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The Cochrane Database of Systematic... May 2023Pressure ulcers, also known as bedsores, pressure sores, or pressure injuries, are localised damage to the skin and underlying soft tissue, usually caused by intense or... (Review)
Review
BACKGROUND
Pressure ulcers, also known as bedsores, pressure sores, or pressure injuries, are localised damage to the skin and underlying soft tissue, usually caused by intense or long-term pressure, shear, or friction. Negative pressure wound therapy (NPWT) has been widely used in the treatment of pressure ulcers, but its effect needs to be further clarified. This is an update of a Cochrane Review first published in 2015.
OBJECTIVES
To evaluate the effectiveness of NPWT for treating adult with pressure ulcers in any care setting.
SEARCH METHODS
On 13 January 2022, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase, and EBSCO CINAHL Plus. We also searched ClinicalTrials.gov and the WHO ICTRP Search Portal for ongoing and unpublished studies and scanned reference lists of relevant included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication, or study setting.
SELECTION CRITERIA
We included published and unpublished randomised controlled trials (RCTs) comparing the effects of NPWT with alternative treatments or different types of NPWT in the treatment of adults with pressure ulcers (stage II or above).
DATA COLLECTION AND ANALYSIS
Two review authors independently conducted study selection, data extraction, risk of bias assessment using the Cochrane risk of bias tool, and the certainty of the evidence assessment using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology. Any disagreement was resolved by discussion with a third review author.
MAIN RESULTS
This review included eight RCTs with a total of 327 randomised participants. Six of the eight included studies were deemed to be at a high risk of bias in one or more risk of bias domains, and evidence for all outcomes of interest was deemed to be of very low certainty. Most studies had small sample sizes (range: 12 to 96, median: 37 participants). Five studies compared NPWT with dressings, but only one study reported usable primary outcome data (complete wound healing and adverse events). This study had only 12 participants and there were very few events; only one participant was healed in the study (risk ratio (RR) 3.00, 95% confidence interval (CI) 0.15 to 61.74, very low-certainly evidence). There was no evidence of a difference in the number of participants with adverse events in the NPWT group and the dressing group, but the evidence for this outcome was also assessed as very low certainty (RR 1.25, 95% CI 0.64 to 2.44, very low-certainty evidence). Changes in ulcer size, pressure ulcer severity, cost, and pressure ulcer scale for healing (PUSH) sores were also reported, but we were unable to draw conclusions due to the low certainly of the evidence. One study compared NPWT with a series of gel treatments, but this study provided no usable data. Another study compared NPWT with 'moist wound healing', which did not report primary outcome data. Changes in ulcer size and cost were reported in this study, but we assessed the evidence as being of very low certainty; One study compared NPWT combined with internet-plus home care with standard care, but no primary outcome data were reported. Changes in ulcer size, pain, and dressing change times were reported, but we also assessed the evidence as being of very low certainty. None of the included studies reported time to complete healing, health-related quality of life, wound infection, or wound recurrence.
AUTHORS' CONCLUSIONS
The efficacy, safety, and acceptability of NPWT in treating pressure ulcers compared to usual care are uncertain due to the lack of key data on complete wound healing, adverse events, time to complete healing, and cost-effectiveness. Compared with usual care, using NPWT may speed up the reduction of pressure ulcer size and severity of pressure ulcer, reduce pain, and dressing change times. Still, trials were small, poorly described, had short follow-up times, and with a high risk of bias; any conclusions drawn from the current evidence should be interpreted with considerable caution. In the future, high-quality research with large sample sizes and low risk of bias is still needed to further verify the efficacy, safety, and cost-effectiveness of NPWT in the treatment of pressure ulcers. Future researchers need to recognise the importance of complete and accurate reporting of clinically important outcomes such as the complete healing rate, healing time, and adverse events.
Topics: Adult; Humans; Bandages; Negative-Pressure Wound Therapy; Pressure Ulcer; Surgical Wound Infection; Ulcer
PubMed: 37232410
DOI: 10.1002/14651858.CD011334.pub3 -
BMC Geriatrics Mar 2019Many home-dwelling elderly use medical compression stockings to prevent venous insufficiency, deep venous thrombosis, painful legs and leg ulcers. Assisting users with... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Many home-dwelling elderly use medical compression stockings to prevent venous insufficiency, deep venous thrombosis, painful legs and leg ulcers. Assisting users with applying and removing compression stockings demands resources from the home based health services, but the effects are uncertain. This systematic review aims to summarize the effects of preventive use of medical compression stockings for patients with chronic venous insufficiency and swollen legs.
METHODS
We conducted a search in six databases (Epistemonikos, Cochrane Database of Systematic Reviews, MEDLINE, Embase, CENTRAL and CINAHL) in March 2018. Randomized controlled trials evaluating the preventive effects of European standard compression stockings class 3 or 2 for elderly with chronic venous insufficiency and swollen legs were included. Primary outcomes were thrombosis, leg ulcers and mobility. Secondary outcomes were other health related outcomes, e.g. pain, compliance. We assessed risk of bias in the included studies and used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool for evaluating the overall quality of evidence.
RESULTS
Five randomized controlled trials met the inclusion criteria. Comparing compression stockings class 2 to class 1, meta-analysis showed a reduction in leg ulcer recurrence at 12 months (RR 0.52; 95% CI 0.30 to 0.88). The quality of evidence was assessed as moderate by GRADE. One study (100 participants) did not detect a difference between compression stockings class 3 versus class 2 on ulcer recurrence after six months (RR 0.64; 95% CI 0.20 to 2.03). In another study, patients wearing class 3 compression stockings had lower recurrence risk compared with patients without stockings (RR 0.46; 95% CI 0.27 to 0.76) at six months and (RR 0.43; 95% CI 0.27 to 0.69) at 12 months. We found no difference between class 2 and class 1 stockings on subjective symptoms of chronic venous insufficiency or outcomes of vein thrombosis or mobility.
CONCLUSION
Compression stockings class 2 probably reduce the risk of leg ulcer recurrence compared to compression stockings class 1. It is uncertain whether the use of stockings with higher compression grades is associated with a further risk reduction. More randomized controlled trials on vein thrombosis and mobility are needed.
Topics: Aged; Edema; Humans; Lower Extremity; Patient Compliance; Stockings, Compression; Treatment Outcome; Venous Insufficiency
PubMed: 30845919
DOI: 10.1186/s12877-019-1087-1 -
International Journal of Environmental... Oct 2020The aim of this study was to assess the effectiveness of hydrocolloid dressings in the treatment of grade I, II, III, and IV pressure ulcers in adult patients. We... (Meta-Analysis)
Meta-Analysis
The aim of this study was to assess the effectiveness of hydrocolloid dressings in the treatment of grade I, II, III, and IV pressure ulcers in adult patients. We compared the therapeutic effects of hydrocolloids and alternative dressings in pressure ulcer treatment. We conducted a systematic review, using a literature search only in English, from database inception until 20 April 2020, to identify randomized trials comparing various types of dressings applied in the healing of pressure ulcers. The databases were PubMed, Embase, and Cumulative Index to Nursing and Allied Health Literature (CINAHL). The study selection was performed independently by two reviewers. Data were extracted based on the guidelines included in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol. The risk of bias in the included studies was assessed using a standardized critical appraisal instrument developed by the Cochrane Collaboration. Random-effect meta-analysis of data from three or more studies was performed using meta-analysis software (Comprehensive Meta-Analysis V3, Biostat, New Jersey, USA). A total of 1145 records were identified, of which 223 were qualified after further verification, of which eight were finally included in further analysis. Hydrocolloid dressings were not superior to control therapeutics ( = 0.839; Z = 0.203; CI 95%: 0.791-1.334). They were not associated with higher healing rates ( = 0.718; Z = 0.361; OR: 0.067; CI 95%: 0.297-0.431), nor did they decrease the incidence of adverse events compared with control therapeutics ( = 0.300; Z = -1.036; OR: 0.067; CI 95%: 0.394-1.333). In the above cases, Egger's test also did not indicate publication bias (t value = 0.779, = 0.465; t value = 1.198, = 0.442; t value = 0.834, = 0.465, respectively). The present meta-analysis shows that hydrocolloid dressings are not significantly better than alternative ones in the healing of pressure ulcers in adult patients.
Topics: Adult; Bandages, Hydrocolloid; Humans; Incidence; Pressure Ulcer; Wound Healing
PubMed: 33121151
DOI: 10.3390/ijerph17217881 -
Phlebology Aug 2020Medical compression therapy is used for non-invasive treatment of venous and lymphatic diseases. Medical compression therapy-associated adverse events and...
OBJECTIVES
Medical compression therapy is used for non-invasive treatment of venous and lymphatic diseases. Medical compression therapy-associated adverse events and contraindications have been reported, although some contraindications are theoretically based. This consensus statement provides recommendations on medical compression therapy risks and contraindications.
METHODS
A systematic literature search of medical compression therapy publications reporting adverse events up until November 2017 was performed. A consensus panel comprising 15 international experts critically reviewed the publications and formulated the recommendations.
RESULTS
Sixty-two publications reporting medical compression therapy adverse events were identified. The consensus panel issued 21 recommendations on medical compression therapy contraindications and adverse event risk mitigation, in addition to reviewing medical compression therapy use in borderline indications. The most frequently reported non-severe medical compression therapy-associated adverse events included skin irritation, discomfort and pain. Very rare but severe adverse events, including soft tissue and nerve injury, were also identified.
CONCLUSION
This consensus statement summarises published medical compression therapy-associated adverse events and contraindications, and provides guidance on medical compression therapy. Severe medical compression therapy-associated adverse events are very rarely encountered if compression is used correctly and contraindications are considered.
Topics: Compression Bandages; Consensus; Contraindications; Humans; Lymphatic Diseases
PubMed: 32122269
DOI: 10.1177/0268355520909066 -
BMJ Clinical Evidence Jan 2011Varicose veins are caused by poorly functioning valves in the veins, and decreased elasticity of the vein wall, allowing pooling of blood within the veins, and their... (Review)
Review
INTRODUCTION
Varicose veins are caused by poorly functioning valves in the veins, and decreased elasticity of the vein wall, allowing pooling of blood within the veins, and their subsequent enlargement. Varicose veins affect up to 40% of adults, and are more common in obese people, and in women who have had more than two pregnancies.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments in adults with varicose veins? We searched: Medline, Embase, The Cochrane Library and other important databases up to January 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 39 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: compression stockings, endovenous laser, injection sclerotherapy, radiofrequency ablation, self-help (advice, avoidance of tight clothing, diet, elevation of legs, exercise), and surgery (stripping, avulsion, powered phlebectomy).
Topics: Humans; Sclerotherapy; Stockings, Compression; Treatment Outcome; Varicose Veins; Vascular Surgical Procedures
PubMed: 21477400
DOI: No ID Found -
BMJ Clinical Evidence Apr 2011Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers in up to one third of people in hospitals or community care,... (Review)
Review
INTRODUCTION
Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers in up to one third of people in hospitals or community care, and one fifth of nursing home residents. Pressure ulcers are more likely in people with reduced mobility and poor skin condition, such as older people or those with vascular disease.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of preventive interventions in people at risk of developing pressure ulcers? What are the effects of treatments in people with pressure ulcers? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 64 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: air-filled vinyl boots, air-fluidised supports, alternating-pressure surfaces (including mattresses), alternative foam mattresses, constant low-pressure supports, debridement, electric profiling beds, electrotherapy, hydrocellular heel supports, low-air-loss beds (including hydrotherapy beds), low-level laser therapy, low-tech constant-low-pressure supports, medical sheepskin overlays, nutritional supplements, orthopaedic wool padding, pressure-relieving overlays on operating tables, pressure-relieving surfaces, repositioning (regular "turning"), seat cushions, standard beds, standard care, standard foam mattresses, standard tables, surgery, therapeutic ultrasound, topical lotions and dressings, topical negative pressure, and topical phenytoin.
Topics: Anticonvulsants; Bandages; Bedding and Linens; Beds; Debridement; Humans; Low-Level Light Therapy; Negative-Pressure Wound Therapy; Patient Positioning; Phenytoin; Pressure Ulcer; Standard of Care; Ultrasonic Therapy
PubMed: 21524319
DOI: No ID Found -
Wound Management & Prevention Feb 2019Use of a hydrocolloid dressing (HCD) is generally recommended to help prevent pressure ulcers (PUs) in high-risk patients, including ulcers caused by noninvasive... (Meta-Analysis)
Meta-Analysis
UNLABELLED
Use of a hydrocolloid dressing (HCD) is generally recommended to help prevent pressure ulcers (PUs) in high-risk patients, including ulcers caused by noninvasive ventilation (NIV).
PURPOSE
The study was conducted to compare the effect of preventive use of HCD to other methods in the rate of facial PUs caused by NIV.
METHODS
PubMed, Web of Science, China National Knowledge Infrastructure, and Wanfang Data were searched from date of index inception to August 2018 without language restrictions to identify randomized controlled trials (RCTs) that compared HCD use to other NIV-related PU prevention measures. Publications were systematically reviewed, data were extracted, and study quality was assessed using the Jadad scale. Odds ratio (OR) with 95% confidence intervals (CIs) for PU incidence in patients using HCD versus patients managed with gauze or standard skin care procedures (control) were calculated using a fixed-effects model.
RESULTS
The search yielded 80 publications; 40 met the study criteria for full-text and 22 met the meta-analysis inclusion criteria (total study participants = 2519). Patients who used a HCD (n = 1260) had a significantly decreased incidence of PU (OR = 0.15; 95% CI: 0.11-0.20) compared with control group patients (n = 1259). Subgroup analysis by age showed a lower incidence in children (OR = 0.09; 95% CI: 0.01-0.81) and adults (OR = 0.16; 95% CI: 0.12-0.22) in the HCD group than in the control group. PU incidence using HCD was lower compared to gauze (OR = 0.17; 95% CI: 0.10-0.28) and regular skin care (OR = 0.13; 95% CI: 0.09-0.19). Funnel plot diagrams suggested a risk of bias. Sensitivity analysis using a random-effects model did not change the result of the main meta-analysis.
CONCLUSION
Using a HCD significantly decreased the incidence of facial PUs caused by NIV. Additional high-quality, prospective research to confirm the effectiveness of HCD in preventing NIV-related PUs is warranted.
Topics: Bandages, Hydrocolloid; China; Equipment Design; Humans; Incidence; Noninvasive Ventilation; Pressure Ulcer; Prospective Studies; Randomized Controlled Trials as Topic; Wound Healing
PubMed: 30730303
DOI: No ID Found -
The Cochrane Database of Systematic... Dec 2018Pressure ulcers, localised injuries to the skin or underlying tissue, or both, occur when people cannot reposition themselves to relieve pressure on bony prominences.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pressure ulcers, localised injuries to the skin or underlying tissue, or both, occur when people cannot reposition themselves to relieve pressure on bony prominences. These wounds are difficult to heal, painful, expensive to manage and have a negative impact on quality of life. Prevention strategies include nutritional support and pressure redistribution. Dressing and topical agents aimed at prevention are also widely used, however, it remains unclear which, if any, are most effective. This is the first update of this review, which was originally published in 2013.
OBJECTIVES
To evaluate the effects of dressings and topical agents on pressure ulcer prevention, in people of any age, without existing pressure ulcers, but considered to be at risk of developing one, in any healthcare setting.
SEARCH METHODS
In March 2017 we searched the Cochrane Wounds Group Specialised Register, CENTRAL, MEDLINE, MEDLINE (In-Process & Other Non-Indexed Citations), Embase, and EBSCO CINAHL Plus. We searched clinical trials registries for ongoing trials, and bibliographies of relevant publications to identify further eligible trials. There was no restriction on language, date of trial or setting. In May 2018 we updated this search; as a result several trials are awaiting classification.
SELECTION CRITERIA
We included randomised controlled trials that enrolled people at risk of pressure ulcers.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, assessed risk of bias and extracted data.
MAIN RESULTS
The original search identified nine trials; the updated searches identified a further nine trials meeting our inclusion criteria. Of the 18 trials (3629 participants), nine involved dressings; eight involved topical agents; and one included dressings and topical agents. All trials reported the primary outcome of pressure ulcer incidence.Topical agentsThere were five trials comparing fatty acid interventions to different treatments. Two trials compared fatty acid to olive oil. Pooled evidence shows that there is no clear difference in pressure ulcer incidence between groups, fatty acid versus olive oil (2 trials, n=1060; RR 1.28, 95% CI 0.76 to 2.17; low-certainty evidence, downgraded for very serious imprecision; or fatty acid versus standard care (2 trials, n=187; RR 0.70, 95% CI 0.41 to 1.18; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Trials reported that pressure ulcer incidence was lower with fatty acid-containing-treatment compared with a control compound of trisostearin and perfume (1 trial, n=331; RR 0.42, 95% CI 0.22 to 0.80; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Pooled evidence shows that there is no clear difference in incidence of adverse events between fatty acids and olive oil (1 trial, n=831; RR 2.22 95% CI 0.20 to 24.37; low-certainty evidence, downgraded for very serious imprecision).Four trials compared further different topical agents with placebo. Dimethyl sulfoxide (DMSO) cream may increase the risk of pressure ulcer incidence compared with placebo (1 trial, n=61; RR 1.99, 95% CI 1.10 to 3.57; low-certainty evidence; downgraded for serious risk of bias and serious imprecision). The other three trials reported no clear difference in pressure ulcer incidence between active topical agents and control/placebo; active lotion (1 trial, n=167; RR 0.73, 95% CI 0.45 to 1.19), Conotrane (1 trial, n=258; RR 0.74, 95% CI 0.52 to 1.07), Prevasore (1 trial, n=120; RR 0.33, 95% CI 0.04 to 3.11) (very low-certainty evidence, downgraded for very serious risk of bias and very serious imprecision). There was limited evidence from one trial to determine whether the application of a topical agent may delay or prevent the development of a pressure ulcer (Dermalex 9.8 days vs placebo 8.7 days). Further, two out of 76 reactions occurred in the Dermalex group compared with none out of 91 in the placebo group (RR 6.14, 95% CI 0.29 to 129.89; very low-certainty evidence; downgraded for very serious risk of bias and very serious imprecision).DressingsSix trials (n = 1247) compared a silicone dressing with no dressing. Silicone dressings may reduce pressure ulcer incidence (any stage) (RR 0.25, 95% CI 0.16 to 0.41; low-certainty evidence; downgraded for very serious risk of bias). In the one trial (n=77) we rated as being at low risk of bias, there was no clear difference in pressure ulcer incidence between silicone dressing and placebo-treated groups (RR 1.95, 95% CI 0.18 to 20.61; low-certainty evidence, downgraded for very serious imprecision).One trial (n=74) reported no clear difference in pressure ulcer incidence when a thin polyurethane dressing was compared with no dressing (RR 1.31, 95% CI 0.83 to 2.07). In the same trial pressure ulcer incidence was reported to be higher in an adhesive foam dressing compared with no dressing (RR 1.65, 95% CI 1.10 to 2.48). We rated evidence from this trial as very low certainty (downgraded for very serious risk of bias and serious imprecision).Four trials compared other dressings with different controls. Trials reported that there was no clear difference in pressure ulcer incidence between the following comparisons: polyurethane film and hydrocolloid dressing (n=160, RR 0.58, 95% CI 0.24 to 1.41); Kang' huier versus routine care n=100; RR 0.42, 95% CI 0.08 to 2.05); 'pressure ulcer preventive dressing' (PPD) versus no dressing (n=74; RR 0.18, 95% CI 0.04 to 0.76) We rated the evidence as very low certainty (downgraded for very serious risk of bias and serious or very serious imprecision).
AUTHORS' CONCLUSIONS
Most of the trials exploring the impact of topical applications on pressure ulcer incidence showed no clear benefit or harm. Use of fatty acid versus a control compound (a cream that does not include fatty acid) may reduce the incidence of pressure ulcers. Silicone dressings may reduce pressure ulcer incidence (any stage). However the low level of evidence certainty means that additional research is required to confirm these results.
Topics: Administration, Cutaneous; Aged; Allantoin; Bandages; Dimethyl Sulfoxide; Drug Administration Schedule; Drug Combinations; Fatty Acids; Hexachlorophene; Humans; Incidence; Middle Aged; Olive Oil; Pressure Ulcer; Randomized Controlled Trials as Topic; Silicones; Skin Care; Skin Cream; Squalene
PubMed: 30537080
DOI: 10.1002/14651858.CD009362.pub3 -
The Cochrane Database of Systematic... Nov 2018Hospitalised patients are at increased risk of developing deep vein thrombosis (DVT) in the lower limb and pelvic veins, on a background of prolonged immobilisation... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Hospitalised patients are at increased risk of developing deep vein thrombosis (DVT) in the lower limb and pelvic veins, on a background of prolonged immobilisation associated with their medical or surgical illness. Patients with DVT are at increased risk of developing a pulmonary embolism (PE). The use of graduated compression stockings (GCS) in hospitalised patients has been proposed to decrease the risk of DVT. This is an update of a Cochrane Review first published in 2000, and last updated in 2014.
OBJECTIVES
To evaluate the effectiveness and safety of graduated compression stockings in preventing deep vein thrombosis in various groups of hospitalised patients.
SEARCH METHODS
For this review the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), and trials registries on 21 March 2017; and the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE Ovid, Embase Ovid, CINAHL Ebsco, AMED Ovid , and trials registries on 12 June 2018.
SELECTION CRITERIA
Randomised controlled trials (RCTs) involving GCS alone, or GCS used on a background of any other DVT prophylactic method. We combined results from both of these groups of trials.
DATA COLLECTION AND ANALYSIS
Two review authors (AS, MD) assessed potentially eligible trials for inclusion. One review author (AS) extracted the data, which a second review author (MD) cross-checked and authenticated. Two review authors (AS, MD) assessed the methodological quality of trials with the Cochrane 'Risk of bias' tool. Any disagreements were resolved by discussion with the senior review author (TL). For dichotomous outcomes, we calculated the Peto odds ratio and corresponding 95% confidence interval. We pooled data using a fixed-effect model. We used the GRADE system to evaluate the overall quality of the evidence supporting the outcomes assessed in this review.
MAIN RESULTS
We included 20 RCTs involving a total of 1681 individual participants and 1172 individual legs (2853 analytic units). Of these 20 trials, 10 included patients undergoing general surgery; six included patients undergoing orthopaedic surgery; three individual trials included patients undergoing neurosurgery, cardiac surgery, and gynaecological surgery, respectively; and only one trial included medical patients. Graduated compression stockings were applied on the day before surgery or on the day of surgery and were worn up until discharge or until the participants were fully mobile. In the majority of the included studies DVT was identified by the radioactive I uptake test. Duration of follow-up ranged from seven to 14 days. The included studies were at an overall low risk of bias.We were able to pool the data from 20 studies reporting the incidence of DVT. In the GCS group, 134 of 1445 units developed DVT (9%) in comparison to the control group (without GCS), in which 290 of 1408 units developed DVT (21%). The Peto odds ratio (OR) was 0.35 (95% confidence interval (CI) 0.28 to 0.43; 20 studies; 2853 units; high-quality evidence), showing an overall effect favouring treatment with GCS (P < 0.001).Based on results from eight included studies, the incidence of proximal DVT was 7 of 517 (1%) units in the GCS group and 28 of 518 (5%) units in the control group. The Peto OR was 0.26 (95% CI 0.13 to 0.53; 8 studies; 1035 units; moderate-quality evidence) with an overall effect favouring treatment with GCS (P < 0.001). Combining results from five studies, all based on surgical patients, the incidence of PE was 5 of 283 (2%) participants in the GCS group and 14 of 286 (5%) in the control group. The Peto OR was 0.38 (95% CI 0.15 to 0.96; 5 studies; 569 participants; low-quality evidence) with an overall effect favouring treatment with GCS (P = 0.04). We downgraded the quality of the evidence for proximal DVT and PE due to low event rate (imprecision) and lack of routine screening for PE (inconsistency).We carried out subgroup analysis by speciality (surgical or medical patients). Combining results from 19 trials focusing on surgical patients, 134 of 1365 (9.8%) units developed DVT in the GCS group compared to 282 of 1328 (21.2%) units in the control group. The Peto OR was 0.35 (95% CI 0.28 to 0.44; high-quality evidence), with an overall effect favouring treatment with GCS (P < 0.001). Based on results from seven included studies, the incidence of proximal DVT was 7 of 437 units (1.6%) in the GCS group and 28 of 438 (6.4%) in the control group. The Peto OR was 0.26 (95% CI 0.13 to 0.53; 875 units; moderate-quality evidence) with an overall effect favouring treatment with GCS (P < 0.001). We downgraded the evidence for proximal DVT due to low event rate (imprecision).Based on the results from one trial focusing on medical patients admitted following acute myocardial infarction, 0 of 80 (0%) legs developed DVT in the GCS group and 8 of 80 (10%) legs developed DVT in the control group. The Peto OR was 0.12 (95% CI 0.03 to 0.51; low-quality evidence) with an overall effect favouring treatment with GCS (P = 0.004). None of the medical patients in either group developed a proximal DVT, and the incidence of PE was not reported.Limited data were available to accurately assess the incidence of adverse effects and complications with the use of GCS as these were not routinely quantitatively reported in the included studies.
AUTHORS' CONCLUSIONS
There is high-quality evidence that GCS are effective in reducing the risk of DVT in hospitalised patients who have undergone general and orthopaedic surgery, with or without other methods of background thromboprophylaxis, where clinically appropriate. There is moderate-quality evidence that GCS probably reduce the risk of proximal DVT, and low-quality evidence that GCS may reduce the risk of PE. However, there remains a paucity of evidence to assess the effectiveness of GCS in diminishing the risk of DVT in medical patients.
Topics: Hospitalization; Humans; Orthopedic Procedures; Postoperative Complications; Pulmonary Embolism; Randomized Controlled Trials as Topic; Stockings, Compression; Surgical Procedures, Operative; Venous Thrombosis
PubMed: 30390397
DOI: 10.1002/14651858.CD001484.pub4 -
The Cochrane Database of Systematic... Jun 2020The risk of maternal mortality and morbidity is higher after caesarean section than for vaginal birth. With increasing rates of caesarean section, it is important to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The risk of maternal mortality and morbidity is higher after caesarean section than for vaginal birth. With increasing rates of caesarean section, it is important to minimise risks to the mother as much as possible. This review focused on different skin preparations to prevent infection. This is an update of a review last published in 2018.
OBJECTIVES
To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection.
SEARCH METHODS
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (9 July 2019), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised and quasi-randomised trials, evaluating any type of preoperative skin preparation (agents, methods or forms). We included studies presented only as abstracts, if there was enough information to assess risk of bias. Comparisons of interest in this review were between: different antiseptic agents (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different packages of skin preparation including a mix of agents and methods, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. We mainly focused on the comparison between different agents, with and without the use of drapes. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing.
DATA COLLECTION AND ANALYSIS
Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, extracted the data and checked data for accuracy. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included 13 individually-randomised controlled trials (RCTs), with a total of 6938 women who were undergoing caesarean section. Twelve trials (6916 women) contributed data to this review. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in India, Egypt, Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly at low risk of bias for most domains, although high risk of detection bias raised some specific concerns in a number of studies. Length of stay was only reported in one comparison. Antiseptic agents Parachlorometaxylenol with iodine versus iodine alone We are uncertain whether parachlorometaxylenol with iodine made any difference to the incidence of surgical site infection (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.04 to 2.99; 1 trial, 50 women), or endometritis (RR 0.88, 95% CI 0.56 to 1.38; 1 trial, 50 women) when compared with iodine alone, because the certainty of the evidence was very low. Adverse events (maternal or neonatal) were not reported. Chlorhexidine gluconate versus povidone iodine Moderate-certainty evidence suggested that chlorhexidine gluconate, when compared with povidone iodine, probably slightly reduces the incidence of surgical site infection (RR 0.72, 95% CI 0.58 to 0.91; 8 trials, 4323 women). This effect was still present in a sensitivity analysis after removing four trials at high risk of bias for outcome assessment (RR 0.87, 95% CI 0.62 to 1.23; 4 trials, 2037 women). Low-certainty evidence indicated that chlorhexidine gluconate, when compared with povidone iodine, may make little or no difference to the incidence of endometritis (RR 0.95, 95% CI 0.49 to 1.86; 3 trials, 2484 women). It is uncertain whether chlorhexidine gluconate reduces maternal skin irritation or allergic skin reaction (RR 0.64, 95% CI 0.28 to 1.46; 3 trials, 1926 women; very low certainty evidence). One small study (60 women) reported reduced bacterial growth at 18 hours after caesarean section for women who had chlorhexidine gluconate preparation compared with women who had povidone iodine preparation (RR 0.23, 95% CI 0.07 to 0.70). Methods Drape versus no drape This comparison investigated the use of drape versus no drape, following preparation of the skin with antiseptics. Low-certainty evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (RR 1.29, 95% confidence interval (CI) 0.97 to 1.71; 3 trials, 1373 women), and probably makes little or no difference to the length of stay in the hospital (mean difference (MD) 0.10 days, 95% CI -0.27 to 0.46; 1 trial, 603 women; moderate-certainty evidence). One trial compared an alcohol scrub and iodophor drape with a five-minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very-low certainty evidence). We were uncertain whether the combination of a one-minute alcohol scrub and a drape reduced the incidence of metritis when compared with a five-minute scrub, because the certainty of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The studies did not report on adverse events (maternal or neonatal).
AUTHORS' CONCLUSIONS
Moderate-certainty evidence suggests that preparing the skin with chlorhexidine gluconate before caesarean section is probably slightly more effective at reducing the incidence of surgical site infection in comparison to povidone iodine. For other outcomes examined there was insufficient evidence available from the included RCTs. Most of the evidence in this review was deemed to be very low or low certainty. This means that for most findings, our confidence in any evidence of an intervention effect is limited, and indicates the need for more high-quality research. Therefore, it is not yet clear what sort of skin preparation may be most effective for preventing postcaesarean surgical site infection, or for reducing other undesirable outcomes for mother and baby. Well-designed RCTs, with larger sample sizes are needed. High-priority questions include comparing types of antiseptic (especially iodine versus chlorhexidine), and application methods (scrubbing, swabbing, or draping). We found two studies that are ongoing; we will incorporate the results of these studies in future updates of this review.
Topics: Adult; Anti-Infective Agents, Local; Bandages; Cesarean Section; Chlorhexidine; Endometritis; Ethanol; Female; Humans; Iodine; Iodophors; Length of Stay; Povidone-Iodine; Pregnancy; Preoperative Care; Randomized Controlled Trials as Topic; Surgical Drapes; Surgical Wound Infection; Xylenes
PubMed: 32580252
DOI: 10.1002/14651858.CD007462.pub5