific products against water alone, or another product, for bathing, cleansing and nappy care, the power of this evidence is reduced due to inconsistency of outcome measures in terms of outcome, treatment site or time-point. The development of a core outcome measure set is advocated for trials assessing skin care practices.
IMPLICATIONS FOR PRACTICE
this review offers health professionals best evidence available on which to base their advice. Of those studies with comparative outcomes, the evidence indicates no difference between the specific products tested and water alone; offering parents a choice in their baby skin care regimen. Protocol available: http://www.crd.york.ac.uk/PROSPEROFILES/28054_PROTOCOL_20151009.pdf.
Topics: Baths; Female; Hair; Humans; Infant; Infant Care; Infant, Newborn; Outcome Assessment, Health Care; Pregnancy; Skin Care
PubMed: 29055852
DOI: 10.1016/j.midw.2017.10.001 -
International Journal of Nursing Studies Feb 2020The increasing numbers of surgeries involving high risk, multi-morbid patients, coupled with inconsistencies in the practice of perioperative surgical wound care,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The increasing numbers of surgeries involving high risk, multi-morbid patients, coupled with inconsistencies in the practice of perioperative surgical wound care, increases patients' risk of surgical site infection and other wound complications.
OBJECTIVES
To synthesise and evaluate the recommendations for nursing practice and research from published systematic reviews in the Cochrane Library on nurse-led preoperative prophylaxis and postoperative surgical wound care interventions used or initiated by nurses.
DESIGN
Meta-review, guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
DATA SOURCES
The Cochrane Library database.
REVIEW METHODS
All Cochrane Systematic Reviews were eligible. Two reviewers independently selected the reviews and extracted data. One reviewer appraised the methodological quality of the included reviews using A MeaSurement Tool to Assess Systematic Reviews 2 checklist. A second reviewer independently verified these appraisals. The review protocol was registered with the Prospective Register of Systematic Reviews.
RESULTS
Twenty-two Cochrane reviews met the inclusion criteria. Of these, 11 reviews focused on preoperative interventions to prevent infection, while 12 focused on postoperative interventions (one review assessed both pre-postoperative interventions). Across all reviews, 14 (63.6%) made at least one recommendation to undertake a specific practice, while two reviews (9.1%) made at least one specific recommendation not to undertake a practice. In relation to recommendations for further research, insufficient sample size was the most predominant methodological issue (12/22) identified across reviews.
CONCLUSIONS
The limited number of recommendations for pre-and-postoperative interventions reflects the paucity of high-quality evidence, suggesting a need for rigorous trials to address these evidence gaps in fundamentals of nursing care.
Topics: Humans; Postoperative Care; Preoperative Care; Surgical Wound; Surgical Wound Infection
PubMed: 31810020
DOI: 10.1016/j.ijnurstu.2019.103486 -
Taiwanese Journal of Obstetrics &... Jan 2019Breast-feeding initiation within the first half hour after birth is one of the World Health Organization recommendations. However, in most hospitals, mother-infant... (Meta-Analysis)
Meta-Analysis
Breast-feeding initiation within the first half hour after birth is one of the World Health Organization recommendations. However, in most hospitals, mother-infant contact and breast-feeding initiation are delayed due to routine mother and infant care. This study aimed to determine the effect of mother-infant skin to skin contact (SSC) immediately after birth on the success rate and duration of the first breast-feeding. In this review, databases of PubMed, Scopus, Cochrane, Google Scholar, SID and Magiran and reference sections of relevant articles were searched for both Persian and English randomized clinical trials from 2000 to December 2017, using the keywords of "(Breast-feeding OR Lactation) AND (mother-infant SSC OR KMC) AND (breast-feeding success OR breast-feeding duration)". A total of nine trials were ultimately included. Data analysis was performed with Comprehensive Meta-analysis (CMA) software version 2. In total 597 participants were assigned to the intervention group and 553 participants were assigned to the comparison group. Quantitative analysis Based on mean differences or odds ratio showed that Mother-Infant SSC had a significantly positive effect on success in first breast-feeding (MD:1.90, 95%; CI 0.958-2.856; p = 0.00, OR: 2.771 95%; CI 1.587-4.838; p = 0.00) and first breast-feeding duration (MD:26.627 95%; CI 1.070-52.184; p = 0.041). Mother-infant SSC after birth has beneficial effects on breast-feeding and can increase the success rate and duration of the first lactation. Therefore, the results of this study can be used by healthcare providers in evidence-based decision-making about ways to increase breast-feeding rates.
Topics: Breast Feeding; Female; Humans; Infant, Newborn; Kangaroo-Mother Care Method; Lactation; Mothers; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 30638460
DOI: 10.1016/j.tjog.2018.11.002 -
The Cochrane Database of Systematic... May 2015More than one in five patients who undergo treatment for breast cancer will develop breast cancer-related lymphedema (BCRL). BCRL can occur as a result of breast cancer... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
More than one in five patients who undergo treatment for breast cancer will develop breast cancer-related lymphedema (BCRL). BCRL can occur as a result of breast cancer surgery and/or radiation therapy. BCRL can negatively impact comfort, function, and quality of life (QoL). Manual lymphatic drainage (MLD), a type of hands-on therapy, is frequently used for BCRL and often as part of complex decongestive therapy (CDT). CDT is a fourfold conservative treatment which includes MLD, compression therapy (consisting of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises (LREs). Phase 1 of CDT is to reduce swelling; Phase 2 is to maintain the reduced swelling.
OBJECTIVES
To assess the efficacy and safety of MLD in treating BCRL.
SEARCH METHODS
We searched Medline, EMBASE, CENTRAL, WHO ICTRP (World Health Organization's International Clinical Trial Registry Platform), and Cochrane Breast Cancer Group's Specialised Register from root to 24 May 2013. No language restrictions were applied.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) or quasi-RCTs of women with BCRL. The intervention was MLD. The primary outcomes were (1) volumetric changes, (2) adverse events. Secondary outcomes were (1) function, (2) subjective sensations, (3) QoL, (4) cost of care.
DATA COLLECTION AND ANALYSIS
We collected data on three volumetric outcomes. (1) LE (lymphedema) volume was defined as the amount of excess fluid left in the arm after treatment, calculated as volume in mL of affected arm post-treatment minus unaffected arm post-treatment. (2) Volume reduction was defined as the amount of fluid reduction in mL from before to after treatment calculated as the pretreatment LE volume of the affected arm minus the post-treatment LE volume of the affected arm. (3) Per cent reduction was defined as the proportion of fluid reduced relative to the baseline excess volume, calculated as volume reduction divided by baseline LE volume multiplied by 100. We entered trial data into Review Manger 5.2 (RevMan), pooled data using a fixed-effect model, and analyzed continuous data as mean differences (MDs) with 95% confidence intervals (CIs). We also explored subgroups to determine whether mild BCRL compared to moderate or severe BCRL, and BCRL less than a year compared to more than a year was associated with a better response to MLD.
MAIN RESULTS
Six trials were included. Based on similar designs, trials clustered in three categories.(1) MLD + standard physiotherapy versus standard physiotherapy (one trial) showed significant improvements in both groups from baseline but no significant between-groups differences for per cent reduction.(2) MLD + compression bandaging versus compression bandaging (two trials) showed significant per cent reductions of 30% to 38.6% for compression bandaging alone, and an additional 7.11% reduction for MLD (MD 7.11%, 95% CI 1.75% to 12.47%; two RCTs; 83 participants). Volume reduction was borderline significant (P = 0.06). LE volume was not significant. Subgroup analyses was significant showing that participants with mild-to-moderate BCRL were better responders to MLD than were moderate-to-severe participants.(3) MLD + compression therapy versus nonMLD treatment + compression therapy (three trials) were too varied to pool. One of the trials compared compression sleeve plus MLD to compression sleeve plus pneumatic pump. Volume reduction was statistically significant favoring MLD (MD 47.00 mL, 95% CI 15.25 mL to 78.75 mL; 1 RCT; 24 participants), per cent reduction was borderline significant (P=0.07), and LE volume was not significant. A second trial compared compression sleeve plus MLD to compression sleeve plus self-administered simple lymphatic drainage (SLD), and was significant for MLD for LE volume (MD -230.00 mL, 95% CI -450.84 mL to -9.16 mL; 1 RCT; 31 participants) but not for volume reduction or per cent reduction. A third trial of MLD + compression bandaging versus SLD + compression bandaging was not significant (P = 0.10) for per cent reduction, the only outcome measured (MD 11.80%, 95% CI -2.47% to 26.07%, 28 participants).MLD was well tolerated and safe in all trials.Two trials measured function as range of motion with conflicting results. One trial reported significant within-groups gains for both groups, but no between-groups differences. The other trial reported there were no significant within-groups gains and did not report between-groups results. One trial measured strength and reported no significant changes in either group.Two trials measured QoL, but results were not usable because one trial did not report any results, and the other trial did not report between-groups results.Four trials measured sensations such as pain and heaviness. Overall, the sensations were significantly reduced in both groups over baseline, but with no between-groups differences. No trials reported cost of care.Trials were small ranging from 24 to 45 participants. Most trials appeared to randomize participants adequately. However, in four trials the person measuring the swelling knew what treatment the participants were receiving, and this could have biased results.
AUTHORS' CONCLUSIONS
MLD is safe and may offer additional benefit to compression bandaging for swelling reduction. Compared to individuals with moderate-to-severe BCRL, those with mild-to-moderate BCRL may be the ones who benefit from adding MLD to an intensive course of treatment with compression bandaging. This finding, however, needs to be confirmed by randomized data.In trials where MLD and sleeve were compared with a nonMLD treatment and sleeve, volumetric outcomes were inconsistent within the same trial. Research is needed to identify the most clinically meaningful volumetric measurement, to incorporate newer technologies in LE assessment, and to assess other clinically relevant outcomes such as fibrotic tissue formation.Findings were contradictory for function (range of motion), and inconclusive for quality of life.For symptoms such as pain and heaviness, 60% to 80% of participants reported feeling better regardless of which treatment they received.One-year follow-up suggests that once swelling had been reduced, participants were likely to keep their swelling down if they continued to use a custom-made sleeve.
Topics: Bandages; Breast Neoplasms; Drainage; Female; Humans; Lymphedema; Massage; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 25994425
DOI: 10.1002/14651858.CD003475.pub2 -
Journal of Global Health Jun 2016Kangaroo mother care (KMC), often defined as skin-to-skin contact between a mother and her newborn, frequent or exclusive breastfeeding, and early discharge from the... (Review)
Review
BACKGROUND
Kangaroo mother care (KMC), often defined as skin-to-skin contact between a mother and her newborn, frequent or exclusive breastfeeding, and early discharge from the hospital has been effective in reducing the risk of mortality among preterm and low birth weight infants. Research studies and program implementation of KMC have used various definitions.
OBJECTIVES
To describe the current definitions of KMC in various settings, analyze the presence or absence of KMC components in each definition, and present a core definition of KMC based on common components that are present in KMC literature.
METHODS
We conducted a systematic review and searched PubMed, Embase, Scopus, Web of Science, and the World Health Organization Regional Databases for studies with key words "kangaroo mother care", "kangaroo care" or "skin to skin care" from 1 January 1960 to 24 April 2014. Two independent reviewers screened articles and abstracted data.
FINDINGS
We screened 1035 articles and reports; 299 contained data on KMC and neonatal outcomes or qualitative information on KMC implementation. Eighty-eight of the studies (29%) did not define KMC. Two hundred and eleven studies (71%) included skin-to-skin contact (SSC) in their KMC definition, 49 (16%) included exclusive or nearly exclusive breastfeeding, 22 (7%) included early discharge criteria, and 36 (12%) included follow-up after discharge. One hundred and sixty-seven studies (56%) described the duration of SSC.
CONCLUSIONS
There exists significant heterogeneity in the definition of KMC. A large number of studies did not report definitions of KMC. Skin-to-skin contact is the core component of KMC, whereas components such as breastfeeding, early discharge, and follow-up care are context specific. To implement KMC effectively development of a global standardized definition of KMC is needed.
Topics: Adult; Attitude to Health; Female; Humans; Infant; Infant, Newborn; Kangaroo-Mother Care Method; Mothers; Physical Stimulation
PubMed: 27231546
DOI: 10.7189/jogh.06.010701 -
International Journal of Environmental... Apr 2021Several studies have focused on neonatal maternal separation (MS) to investigate behavioural and neuroendocrine reactions to lack of contact, but only a few have focused... (Review)
Review
Several studies have focused on neonatal maternal separation (MS) to investigate behavioural and neuroendocrine reactions to lack of contact, but only a few have focused on early separation in the first days or weeks after birth. This literature review investigates the vital importance of contact and touch by exploring how skin-to-skin contact (SSC) regulates stress in the mother-infant relationship. Various databases such as PubMed, Scopus, and ScienceDirect were searched for literature published between 2015 and 2020. From 1141 articles, 22 were declared eligible. The reviewed articles showed how SSC regulates child stress by biological indicators such as the autonomic nervous system (ANS), heart rate variability (HRV), cortisol, and oxytocin. This research concludes the importance of SSC for stress regulation, especially during the COVID-19 pandemic. With no research to date indicating a possible risk of neonatal COVID-19 transmission following SSC, SSC should continue to be practiced for all women, as recommended by the WHO.
Topics: COVID-19; Child; Female; Humans; Infant; Kangaroo-Mother Care Method; Maternal Deprivation; Mother-Child Relations; Pandemics; SARS-CoV-2
PubMed: 33924970
DOI: 10.3390/ijerph18094695 -
Diabetes/metabolism Research and Reviews Jan 2016Prevention of foot ulcers in patients with diabetes is extremely important to help reduce the enormous burden of foot ulceration on both patient and health resources. A... (Review)
Review
BACKGROUND
Prevention of foot ulcers in patients with diabetes is extremely important to help reduce the enormous burden of foot ulceration on both patient and health resources. A comprehensive analysis of reported interventions is not currently available, but is needed to better inform caregivers about effective prevention. The aim of this systematic review is to investigate the effectiveness of interventions to prevent first and recurrent foot ulcers in persons with diabetes who are at risk for ulceration.
METHODS
The available medical scientific literature in PubMed, EMBASE, CINAHL and the Cochrane database was searched for original research studies on preventative interventions. Both controlled and non-controlled studies were selected. Data from controlled studies were assessed for methodological quality by two independent reviewers.
RESULTS
From the identified records, a total of 30 controlled studies (of which 19 RCTs) and another 44 non-controlled studies were assessed and described. Few controlled studies, of generally low to moderate quality, were identified on the prevention of a first foot ulcer. For the prevention of recurrent plantar foot ulcers, multiple RCTs with low risk of bias show the benefit for the use of daily foot skin temperature measurements and consequent preventative actions, as well as for therapeutic footwear that demonstrates to relieve plantar pressure and that is worn by the patient. To prevent recurrence, some evidence exists for integrated foot care when it includes a combination of professional foot treatment, therapeutic footwear and patient education; for just a single session of patient education, no evidence exists. Surgical interventions can be effective in selected patients, but the evidence base is small.
CONCLUSION
The evidence base to support the use of specific self-management and footwear interventions for the prevention of recurrent plantar foot ulcers is quite strong, but is small for the use of other, sometimes widely applied, interventions and is practically nonexistent for the prevention of a first foot ulcer and non-plantar foot ulcer.
Topics: Combined Modality Therapy; Cost of Illness; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Foot; Evidence-Based Medicine; Humans; Patient Compliance; Patient Education as Topic; Precision Medicine; Recurrence; Risk Factors; Self Care; Shoes
PubMed: 26340966
DOI: 10.1002/dmrr.2701 -
The Cochrane Database of Systematic... Feb 2021Eczema and food allergy are common health conditions that usually begin in early childhood and often occur together in the same people. They can be associated with an... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Eczema and food allergy are common health conditions that usually begin in early childhood and often occur together in the same people. They can be associated with an impaired skin barrier in early infancy. It is unclear whether trying to prevent or reverse an impaired skin barrier soon after birth is effective in preventing eczema or food allergy.
OBJECTIVES
Primary objective To assess effects of skin care interventions, such as emollients, for primary prevention of eczema and food allergy in infants Secondary objective To identify features of study populations such as age, hereditary risk, and adherence to interventions that are associated with the greatest treatment benefit or harm for both eczema and food allergy.
SEARCH METHODS
We searched the following databases up to July 2020: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, and Embase. We searched two trials registers and checked reference lists of included studies and relevant systematic reviews for further references to relevant randomised controlled trials (RCTs). We contacted field experts to identify planned trials and to seek information about unpublished or incomplete trials.
SELECTION CRITERIA
RCTs of skin care interventions that could potentially enhance skin barrier function, reduce dryness, or reduce subclinical inflammation in healthy term (> 37 weeks) infants (0 to 12 months) without pre-existing diagnosis of eczema, food allergy, or other skin condition were included. Comparison was standard care in the locality or no treatment. Types of skin care interventions included moisturisers/emollients; bathing products; advice regarding reducing soap exposure and bathing frequency; and use of water softeners. No minimum follow-up was required.
DATA COLLECTION AND ANALYSIS
This is a prospective individual participant data (IPD) meta-analysis. We used standard Cochrane methodological procedures, and primary analyses used the IPD dataset. Primary outcomes were cumulative incidence of eczema and cumulative incidence of immunoglobulin (Ig)E-mediated food allergy by one to three years, both measured by the closest available time point to two years. Secondary outcomes included adverse events during the intervention period; eczema severity (clinician-assessed); parent report of eczema severity; time to onset of eczema; parent report of immediate food allergy; and allergic sensitisation to food or inhalant allergen.
MAIN RESULTS
This review identified 33 RCTs, comprising 25,827 participants. A total of 17 studies, randomising 5823 participants, reported information on one or more outcomes specified in this review. Eleven studies randomising 5217 participants, with 10 of these studies providing IPD, were included in one or more meta-analysis (range 2 to 9 studies per individual meta-analysis). Most studies were conducted at children's hospitals. All interventions were compared against no skin care intervention or local standard care. Of the 17 studies that reported our outcomes, 13 assessed emollients. Twenty-five studies, including all those contributing data to meta-analyses, randomised newborns up to age three weeks to receive a skin care intervention or standard infant skin care. Eight of the 11 studies contributing to meta-analyses recruited infants at high risk of developing eczema or food allergy, although definition of high risk varied between studies. Durations of intervention and follow-up ranged from 24 hours to two years. We assessed most of this review's evidence as low certainty or had some concerns of risk of bias. A rating of some concerns was most often due to lack of blinding of outcome assessors or significant missing data, which could have impacted outcome measurement but was judged unlikely to have done so. Evidence for the primary food allergy outcome was rated as high risk of bias due to inclusion of only one trial where findings varied when different assumptions were made about missing data. Skin care interventions during infancy probably do not change risk of eczema by one to two years of age (risk ratio (RR) 1.03, 95% confidence interval (CI) 0.81 to 1.31; moderate-certainty evidence; 3075 participants, 7 trials) nor time to onset of eczema (hazard ratio 0.86, 95% CI 0.65 to 1.14; moderate-certainty evidence; 3349 participants, 9 trials). It is unclear whether skin care interventions during infancy change risk of IgE-mediated food allergy by one to two years of age (RR 2.53, 95% CI 0.99 to 6.47; 996 participants, 1 trial) or allergic sensitisation to a food allergen at age one to two years (RR 0.86, 95% CI 0.28 to 2.69; 1055 participants, 2 trials) due to very low-certainty evidence for these outcomes. Skin care interventions during infancy may slightly increase risk of parent report of immediate reaction to a common food allergen at two years (RR 1.27, 95% CI 1.00 to 1.61; low-certainty evidence; 1171 participants, 1 trial). However, this was only seen for cow's milk, and may be unreliable due to significant over-reporting of cow's milk allergy in infants. Skin care interventions during infancy probably increase risk of skin infection over the intervention period (RR 1.34, 95% CI 1.02 to 1.77; moderate-certainty evidence; 2728 participants, 6 trials) and may increase risk of infant slippage over the intervention period (RR 1.42, 95% CI 0.67 to 2.99; low-certainty evidence; 2538 participants, 4 trials) or stinging/allergic reactions to moisturisers (RR 2.24, 95% 0.67 to 7.43; low-certainty evidence; 343 participants, 4 trials), although confidence intervals for slippages and stinging/allergic reactions are wide and include the possibility of no effect or reduced risk. Preplanned subgroup analyses show that effects of interventions were not influenced by age, duration of intervention, hereditary risk, FLG mutation, or classification of intervention type for risk of developing eczema. We could not evaluate these effects on risk of food allergy. Evidence was insufficient to show whether adherence to interventions influenced the relationship between skin care interventions and risk of developing eczema or food allergy.
AUTHORS' CONCLUSIONS
Skin care interventions such as emollients during the first year of life in healthy infants are probably not effective for preventing eczema, and probably increase risk of skin infection. Effects of skin care interventions on risk of food allergy are uncertain. Further work is needed to understand whether different approaches to infant skin care might promote or prevent eczema and to evaluate effects on food allergy based on robust outcome assessments.
Topics: Bias; Eczema; Emollients; Female; Filaggrin Proteins; Food Hypersensitivity; Humans; Hypersensitivity, Immediate; Immunoglobulin E; Infant; Infant, Newborn; Male; Milk Hypersensitivity; Skin Care; Skin Diseases, Infectious; Soaps
PubMed: 33545739
DOI: 10.1002/14651858.CD013534.pub2 -
The Cochrane Database of Systematic... Mar 2022Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS/TEN overlap syndrome are rare, severe cutaneous adverse reactions usually triggered by... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS/TEN overlap syndrome are rare, severe cutaneous adverse reactions usually triggered by medications. In addition to tertiary-level supportive care, various systemic therapies have been used including glucocorticoids, intravenous immunoglobulins (IVIGs), cyclosporin, N-acetylcysteine, thalidomide, infliximab, etanercept, and plasmapheresis. There is an unmet need to understand the efficacy of these interventions.
OBJECTIVES
To assess the effects of systemic therapies (medicines delivered orally, intramuscularly, or intravenously) for the treatment of SJS, TEN, and SJS/TEN overlap syndrome.
SEARCH METHODS
We searched the following databases up to March 2021: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, and Embase. We also searched five clinical trial registers, the reference lists of all included studies and of key review articles, and a number of drug manufacturer websites. We searched for errata or retractions of included studies.
SELECTION CRITERIA
We included only randomised controlled trials (RCTs) and prospective observational comparative studies of participants of any age with a clinical diagnosis of SJS, TEN, or SJS/TEN overlap syndrome. We included all systemic therapies studied to date and permitted comparisons between each therapy, as well as between therapy and placebo.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures as specified by Cochrane. Our primary outcomes were SJS/TEN-specific mortality and adverse effects leading to discontinuation of SJS/TEN therapy. Secondary outcomes included time to complete re-epithelialisation, intensive care unit length of stay, total hospital length of stay, illness sequelae, and other adverse effects attributed to systemic therapy. We rated the certainty of the evidence for each outcome using GRADE.
MAIN RESULTS
We included nine studies with a total of 308 participants (131 males and 155 females) from seven countries. We included two studies in the quantitative meta-analysis. We included three RCTs and six prospective, controlled observational studies. Sample sizes ranged from 10 to 91. Most studies did not report study duration or time to follow-up. Two studies reported a mean SCORe of Toxic Epidermal Necrosis (SCORTEN) of 3 and 1.9. Seven studies did not report SCORTEN, although four of these studies reported average or ranges of body surface area (BSA) (means ranging from 44% to 51%). Two studies were set in burns units, two in dermatology wards, one in an intensive care unit, one in a paediatric ward, and three in unspecified inpatient units. Seven studies reported a mean age, which ranged from 29 to 56 years. Two studies included paediatric participants (23 children). We assessed the results from one of three RCTs as low risk of bias in all domains, one as high, and one as some concerns. We judged the results from all six prospective observational comparative studies to be at a high risk of bias. We downgraded the certainty of the evidence because of serious risk of bias concerns and for imprecision due to small numbers of participants. The interventions assessed included systemic corticosteroids, tumour necrosis factor-alpha (TNF-alpha) inhibitors, cyclosporin, thalidomide, N-acetylcysteine, IVIG, and supportive care. No data were available for the main comparisons of interest as specified in the review protocol: etanercept versus cyclosporin, etanercept versus IVIG, IVIG versus supportive care, IVIG versus cyclosporin, and cyclosporin versus corticosteroids. Corticosteroids versus no corticosteroids It is uncertain if there is any difference between corticosteroids (methylprednisolone 4 mg/kg/day for two more days after fever had subsided and no new lesions had developed) and no corticosteroids on disease-specific mortality (risk ratio (RR) 2.55, 95% confidence interval (CI) 0.72 to 9.03; 2 studies; 56 participants; very low-certainty evidence). Time to complete re-epithelialisation, length of hospital stay, and adverse effects leading to discontinuation of therapy were not reported. IVIG versus no IVIG It is uncertain if there is any difference between IVIG (0.2 to 0.5 g/kg cumulative dose over three days) and no IVIG in risk of disease-specific mortality (RR 0.33, 95% CI 0.04 to 2.91); time to complete re-epithelialisation (mean difference (MD) -2.93 days, 95% CI -4.4 to -1.46); or length of hospital stay (MD -2.00 days, 95% CI -5.81 to 1.81). All results in this comparison were based on one study with 36 participants, and very low-certainty evidence. Adverse effects leading to discontinuation of therapy were not reported. Etanercept (TNF-alpha inhibitor) versus corticosteroids Etanercept (25 mg (50 mg if weight > 65 kg) twice weekly "until skin lesions healed") may reduce disease-specific mortality compared to corticosteroids (intravenous prednisolone 1 to 1.5 mg/kg/day "until skin lesions healed") (RR 0.51, 95% CI 0.16 to 1.63; 1 study; 91 participants; low-certainty evidence); however, the CIs were consistent with possible benefit and possible harm. Serious adverse events, such as sepsis and respiratory failure, were reported in 5 of 48 participants with etanercept and 9 of 43 participants with corticosteroids, but it was not clear if they led to discontinuation of therapy. Time to complete re-epithelialisation and length of hospital stay were not reported. Cyclosporin versus IVIG It is uncertain if there is any difference between cyclosporin (3 mg/kg/day or intravenous 1 mg/kg/day until complete re-epithelialisation, then tapered off (10 mg/day reduction every 48 hours)) and IVIG (continuous infusion 0.75 g/kg/day for 4 days (total dose 3 g/kg) in participants with normal renal function) in risk of disease-specific mortality (RR 0.13, 95% CI 0.02 to 0.98, 1 study; 22 participants; very low-certainty evidence). Time to complete re-epithelialisation, length of hospital stay, and adverse effects leading to discontinuation of therapy were not reported. No studies measured intensive care unit length of stay.
AUTHORS' CONCLUSIONS
When compared to corticosteroids, etanercept may result in mortality reduction. For the following comparisons, the certainty of the evidence for disease-specific mortality is very low: corticosteroids versus no corticosteroids, IVIG versus no IVIG and cyclosporin versus IVIG. There is a need for more multicentric studies, focused on the most important clinical comparisons, to provide reliable answers about the best treatments for SJS/TEN.
Topics: Acetylcysteine; Adrenal Cortex Hormones; Adult; Autoimmune Diseases; Child; Cyclosporine; Etanercept; Female; Humans; Immunoglobulins, Intravenous; Male; Middle Aged; Observational Studies as Topic; Stevens-Johnson Syndrome; Thalidomide; Tumor Necrosis Factor-alpha
PubMed: 35274741
DOI: 10.1002/14651858.CD013130.pub2 -
Cureus Mar 2023Wound healing poses a variety of challenges making it a vital subject in medicine. With the advancement of science, we have seen the use of a new xenograft known as... (Review)
Review
Wound healing poses a variety of challenges making it a vital subject in medicine. With the advancement of science, we have seen the use of a new xenograft known as acellular fish skin (AFS) grafts that are derived from either Atlantic cod or Nile Tilapia. Fish skin has shown anti-inflammatory and anti-bacterial properties that support and improve wound healing in a variety of wounds including burns and diabetic foot ulcers (DFU). There is ongoing research that evaluates the efficacy of fish skin grafts in comparison to alternative wound healing techniques. A literature search was conducted through the National Library of Medicine with search terms fish skin graft, AFS, xenograft, dehydrated human amnion/chorion, ulcer, burns, and wounds. A total of ten studies that investigate the efficacy of fish skin grafts either in comparison to a different wound healing technique or by simply observing wound healing with fish skin grafts and recording the results were chosen. AFS showed superior healing in comparison to collagen alginate dressings, silver sulfadiazine cream 1%, and allografts. Although there is no one specific gold standard technique for wound healing, fish skin grafts demonstrated overall improved and quicker wound healing, fewer dressing changes, less pain, and lower costs.
PubMed: 37082504
DOI: 10.7759/cureus.36348