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The Cochrane Database of Systematic... 2000This section is under preparation and will be included in the next issue. (Review)
Review
BACKGROUND
This section is under preparation and will be included in the next issue.
OBJECTIVES
To determine whether the material used for construction of an umbilical arterial catheter influences the frequency of ischemic events, aortic thrombosis, mortality or necrotising enterocolitis in newborn infants.
SEARCH STRATEGY
Randomized and quasi randomized controlled trials of umbilical catheterization use were obtained from the following sources: 1. Effective Care of the Newborn Infant, edited by JC Sinclair and MB Bracken. 2. Medline Search using Melvyl Medline Plus and the keyword headings "Umbilic#", "Catheter#" and subject heading "Infant, Newborn" 3. Search of personal data files
SELECTION CRITERIA
Randomized studies in newborn infants of any birthweight or gestation. Comparison of different catheter materials. Clinically important end points such as ischemic events, aortic thrombosis, or catheter occlusion.
DATA COLLECTION AND ANALYSIS
One non-randomized and one randomized study were retrieved.
MAIN RESULTS
There were no significant effects of substituting a heparin bonded polyurethane catheter for the standard PVC catheter. The non-randomized study suggested that there may possibly be a benefit of using a catheter constructed from Silastic, with a reduction in aortic thrombosis.
REVIEWER'S CONCLUSIONS
There are no demonstrated clinically relevant differences in outcomes between the use of PVC catheters and other materials. Therefore, other considerations such as price and ease of availability may dictate the catheter chosen. An adequately powered randomized comparison of silastic to PVC should be performed.
Topics: Catheterization; Humans; Infant, Newborn; Umbilical Arteries
PubMed: 10796392
DOI: 10.1002/14651858.CD000949 -
Contraception Nov 2003This systematic review sought to evaluate nonlatex male condoms in comparison with latex condoms in terms of contraceptive efficacy, breakage, slippage, safety and user... (Comparative Study)
Comparative Study Review
This systematic review sought to evaluate nonlatex male condoms in comparison with latex condoms in terms of contraceptive efficacy, breakage, slippage, safety and user preferences. We searched computerized databases and contacted manufactures and investigators to find randomized controlled trials of nonlatex vs. latex male condoms. Two reviewers independently abstracted data from the 10 identified trials. While the eZ. on condom did not protect against pregnancy as well as its latex comparison condom, no differences were found in typical-use efficacy between the Avanti and the Standard Tactylon and their latex counterparts. Nonlatex condoms were associated with higher rates of clinical breakage than their latex comparisons, with statistically significant odds ratios of clinical breakage ranging from 2.6 (95% confidence interval [CI]: 1.6-4.3) to 5.0 (95% CI: 3.6-6.8). Few adverse events were reported. Substantial proportions of participants reported preferences for the nonlatex condoms. Despite higher rates of clinical breakage, nonlatex condoms still provide an acceptable alternative for those with allergies, sensitivities or preferences that might prevent the consistent use of latex condoms. The contraceptive efficacy of nonlatex condoms requires more research.
Topics: Condoms; Contraception; Equipment Failure; Humans; Latex; Male; Polyurethanes; Randomized Controlled Trials as Topic
PubMed: 14636934
DOI: 10.1016/j.contraception.2003.08.015 -
Anesthesia and Analgesia Apr 2009In this systematic review, we evaluated the evidence for seven strategies which have been proposed to minimize the incidence of epidural vein cannulation during lumbar... (Review)
Review
BACKGROUND
In this systematic review, we evaluated the evidence for seven strategies which have been proposed to minimize the incidence of epidural vein cannulation during lumbar epidural catheter placement in pregnant women.
METHODS
Multiple databases were searched to identify prospective, randomized, controlled trials between December 1966 and October 2007 that evaluated methods to avoid epidural vein cannulation after lumbar epidural catheter placement in pregnant women. Published trials were evaluated using a quality assessment tool, and results were combined to evaluate efficacy to prevent epidural vein cannulation.
RESULTS
Of 90 trials screened, 30 trials were included (n = 12,738 subjects). Five strategies reduce the risk of epidural vein cannulation: the lateral as opposed to sitting position (six trials, mean (sd) quality score = 35% [11%], odds ratio (OR) 0.53 [95% confidence interval (CI) 0.32-0.86]), fluid administered through the epidural needle before catheter insertion (8 trials, quality score 48% [18%], OR 0.49 [95% CI 0.25-0.97]), single rather than multiorifice catheter (5 trials, quality score 30% [6%], OR 0.64 [95% CI 0.45-0.91]), a wire-embedded polyurethane compared with polyamide epidural catheter (1 trial, 31%, plus 4 unscored abstracts, OR 0.14 [95% CI 0.06-0.30]) and catheter insertion depth < or =6 cm (2 trials, 47% [11%], OR 0.27 [95% CI 0.10-0.74]). The paramedian as opposed to midline needle approach and smaller epidural needle or catheter gauges do not reduce the risk of epidural vein cannulation.
CONCLUSION
The risk of intravascular placement of a lumbar epidural catheter in pregnancy may be reduced with the lateral patient position, fluid predistension, a single orifice catheter, a wire-embedded polyurethane epidural catheter and limiting the depth of catheter insertion to 6 cm or less. In general, low manuscript quality weakens the strength of these conclusions.
Topics: Analgesia, Epidural; Analgesia, Obstetrical; Anesthesia, Epidural; Anesthesia, Obstetrical; Catheterization; Catheters, Indwelling; Epidural Space; Equipment Design; Female; Humans; Lumbar Vertebrae; Medication Errors; Needles; Odds Ratio; Polyurethanes; Posture; Pregnancy; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Veins
PubMed: 19299793
DOI: 10.1213/ane.0b013e318198f85e -
The Cochrane Database of Systematic... Feb 2021Extracranial carotid artery stenosis is the major cause of stroke, which can lead to disability and mortality. Carotid endarterectomy (CEA) with carotid patch... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Extracranial carotid artery stenosis is the major cause of stroke, which can lead to disability and mortality. Carotid endarterectomy (CEA) with carotid patch angioplasty is the most popular technique for reducing the risk of stroke. Patch material may be made from an autologous vein, bovine pericardium, or synthetic material including polytetrafluoroethylene (PTFE), Dacron, polyurethane, and polyester. This is an update of a review that was first published in 1996 and was last updated in 2010.
OBJECTIVES
To assess the safety and efficacy of different types of patch materials used in carotid patch angioplasty. The primary hypothesis was that a synthetic material was associated with lower risk of patch rupture versus venous patches, but that venous patches were associated with lower risk of perioperative stroke and early or late infection, or both.
SEARCH METHODS
We searched the Cochrane Stroke Group trials register (last searched 25 May 2020); the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 4), in the Cochrane Library; MEDLINE (1966 to 25 May 2020); Embase (1980 to 25 May 2020); the Index to Scientific and Technical Proceedings (1980 to 2019); the Web of Science Core Collection; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) portal. We handsearched relevant journals and conference proceedings, checked reference lists, and contacted experts in the field.
SELECTION CRITERIA
Randomised and quasi-randomised trials (RCTs) comparing one type of carotid patch with another for CEA.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed eligibility, risk of bias, and trial quality; extracted data; and determined the quality of evidence using the GRADE approach. Outcomes, for example, perioperative ipsilateral stroke and long-term ipsilateral stroke (at least one year), were collected and analysed.
MAIN RESULTS
We included 14 trials involving a total of 2278 CEAs with patch closure operations: seven trials compared vein closure with PTFE closure, five compared Dacron grafts with other synthetic materials, and two compared bovine pericardium with other synthetic materials. In most trials, a patient could be randomised twice and could have each carotid artery randomised to different treatment groups. Synthetic patch compared with vein patch angioplasty Vein patch may have little to no difference in effect on perioperative ipsilateral stroke between synthetic versus vein materials, but the evidence is very uncertain (odds ratio (OR) 2.05, 95% confidence interval (CI) 0.66 to 6.38; 5 studies, 797 participants; very low-quality evidence). Vein patch may have little to no difference in effect on long-term ipsilateral stroke between synthetic versus vein materials, but the evidence is very uncertain (OR 1.45, 95% CI 0.69 to 3.07; P = 0.33; 4 studies, 776 participants; very low-quality evidence). Vein patch may increase pseudoaneurysm formation when compared with synthetic patch, but the evidence is very uncertain (OR 0.09, 95% CI 0.02 to 0.49; 4 studies, 776 participants; very low-quality evidence). However, the numbers involved were small. Dacron patch compared with other synthetic patch angioplasty Dacron versus PTFE patch materials PTFE patch may reduce the risk of perioperative ipsilateral stroke (OR 3.35, 95% CI 0.19 to 59.06; 2 studies, 400 participants; very low-quality evidence). PTFE patch may reduce the risk of long-term ipsilateral stroke (OR 1.52, 95% CI 0.25 to 9.27; 1 study, 200 participants; very low-quality evidence). Dacron may result in an increase in perioperative combined stroke and transient ischaemic attack (TIA) (OR 4.41 95% CI 1.20 to 16.14; 1 study, 200 participants; low-quality evidence) when compared with PTFE. Early arterial re-stenosis or occlusion (within 30 days) was also higher for Dacron patches. During follow-up for longer than one year, more 'any strokes' (OR 10.58, 95% CI 1.34 to 83.43; 2 studies, 304 participants; low-quality evidence) and stroke/death (OR 6.06, 95% CI 1.31 to 28.07; 1 study, 200 participants; low-quality evidence) were reported with Dacron patch closure, although numbers of outcome events were small. Dacron patch may increase the risk of re-stenosis when compared with other synthetic materials (especially with PTFE), but the evidence is very uncertain (OR 3.73, 95% CI 0.71 to 19.65; 3 studies, 490 participants; low-quality evidence). Bovine pericardium patch compared with other synthetic patch angioplasty Bovine pericardium versus PTFE patch materials Evidence suggests that bovine pericardium patch results in a reduction in long-term ipsilateral stroke (OR 4.17, 95% CI 0.46 to 38.02; 1 study, 195 participants; low-quality evidence). Bovine pericardial patch may reduce the risk of perioperative fatal stroke, death, and infection compared to synthetic material (OR 5.16, 95% CI 0.24 to 108.83; 2 studies, 290 participants; low-quality evidence for PTFE, and low-quality evidence for Dacron; OR 4.39, 95% CI 0.48 to 39.95; 2 studies, 290 participants; low-quality evidence for PTFE, and low-quality evidence for Dacron; OR 7.30, 95% CI 0.37 to 143.16; 1 study, 195 participants; low-quality evidence, respectively), but the numbers of outcomes were small. The evidence is very uncertain about effects of the patch on infection outcomes.
AUTHORS' CONCLUSIONS
The number of outcome events is too small to allow conclusions, and more trial data are required to establish whether any differences do exist. Nevertheless, there is little to no difference in effect on perioperative and long-term ipsilateral stroke between vein and any synthetic patch material. Some evidence indicates that other synthetic patches (e.g. PTFE) may be superior to Dacron grafts in terms of perioperative stroke and TIA rates, and both early and late arterial re-stenosis and occlusion. Pseudoaneurysm formation may be more common after use of a vein patch than after use of a synthetic patch. Bovine pericardial patch, which is an acellular xenograft material, may reduce the risk of perioperative fatal stroke, death, and infection compared to other synthetic patches. Further large RCTs are required before definitive conclusions can be reached.
Topics: Aneurysm, False; Angioplasty; Bias; Bioprosthesis; Blood Vessel Prosthesis; Carotid Stenosis; Endarterectomy, Carotid; Humans; Polyethylene Terephthalates; Polytetrafluoroethylene; Postoperative Complications; Randomized Controlled Trials as Topic; Saphenous Vein; Stroke
PubMed: 33598915
DOI: 10.1002/14651858.CD000071.pub4 -
The Cochrane Database of Systematic... May 2022Sacrococcygeal pilonidal sinus disease is a common debilitating condition that predominantly affects young adults, with a profound impact on their activities of daily... (Review)
Review
BACKGROUND
Sacrococcygeal pilonidal sinus disease is a common debilitating condition that predominantly affects young adults, with a profound impact on their activities of daily living. The condition is treated surgically, and in some cases the wound in the natal cleft is left open to heal by itself. Many dressings and topical agents are available to aid healing of these wounds.
OBJECTIVES
To assess the effects of dressings and topical agents for the management of open wounds following surgical treatment for sacrococcygeal pilonidal sinus in any care setting.
SEARCH METHODS
In March 2021, we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and we scanned reference lists of included studies, 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 parallel-group randomised controlled trials (RCTs) only. We included studies with participants who had undergone any type of sacrococcygeal pilonidal sinus disease surgery and were left with an open wound.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence for each outcome.
MAIN RESULTS
We included 11 RCTs comprising 932 participants. Two studies compared topical negative pressure wound therapy (TNPWT) with conventional open wound healing, two studies compared platelet-rich plasma with sterile absorbent gauze, and the other seven studies compared various dressings and topical agents. All studies were at high risk of bias in at least one domain, whilst one study was judged to be at low risk of bias in all but one domain. All studies were conducted in secondary care. Mean participant ages were between 20 and 30 years, and nearly 80% of participants were male. No studies provided data on quality of life, cost-effectiveness, pain at first dressing change or proportion of wounds healed at 6 or 12 months, and very few adverse effects were recorded in any study. It is unclear whether TNPWT reduces time to wound healing compared with conventional open wound healing (comparison 1), as the certainty of evidence is very low. The two studies provided conflicting results, with one study showing benefit (mean difference (MD) -24.01 days, 95% confidence interval (CI) -35.65 to -12.37; 19 participants), whilst the other reported no difference. It is also unclear whether TNPWT has any effect on the proportion of wounds healed by 30 days (risk ratio (RR) 3.60, 95% CI 0.49 to 26.54; 19 participants, 1 study; very low-certainty evidence). Limited data were available for our secondary outcomes time to return to normal daily activities and recurrence rate; we do not know whether TNPWT has any effect on these outcomes. Lietofix cream may increase the proportion of wounds that heal by 30 days compared with an iodine dressing (comparison 4; RR 8.06, 95% CI 1.05 to 61.68; 205 participants, 1 study; low-certainty evidence). The study did not provide data on time to wound healing. We do not know whether hydrogel dressings reduce time to wound healing compared with wound cleaning with 10% povidone iodine (comparison 5; MD -24.54 days, 95% CI -47.72 to -1.36; 31 participants, 1 study; very low-certainty evidence). The study did not provide data on the proportion of wounds healed. It is unclear whether hydrogel dressings have any effect on adverse effects as the certainty of the evidence is very low. Platelet-rich plasma may reduce time to wound healing compared with sterile absorbent gauze (comparison 6; MD -19.63 days, 95% CI -34.69 to -4.57; 210 participants, 2 studies; low-certainty evidence). No studies provided data on the proportion of wounds healed. Platelet-rich plasma may reduce time to return to normal daily activities (MD -15.49, 95% CI -28.95 to -2.02; 210 participants, 2 studies; low-certainty evidence). Zinc oxide mesh may make little or no difference to time to wound healing compared with placebo (comparison 2; median 54 days in the zinc oxide mesh group versus 62 days in the placebo mesh group; low-certainty evidence). We do not know whether zinc oxide mesh has an effect on the proportion of wounds healed by 30 days as the certainty of the evidence is very low (RR 2.35, 95% CI 0.49 to 11.23). It is unclear whether gentamicin-impregnated collagen sponge reduces time to wound healing compared with no dressing (comparison 7; MD -1.40 days, 95% CI -5.05 to 2.25; 50 participants, 1 study; very low-certainty evidence). The study did not provide data on the proportion of wounds healed. Dialkylcarbamoyl chloride (DACC)-coated dressings may make little or no difference to time to wound healing compared with alginate dressings (comparison 8; median 69 (95% CI 62 to 72) days in the DACC group versus 71 (95% CI 69 to 85) days in the alginate group; 1 study, 246 participants; low-certainty evidence). One study compared a polyurethane foam hydrophilic dressing with an alginate dressing (comparison 3) whilst another study compared a hydrocolloid dressing with an iodine dressing (comparison 9). It is unclear whether either intervention has any effect on time to wound healing as the certainty of evidence is very low.
AUTHORS' CONCLUSIONS
At present, the evidence that any of the dressings or topical agents contained in this review have a benefit on time to wound healing, the proportion of wounds that heal at a specific time point or on any of the secondary outcomes of our review ranges from low certainty to very low certainty. There is low-certainty evidence on the benefit on wound healing of platelet-rich plasma from two studies and of Lietofix cream and hydrogel dressings from single studies. Further studies are required to investigate these interventions further.
Topics: Adult; Alginates; Bandages; Female; Humans; Hydrogels; Iodine; Male; Pilonidal Sinus; Young Adult; Zinc Oxide
PubMed: 35593897
DOI: 10.1002/14651858.CD013439.pub2 -
The Cochrane Database of Systematic... Mar 2016Central venous catheters (CVCs) provide secured venous access in neonates. Antimicrobial dressings applied over the CVC sites have been proposed to reduce... (Review)
Review
BACKGROUND
Central venous catheters (CVCs) provide secured venous access in neonates. Antimicrobial dressings applied over the CVC sites have been proposed to reduce catheter-related blood stream infection (CRBSI) by decreasing colonisation. However, there may be concerns on the local and systemic adverse effects of these dressings in neonates.
OBJECTIVES
We assessed the effectiveness and safety of antimicrobial (antiseptic or antibiotic) dressings in reducing CVC-related infections in newborn infants. Had there been relevant data, we would have evaluated the effects of antimicrobial dressings in different subgroups, including infants who received different types of CVCs, infants who required CVC for different durations, infants with CVCs with and without other antimicrobial modifications, and infants who received an antimicrobial dressing with and without a clearly defined co-intervention.
SEARCH METHODS
We used the standard search strategy of the Cochrane Neonatal Review Group (CNRG). We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2015, Issue 9), MEDLINE (PubMed), EMBASE (EBCHOST), CINAHL and references cited in our short-listed articles using keywords and MeSH headings, up to September 2015.
SELECTION CRITERIA
We included randomised controlled trials that compared an antimicrobial CVC dressing against no dressing or another dressing in newborn infants.
DATA COLLECTION AND ANALYSIS
We extracted data using the standard methods of the CNRG. Two review authors independently assessed the eligibility and risk of bias of the retrieved records. We expressed our results using risk difference (RD) and risk ratio (RR) with 95% confidence intervals (CIs).
MAIN RESULTS
Out of 173 articles screened, three studies were included. There were two comparisons: chlorhexidine dressing following alcohol cleansing versus polyurethane dressing following povidone-iodine cleansing (one study); and silver-alginate patch versus control (two studies). A total of 855 infants from level III neonatal intensive care units (NICUs) were evaluated, 705 of whom were from a single study. All studies were at high risk of bias for blinding of care personnel or unclear risk of bias for blinding of outcome assessors. There was moderate-quality evidence for all major outcomes.The single study comparing chlorhexidine dressing/alcohol cleansing against polyurethane dressing/povidone-iodine cleansing showed no significant difference in the risk of CRBSI (RR 1.18, 95% CI 0.53 to 2.65; RD 0.01, 95% CI -0.02 to 0.03; 655 infants, moderate-quality evidence) and sepsis without a source (RR 1.06, 95% CI 0.75 to 1.52; RD 0.01, 95% CI -0.04 to 0.06; 705 infants, moderate-quality evidence). There was a significant reduction in the risk of catheter colonisation favouring chlorhexidine dressing/alcohol cleansing group (RR 0.62, 95% CI 0.45 to 0.86; RD -0.09, 95% CI -0.15 to -0.03; number needed to treat for an additional beneficial outcome (NNTB) 11, 95% CI 7 to 33; 655 infants, moderate-quality evidence). However, infants in the chlorhexidine dressing/alcohol cleansing group were significantly more likely to develop contact dermatitis, with 19 infants in the chlorhexidine dressing/alcohol cleansing group having developed contact dermatitis compared to none in the polyurethane dressing/povidone-iodine cleansing group (RR 43.06, 95% CI 2.61 to 710.44; RD 0.06, 95% CI 0.03 to 0.08; number needed to treat for an additional harmful outcome (NNTH) 17, 95% CI 13 to 33; 705 infants, moderate-quality evidence). The roles of chlorhexidine dressing in the outcomes reported were unclear, as the two assigned groups received different co-interventions in the form of different skin cleansing agents prior to catheter insertion and during each dressing change.In the other comparison, silver-alginate patch versus control, the data for CRBSI were analysed separately in two subgroups as the two included studies reported the outcome using different denominators: one using infants and another using catheters. There were no significant differences between infants who received silver-alginate patch against infants who received standard line dressing in CRBSI, whether expressed as the number of infants (RR 0.50, 95% CI 0.14 to 1.78; RD -0.12, 95% CI -0.33 to 0.09; 1 study, 50 participants, moderate-quality evidence) or as the number of catheters (RR 0.72, 95% CI 0.27 to 1.89; RD -0.05, 95% CI -0.20 to 0.10; 1 study, 118 participants, moderate-quality evidence). There was also no significant difference between the two groups in mortality (RR 0.55, 95% CI 0.15 to 2.05; RD -0.04, 95% CI -0.13 to 0.05; two studies, 150 infants, I² = 0%, moderate-quality evidence). No adverse skin reaction was recorded in either group.
AUTHORS' CONCLUSIONS
Based on moderate-quality evidence, chlorhexidine dressing/alcohol skin cleansing reduced catheter colonisation, but made no significant difference in major outcomes like sepsis and CRBSI compared to polyurethane dressing/povidone-iodine cleansing. Chlorhexidine dressing/alcohol cleansing posed a substantial risk of contact dermatitis in preterm infants, although it was unclear whether this was contributed mainly by the dressing material or the cleansing agent. While silver-alginate patch appeared safe, evidence is still insufficient for a recommendation in practice. Future research that evaluates antimicrobial dressing should ensure blinding of caregivers and outcome assessors and ensure that all participants receive the same co-interventions, such as the skin cleansing agent. Major outcomes like sepsis, CRBSI and mortality should be assessed in infants of different gestation and birth weight.
Topics: Alginates; Anti-Bacterial Agents; Anti-Infective Agents; Bandages; Catheter-Related Infections; Catheterization, Central Venous; Central Venous Catheters; Chlorhexidine; Dermatitis, Contact; Ethanol; Glucuronic Acid; Hexuronic Acids; Humans; Infant, Newborn; Polyurethanes; Povidone-Iodine; Randomized Controlled Trials as Topic; Silver Compounds
PubMed: 27007217
DOI: 10.1002/14651858.CD011082.pub2 -
The Cochrane Database of Systematic... Jan 2020It is estimated that up to 1% of people in high-income countries suffer from a leg ulcer at some time in their life. The majority of leg ulcers are associated with... (Meta-Analysis)
Meta-Analysis
BACKGROUND
It is estimated that up to 1% of people in high-income countries suffer from a leg ulcer at some time in their life. The majority of leg ulcers are associated with circulation problems; poor blood return in the veins causes venous ulcers (around 70% of ulcers) and poor blood supply to the legs causes arterial ulcers (around 22% of ulcers). Treatment of arterial leg ulcers is directed towards correcting poor arterial blood supply, for example by correcting arterial blockages (either surgically or pharmaceutically). If the blood supply has been restored, these arterial ulcers can heal following principles of good wound-care. Dressings and topical agents make up a part of good wound-care for arterial ulcers, but there are many products available, and it is unclear what impact these have on ulcer healing. This is the third update of a review first published in 2003.
OBJECTIVES
To determine whether topical agents and wound dressings affect healing in arterial ulcers. To compare healing rates and patient-centred outcomes between wound dressings and topical agents.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature and Allied and Complementary Medicine databases, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 28 January 2019.
SELECTION CRITERIA
Randomised controlled trials (RCTs), or controlled clinical trials (CCTs) evaluating dressings and topical agents in the treatment of arterial leg ulcers were eligible for inclusion. We included participants with arterial leg ulcers irrespective of method of diagnosis. Trials that included participants with mixed arterio-venous disease and diabetes were eligible for inclusion if they presented results separately for the different groups. All wound dressings and topical agents were eligible for inclusion in this review. We excluded trials which did not report on at least one of the primary outcomes (time to healing, proportion completely healed, or change in ulcer area).
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted information on the participants' characteristics, the interventions, and outcomes using a standardised data extraction form. Review authors resolved any disagreements through discussion. We presented the data narratively due to differences in the included trials. We used GRADE to assess the certainty of the evidence.
MAIN RESULTS
Two trials met the inclusion criteria. One compared 2% ketanserin ointment in polyethylene glycol (PEG) with PEG alone, used twice a day by 40 participants with arterial leg ulcers, for eight weeks or until healing, whichever was sooner. One compared topical application of blood-derived concentrated growth factor (CGF) with standard dressing (polyurethane film or foam); both applied weekly for six weeks by 61 participants with non-healing ulcers (venous, diabetic arterial, neuropathic, traumatic, or vasculitic). Both trials were small, reported results inadequately, and were of low methodological quality. Short follow-up times (six and eight weeks) meant it would be difficult to capture sufficient healing events to allow us to make comparisons between treatments. One trial demonstrated accelerated wound healing in the ketanserin group compared with the control group. In the trial that compared CGF with standard dressings, the number of participants with diabetic arterial ulcers were only reported in the CGF group (9/31), and the number of participants with diabetic arterial ulcers and their data were not reported separately for the standard dressing group. In the CGF group, 66.6% (6/9) of diabetic arterial ulcers showed more than a 50% decrease in ulcer size compared to 6.7% (2/30) of non-healing ulcers treated with standard dressing. We assessed this as very-low certainty evidence due to the small number of studies and arterial ulcer participants, inadequate reporting of methodology and data, and short follow-up period. Only one trial reported side effects (complications), stating that no participant experienced these during follow-up (six weeks, low-certainty evidence). It should also be noted that ketanserin is not licensed in all countries for use in humans. Neither study reported time to ulcer healing, patient satisfaction or quality of life.
AUTHORS' CONCLUSIONS
There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers.
Topics: Administration, Topical; Arteries; Bandages, Hydrocolloid; Humans; Leg Ulcer; Occlusive Dressings; Ointments; Randomized Controlled Trials as Topic; Varicose Ulcer; Wound Healing
PubMed: 31978262
DOI: 10.1002/14651858.CD001836.pub4 -
The Cochrane Database of Systematic... May 2024Peripheral arterial catheters (ACs) are used in anaesthesia and intensive care settings for blood sampling and monitoring. Despite their importance, ACs often fail,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Peripheral arterial catheters (ACs) are used in anaesthesia and intensive care settings for blood sampling and monitoring. Despite their importance, ACs often fail, requiring reinsertion. Dressings and securement devices maintain AC function and prevent complications such as infection.
OBJECTIVES
To evaluate the effectiveness of peripheral AC dressing and securement devices to prevent failure and complications in hospitalised people.
SEARCH METHODS
We searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL Plus up to 16 May 2023. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform up to 16 May 2023.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing different dressing and securement devices for the stabilisation of ACs in hospitalised people.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials for inclusion, extracted data, and assessed risk of bias using Cochrane's RoB 1 tool. We resolved disagreements by discussion, or by consulting a third review author when necessary. We assessed the certainty of evidence using GRADE.
MAIN RESULTS
We included five RCTs with 1228 participants and 1228 ACs. All included studies had high risk of bias in one or more domains. We present the following four comparisons, with the remaining comparisons reported in the main review. Standard polyurethane (SPU) plus tissue adhesive (TA) compared with SPU: we are very uncertain whether use of SPU plus TA impacts rates of AC failure (risk ratio (RR) 0.44, 95% confidence interval (CI) 0.20 to 0.98; I² = 0%; 2 studies, 165 participants; very low-certainty evidence). Neither study (165 participants) reported catheter-related bloodstream infections (CRBSI), thus we are very uncertain whether SPU plus TA impacts on the incidence of CRBSI (very low-certainty evidence). It is very uncertain whether use of SPU plus TA impacts AC dislodgement risk (RR 0.54, 95% CI 0.03 to 9.62; I² = 44%; 2 studies, 165 participants; very low-certainty evidence). We are very uncertain whether use of SPU plus TA impacts AC occlusion rates (RR 1.20, 95% CI 0.37 to 3.91; I² = 3%; 2 studies, 165 participants; very low-certainty evidence). We are very uncertain whether use of SPU plus TA impacts rates of adverse events with few reported events across groups (RR 0.89, 95% CI 0.09 to 8.33; I² = 0%; 2 studies, 165 participants; very low-certainty evidence). Bordered polyurethane (BPU) compared to SPU: we are very uncertain whether use of BPU impacts rates of AC failure (RR 0.67, 95% CI 0.21 to 2.13; 1 study, 60 participants; very low-certainty evidence). BPU may make little or no difference to CRBSI compared to SPU (RR 3.05, 95% CI 0.12 to 74.45; I² = not applicable as 1 study (60 participants) reported 0 events; 2 studies, 572 participants; low-certainty evidence). BPU may make little or no difference to the risk of AC dislodgement compared with SPU (RR 0.75, 95% CI 0.17 to 3.22; I² = 0%; 2 studies, 572 participants; low-certainty evidence). BPU may make little or no difference to occlusion risk compared with SPU (RR 0.80, 95% CI 0.60 to 1.07; I² = 0%; 2 studies, 572 participants; low-certainty evidence). It is very uncertain whether BPU impacts on the risk of adverse events compared with SPU (RR 0.33, 95% CI 0.01 to 7.87; 1 study, 60 participants; very low-certainty evidence). SPU plus sutureless securement devices (SSD) compared to SPU: we are very uncertain whether SPU plus SSD impacts risk of AC failure compared with SPU (RR 0.78, 95% CI 0.40 to 1.52; I² = 0%; 2 studies, 157 participants; very low-certainty evidence). We are very uncertain if SPU plus SSD impacts CRBSI incidence rate with no events in both groups (2 studies, 157 participants; very low-certainty evidence). It is very uncertain whether SPU plus SSD impacts risk of dislodgement (RR 0.14, 95% CI 0.01 to 2.57; I² = not applicable as 1 study (96 participants) reported 0 events; 2 studies, 157 participants; very low-certainty evidence). It is very uncertain whether SPU plus SSD impacts risk of AC occlusion (RR 1.94, 95% CI 0.50 to 7.48; I² = 38%; 2 studies, 157 participants; very low-certainty evidence). We are very uncertain whether SPU plus SSD impacts on the risk of adverse events (RR 1.94, 95% CI 0.19 to 20.24; I² = not applicable as 1 study (96 participants) reported 0 events; 2 studies, 157 participants; very low-certainty evidence). Integrated securement dressings compared to SPU: integrated securement dressings may result in little or no difference in risk of AC failure compared with SPU (RR 1.96, 95% CI 0.80 to 4.84; 1 study, 105 participants; low-certainty evidence); may result in little or no difference in CRBSI incidence with no events reported (1 study, 105 participants; low-certainty evidence); may result in little or no difference in the risk of dislodgement (RR 0.33, 95% CI 0.04 to 3.04; 1 study, 105 participants; low-certainty evidence), may result in little or no difference in occlusion rates with no events reported (1 study, 105 participants; low-certainty evidence), and may result in little or no difference in the risk of adverse events (RR 0.35, 95% CI 0.01 to 8.45; 1 study, 105 participants; low-certainty evidence).
AUTHORS' CONCLUSIONS
There is currently limited rigorous RCT evidence available about the relative clinical effectiveness of AC dressing and securement products. Limitations of current evidence include small sample size, infrequent events, and heterogeneous outcome measurements. We found no clear difference in the incidence of AC failure, CRBSI, or adverse events across AC dressing or securement products including SPU, BPU, SSD, TA, and integrated securement products. The limitations of current evidence means further rigorous RCTs are needed to reduce uncertainty around the use of dressing and securement devices for ACs.
Topics: Humans; Randomized Controlled Trials as Topic; Catheterization, Peripheral; Bandages; Catheter-Related Infections; Polyurethanes; Bias; Equipment Failure
PubMed: 38780138
DOI: 10.1002/14651858.CD013023.pub2 -
The Cochrane Database of Systematic... Mar 2014Amalgam has been the traditional material for filling cavities in posterior teeth for the last 150 years and, due to its effectiveness and cost, amalgam is still the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Amalgam has been the traditional material for filling cavities in posterior teeth for the last 150 years and, due to its effectiveness and cost, amalgam is still the restorative material of choice in certain parts of the world. In recent times, however, there have been concerns over the use of amalgam restorations (fillings), relating to the mercury release in the body and the environmental impact following its disposal. Resin composites have become an esthetic alternative to amalgam restorations and there has been a remarkable improvement of its mechanical properties to restore posterior teeth.There is need to review new evidence comparing the effectiveness of both restorations.
OBJECTIVES
To examine the effects of direct composite resin fillings versus amalgam fillings for permanent posterior teeth, primarily on restoration failure.
SEARCH METHODS
We searched the Cochrane Oral Health Group's Trials Register (to 22 October 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 9), MEDLINE via OVID (1946 to 22 October 2013), EMBASE via OVID (1980 to 22 October 2013), and LILACs via BIREME Virtual Health Library (1980 to 22 October 2013). We applied no restrictions on language or date of publication when searching the electronic databases. We contacted manufacturers of dental materials to obtain any unpublished studies.
SELECTION CRITERIA
Randomized controlled trials comparing dental resin composites with dental amalgams in permanent posterior teeth. We excluded studies having a follow-up period of less than three years.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by The Cochrane Collaboration.
MAIN RESULTS
Of the 2205 retrieved references, we included seven trials (10 articles) in the systematic review. Two trials were parallel group studies involving 1645 composite restorations and 1365 amalgam restorations (921 children) in the analysis. The other five trials were split-mouth studies involving 1620 composite restorations and 570 amalgam restorations in an unclear number of children. Due to major problems with the reporting of the data for the five split-mouth trials, the primary analysis is based on the two parallel group trials. We judged all seven trials to be at high risk of bias and we analyzed 3265 composite restorations and 1935 amalgam restorations.The parallel group trials indicated that resin restorations had a significantly higher risk of failure than amalgam restorations (risk ratio (RR) 1.89, 95% confidence interval (CI) 1.52 to 2.35, P value < 0.001 (fixed-effect model) (low-quality evidence)) and increased risk of secondary caries (RR 2.14, 95% CI 1.67 to 2.74, P value < 0.001 (low-quality evidence)) but no evidence of an increased risk of restoration fracture (RR 0.87, 95% CI 0.46 to 1.64, P value = 0.66 (moderate-quality evidence)). The results from the split-mouth trials were consistent with those of the parallel group trials.Adverse effects of dental restorations were reported in two trials. The outcomes considered were neurobehavioral function, renal function, psychosocial function, and physical development. The investigators found no difference in adverse effects between composite and amalgam restorations. However, the results should be interpreted with caution as none of the outcomes were reported in more than one trial.
AUTHORS' CONCLUSIONS
There is low-quality evidence to suggest that resin composites lead to higher failure rates and risk of secondary caries than amalgam restorations. This review reinforces the benefit of amalgam restorations and the results are particularly useful in parts of the world where amalgam is still the material of choice to restore posterior teeth with proximal caries. Though the review found insufficient evidence to support or refute any adverse effects amalgam may have on patients, new research is unlikely to change opinion on its safety and due to the decision for a global phase-down of amalgam (Minamata Convention on Mercury) general opinion on its safety is unlikely to change.
Topics: Acrylic Resins; Child; Composite Resins; Dental Amalgam; Dental Caries; Dental Restoration Failure; Dental Restoration, Permanent; Dentition, Permanent; Humans; Molar; Polyurethanes; Randomized Controlled Trials as Topic
PubMed: 24683067
DOI: 10.1002/14651858.CD005620.pub2 -
Journal of Plastic, Reconstructive &... Sep 2011Negative pressure wound therapy (NPWT) is becoming a commonplace treatment in many clinical settings. New devices and dressings are being introduced. Despite widespread... (Review)
Review
Evidence-based recommendations for negative pressure wound therapy: treatment variables (pressure levels, wound filler and contact layer)--steps towards an international consensus.
Negative pressure wound therapy (NPWT) is becoming a commonplace treatment in many clinical settings. New devices and dressings are being introduced. Despite widespread adoption, there remains uncertainty regarding several aspects of NPWT use. To respond to these gaps, a global expert panel was convened to develop evidence-based recommendations describing the use of NPWT. In a previous communication, we have reviewed the evidence base for the use of NPWT within trauma and reconstructive surgery. In this communication, we present results of the assessment of evidence relating to the different NPWT treatment variables: different wound fillers (principally foam and gauze); when to use a wound contact layer; different pressure settings; and the impact of NPWT on bacterial bioburden. Evidence-based recommendations were obtained by a systematic review of the literature, grading of evidence and drafting of the recommendations by a global expert panel. Evidence and recommendations were graded according to the Scottish Intercollegiate Guidelines Network (SIGN) classification system. In general, there is relatively weak evidence on which to base recommendations for any one NPWT treatment variable over another. Overall, 14 recommendations were developed: five for the choice of wound filler and wound contact layer, four for choice of pressure setting and five for use of NPWT in infected wounds. With respect to bioburden, evidence suggests that reduction of bacteria in wounds is not a major mode of action of NPWT.
Topics: Anti-Bacterial Agents; Bandages; Cost Savings; Drainage; Evidence-Based Medicine; Humans; Ischemia; Negative-Pressure Wound Therapy; Pain; Polyurethanes; Soft Tissue Infections; Surgical Flaps; Surgical Wound Infection; Wound Healing; Wounds and Injuries
PubMed: 21868296
DOI: 10.1016/j.bjps.2011.06.001