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Journal of Plastic, Reconstructive &... Jan 2024Artificial dermal substitutes (ADMs) have been trialled to improve outcomes at the donor site following the harvesting of a radial forearm free flap (RFFF). This...
BACKGROUND
Artificial dermal substitutes (ADMs) have been trialled to improve outcomes at the donor site following the harvesting of a radial forearm free flap (RFFF). This systematic review compares donor site aesthetic and functional outcomes, with the use of an ADM versus conventional practice.
METHODS
The databases Medline, Embase, Cochrane Library, Web of Science (Core Collection), and Scopus were searched for retrospective, prospective, and case-control studies and randomised control trials (RCTs) involving any ADM. Studies with adult patients having undergone RFFF harvesting and donor site repair with an ADM, commenting on appropriate clinical outcomes and without high risk of bias, were included. Direction-of-effect analysis was performed on relevant groupings of studies since heterogeneity in outcome measurement precluded meta-analyses.
RESULTS
Across eight non-comparative studies included, 132 patients had donor site coverage with AlloDerm™, Integra™, Matriderm™, or Rapiderm. Across 11 comparative studies included, 240 patients had donor site coverage with fish-skin matrix, AlloDerm™, amniotic membrane, MegaDerm™, Hyalomatrix, Integra™, or Matriderm™. Five out of 11 comparative studies demonstrated superior aesthetic outcomes with ADMs according to at least one aesthetic metric compared to controls, whilst 6/11 demonstrated superior functional outcomes with ADMs. No study demonstrated poorer aesthetic or functional outcomes with an ADM compared to conventional practice.
CONCLUSIONS
In summary, the lack of studies reporting poorer outcomes with them compared to conventional practices, and a cumulative effect direction in their favour, provide strong indications in support of the use of AlloDerm™, Integra™, or Matriderm™ grafts. Further comparative studies, including RCTs, are needed to reinforce these initial indications.
Topics: Adult; Humans; Esthetics; Free Tissue Flaps; Plastic Surgery Procedures; Retrospective Studies; Skin Transplantation
PubMed: 38101265
DOI: 10.1016/j.bjps.2023.11.046 -
Journal of Comparative Effectiveness... Sep 2020Venous leg ulcers (VLUs) present a significant economic burden on the US healthcare system and payers (US$14.9 billion). To evaluate the quality of life (QoL) of...
Venous leg ulcers (VLUs) present a significant economic burden on the US healthcare system and payers (US$14.9 billion). To evaluate the quality of life (QoL) of patients with VLUs; to analyze the limitations of standard of care (SOC) for VLUs; and to explain how using bilayered living cellular construct (BLCC) with SOC for treatment of VLUs can help heal more VLUs faster (than using SOC alone) as well as help improve QoL and help reduce the burden on the US healthcare system and payers. This is a review study. The search was conducted in February 2020 by way of electronic databases to find relevant articles that provided information related to QoL of patients with VLUs, limitations of SOC for VLUs and economic analyses of using BLCC for treatment of VLUs. VLUs impact patients' physical, functional and psychological status and reduce QoL. A total 75% of VLU patients who used SOC alone failed to achieve healing in a timely fashion, which led to increased healthcare costs and healthcare resource utilization. Although the upfront cost is high, the greater effectiveness of BLCC offsets the added cost of the product during the time period of the studies. Therefore, BLCC helps to improve the QoL of VLU patients. As an example, for every 100 VLU patients in a healthcare plan, the use of BLCC can create cost savings of US$1,349,829.51. Payers' coverage of BLCC results in reduction of the overall medical cost for treating VLU patients.
Topics: Cost-Benefit Analysis; Health Care Costs; Humans; Leg Ulcer; Quality of Life; Skin, Artificial; Varicose Ulcer; Wound Healing
PubMed: 32969709
DOI: 10.2217/cer-2020-0076 -
The Cochrane Database of Systematic... May 2020Chronic plaque psoriasis is an immune-mediated, chronic, inflammatory skin disease, which can impair quality of life and social interaction. Disease severity can be... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Chronic plaque psoriasis is an immune-mediated, chronic, inflammatory skin disease, which can impair quality of life and social interaction. Disease severity can be classified by the psoriasis area and severity index (PASI) score ranging from 0 to 72 points. Indoor artificial salt bath with or without artificial ultraviolet B (UVB) light is used to treat psoriasis, simulating sea bathing and sunlight exposure; however, the evidence base needs clear evaluation.
OBJECTIVES
To assess the effects of indoor (artificial) salt water baths followed by exposure to artificial UVB for treating chronic plaque psoriasis in adults.
SEARCH METHODS
We searched the following databases up to June 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trial registers, and checked the reference lists of included studies, recent reviews, and relevant papers for further references to relevant trials.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of salt bath indoors followed by exposure to artificial UVB in adults who have been diagnosed with chronic plaque type psoriasis. We included studies reporting between-participant data and within-participant data. We evaluated two different comparisons: 1) salt bath + UVB versus other treatment without UVB; eligible comparators were exposure to psoralen bath, psoralen bath + artificial ultraviolet A UVA) light, topical treatment, systemic treatment, or placebo, and 2) salt bath + UVB versus other treatment + UVB or UVB only; eligible comparators were exposure to bath containing other compositions or concentrations + UVB or UVB only.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence. The primary efficacy outcome was PASI-75, to detect people with a 75% or more reduction in PASI score from baseline. The primary adverse outcome was treatment-related adverse events requiring withdrawal. For the dichotomous variables PASI-75 and treatment-related adverse events requiring withdrawal, we estimated the proportion of events among the assessed participants. The secondary outcomes were health-related quality of life using the Dermatology Life Quality Index, (DLQI) pruritus severity measured using a visual analogue scale, time to relapse, and secondary malignancies.
MAIN RESULTS
We included eight RCTs: six reported between-participant data (2035 participants; 1908 analysed), and two reported within-participant data (70 participants, 68 analysed; 140 limbs; 136 analysed). One study reported data for the comparison salt bath with UVB versus other treatment without UVB; and eight studies reported data for salt bath with UVB versus other treatment with UVB or UVB only. Of these eight studies, only five reported any of our pre-specified outcomes and assessed the comparison of salt bath with UVB versus UVB only. The one included trial that assessed salt bath plus UVB versus other treatment without UVB (psoralen bath + UVA) did not report any of our primary outcomes. The mean age of the participants ranged from 41 to 50 years of age in 75% of the studies. None of the included studies reported on the predefined secondary outcomes of this review. We judged seven of the eight studies as at high risk of bias in at least one domain, most commonly performance bias. Total trial duration ranged between at least two months and up to 13 months. In five studies, the median participant PASI score at baseline ranged from 15 to 18 and was balanced between treatment arms. Three studies did not report PASI score. Most studies were conducted in Germany; all were set in Europe. Half of the studies were multi-centred (set in spa centres or outpatient clinics); half were set in a single centre in either an unspecified settings, a psoriasis daycare centre, or a spa centre. Commercial spa or salt companies sponsored three of eight studies, health insurance companies funded another, the association of dermatologists funded another, and three did not report on funding. When comparing salt bath plus UVB versus UVB only, two between-participant studies found that salt bath plus UVB may improve psoriasis when measured using PASI 75 (achieving a 75% or more reduction in PASI score from baseline) (risk ratio (RR) 1.71, 95% confidence interval (CI) 1.24 to 2.35; 278 participants; low-certainty evidence). Assessment was conducted at the end of treatment, which was equivalent to six to eight weeks after start of treatment. The two trials which contributed data for the primary efficacy outcome were conducted by the same group, and did not blind outcome assessors. The German Spas Association funded one of the trials and the funding source was not stated for the other trial. Two other between-participant studies found salt bath plus UVB may make little to no difference to outcome treatment-related adverse events requiring withdrawal compared with UVB only (RR 0.96, 95% CI 0.35 to 2.64; 404 participants; low-certainty evidence). One of the studies reported adverse events, but did not specify the type of events; the other study reported skin irritation. One within-participant study found similar results, with one participant reporting severe itch immediately after Dead Sea salt soak in the salt bath and UVB group and two instances of inadequate response to phototherapy and conversion to psoralen bath + UVA reported in the UVB only group (low-certainty evidence).
AUTHORS' CONCLUSIONS
Salt bath with artificial ultraviolet B (UVB) light may improve psoriasis in people with chronic plaque psoriasis compared with UVB light treatment alone, and there may be no difference in the occurrence of treatment-related adverse events requiring withdrawal. Both results are based on data from a limited number of studies, which provided low-certainty evidence, so we cannot draw any clear conclusions. The reporting of our pre-specified outcomes was either non-existent or limited, with a maximum of two studies reporting a given outcome. The same group conducted the two trials which contributed data for the primary efficacy outcome, and the German Spas Association funded one of these trials. We recommend further RCTs that assess PASI-75, with detailed reporting of the outcome and time point, as well as treatment-related adverse events. Risk of bias was an issue; future studies should ensure blinding of outcome assessors and full reporting.
Topics: Adult; Baths; Chronic Disease; Combined Modality Therapy; Female; Ficusin; Humans; Male; Middle Aged; Mineral Waters; PUVA Therapy; Photosensitizing Agents; Psoriasis; Randomized Controlled Trials as Topic; Sodium Chloride; Ultraviolet Therapy
PubMed: 32368795
DOI: 10.1002/14651858.CD011941.pub2 -
PloS One 2021To compare the safety and effectiveness between helmet and face mask noninvasive mechanical ventilation (NIMV) in patients with acute respiratory failure (ARF). (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To compare the safety and effectiveness between helmet and face mask noninvasive mechanical ventilation (NIMV) in patients with acute respiratory failure (ARF).
METHODS
English databases included PubMed, EMBASE, Cochrane Central Register of Controlled Trials and Web of Science. Chinese databases involved Wanfang Data, China Knowledge Resource Integrated Database and Chinese Biological Medicine Database. Randomized controlled trials (RCTs) comparing helmet and face mask NIMV for patients with ARF were searched. Meta-analysis was performed using Review manager 5.1.0.
RESULTS
Twelve trials with a total of 569 patients were eligible. Our meta-analysis showed that, comparing with face mask, helmet could significantly decrease the incidences of intolerance [risk ratio (RR) 0.19; 95% confidence interval (CI) 0.09-0.39], facial skin ulcer (RR 0.19; 95% CI 0.08-0.43) and aerophagia (RR 0.15; 95% CI 0.06-0.37), reduce respiratory rate [mean difference (MD) -3.10; 95% CI -4.85 to -1.34], intubation rate (RR 0.39; 95% CI 0.26-0.59) and hospital mortality (RR 0.62; 95% CI 0.39-0.99) in patients with ARF, and improve oxygenation index in patients with hypoxemic ARF (MD 55.23; 95% CI 31.37-79.09). However, subgroupanalysis for hypercapnic ARF revealed that PaCO2 was significantly reduced in face mask group compared with helmet group (MD 5.34; 95% CI 3.41-7.27).
CONCLUSION
NIMV with helmet can improve the patient's tolerance, reduce adverse events, increase oxygenation effect, and decrease intubation rate and hospital mortality comparing to face mask. However, the low number of patients from included studies may preclude strong conclusions. Large RCTs are still needed to provide more robust evidence.
Topics: Acute Disease; Head Protective Devices; Humans; Noninvasive Ventilation; Respiration, Artificial; Respiratory Insufficiency
PubMed: 33857228
DOI: 10.1371/journal.pone.0250063 -
Dermatology and Therapy Mar 2022Notwithstanding their numerous advantages, biological treatments have many limitations when treating patients with psoriasis (PsO) and hepatitis B (HB). Clinicians need...
INTRODUCTION
Notwithstanding their numerous advantages, biological treatments have many limitations when treating patients with psoriasis (PsO) and hepatitis B (HB). Clinicians need to pay careful attention to the issue of hepatitis B virus (HBV) reactivation.
METHODS
In accordance with the PRISMA guidelines, we systematically searched Pubmed, Scopus, Embase, Cochrane Library, and Web of Science databases for observational studies on the topic of HBV reactivation among patients with PsO and HB treated with biologics. The random-effects model was used to pool the reactivation rate by the Freeman-Tukey double arcsine transformation method. We selected Fisher's exact test to compare multiple rates. To determine the sources of heterogeneity, sensitivity analysis and meta-regression were performed.
RESULTS
Ten studies with a total of 238 subjects that met the inclusion criteria were included. The pooled reactivation rate was 1.8% [95% confidence interval (CI) 0.0-5.6%] in patients with PsO and HB. Among them, the viral reactivation rates of HBsAg-positive and HBsAg-negative patients were 4.1% (95% CI 0.0-17.9%) and 0.2% (95% CI 0.0-2.8%). The difference between HBsAg-positive and HBsAg-negative patients was statistically significant (p = 0.002). The viral reactivation rate of individuals who needed antiviral prophylaxis but did not receive it was 26.6% (95% CI 5.8-53.5%), while it decreased to 0.0% (95% CI 0.0-6.6%) after accepting antiviral treatment. The two-sided Fisher's test exact values between different durations of biological therapy showed no statistical significance (p = 0.104).
CONCLUSIONS
Without antiviral prophylaxis, HBsAg-positive patients with psoriasis are at high risk of virus reactivation when treated with biological agents. Early and sufficient antiviral prophylaxis will effectively reduce the risk of HBV reactivation and serious complications in HBsAg-positive patients. Prolonging the duration of biological treatment will not increase the risk of reactivation.
PubMed: 35094295
DOI: 10.1007/s13555-022-00682-5