Clinical and cost outcomes of a polyethylene glycol (PEG)-coated patch versus drainage after axillary lymph node dissection in breast cancer: results from a multicentre randomized clinical trial.

BACKGROUND: The aim of this study was to compare the clinical outcomes between breast cancer patients who underwent axillary lymph node dissection with postoperative management using a polyethylene glycol-coated patch versus axillary drainage. The direct costs associated with both postoperative management strategies were also evaluated. METHODS: This was a multicentre RCT in women with breast cancer who underwent axillary lymph node dissection (ClinicalTrials.gov identifier: NCT04487561). Patients were randomly assigned (1 : 1) to receive either drainage or a polyethylene glycol-coated patch as postoperative management. The primary endpoints were the need for an emergency department visit for any event related to the surgery and the rate of seroma development. RESULTS: A total of 227 patients were included , 115 in the patch group (50.7 per cent) and 112 (29.4 per cent ) in the drainage group. The incidence of emergency department visits was significantly greater for patients with drainage versus a polyethylene glycol-coated patch (incidence rate difference 26.1 per cent, 95 per cent c.i. 14.5 to 37.7 per cent; P < 0.001). Conversely, the seroma rate was significantly higher in the polyethylene glycol-coated patch group (incidence rate difference 22.8 per cent, 95 per cent c.i. 6.7 to 38.9 per cent; P < 0.0055). Compared with drainage, using a polyethylene glycol-coated patch resulted in cost savings of €100.41 per patient. An incremental cost-effectiveness ratio analysis found that drainage was associated with an incremental cost-effectiveness ratio of €7594.4 for no need for hospital admission and €491.7 for no need for an emergency department visit. CONCLUSION: Compared with patients who received drainage after axillary lymph node dissection, the use of a polyethylene glycol-coated patch resulted in a higher rate of seroma, but a lower number of postoperative outpatient or emergency department visits and thus a reduction in overall costs.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). Existing evidence for the effectiveness of NPWT on postoperative wounds healing by primary closure remains uncertain. OBJECTIVES: To assess the effects of NPWT for preventing SSI in wounds healing through primary closure, and to assess the cost-effectiveness of NPWT in wounds healing through primary closure. SEARCH METHODS: In January 2021, 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 clinical trials registries and references of included studies, systematic reviews and health technology reports. There were no restrictions on language, publication date or study setting. SELECTION CRITERIA: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, assessment using the Cochrane risk of bias tool, and quality assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. Our primary outcomes were SSI, mortality, and wound dehiscence. MAIN RESULTS: In this fourth update, we added 18 new randomised controlled trials (RCTs) and one new economic study, resulting in a total of 62 RCTs (13,340 included participants) and six economic studies. Studies evaluated NPWT in a wide range of surgeries, including orthopaedic, obstetric, vascular and general procedures. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain. Primary outcomes Eleven studies (6384 participants) which reported mortality were pooled. There is low-certainty evidence showing there may be a reduced risk of death after surgery for people treated with NPWT (0.84%) compared with standard dressings (1.17%) but there is uncertainty around this as confidence intervals include risk of benefits and harm; risk ratio (RR) 0.78 (95% CI 0.47 to 1.30; I2 = 0%). Fifty-four studies reported SSI; 44 studies (11,403 participants) were pooled. There is moderate-certainty evidence that NPWT probably results in fewer SSIs (8.7% of participants) than treatment with standard dressings (11.75%) after surgery; RR 0.73 (95% CI 0.63 to 0.85; I2 = 29%). Thirty studies reported wound dehiscence; 23 studies (8724 participants) were pooled. There is moderate-certainty evidence that there is probably little or no difference in dehiscence between people treated with NPWT (6.62%) and those treated with standard dressing (6.97%), although there is imprecision around the estimate that includes risk of benefit and harms; RR 0.97 (95% CI 0.82 to 1.16; I2 = 4%). Evidence was downgraded for imprecision, risk of bias, or a combination of these. Secondary outcomes There is low-certainty evidence for the outcomes of reoperation and seroma; in each case, confidence intervals included both benefit and harm. There may be a reduced risk of reoperation favouring the standard dressing arm, but this was imprecise: RR 1.13 (95% CI 0.91 to 1.41; I2 = 2%; 18 trials; 6272 participants). There may be a reduced risk of seroma for people treated with NPWT but this is imprecise: the RR was 0.82 (95% CI 0.65 to 1.05; I2 = 0%; 15 trials; 5436 participants). For skin blisters, there is low-certainty evidence that people treated with NPWT may be more likely to develop skin blisters compared with those treated with standard dressing (RR 3.55; 95% CI 1.43 to 8.77; I2 = 74%; 11 trials; 5015 participants). The effect of NPWT on haematoma is uncertain (RR 0.79; 95 % CI 0.48 to 1.30; I2 = 0%; 17 trials; 5909 participants; very low-certainty evidence). There is low-certainty evidence of little to no difference in reported pain between groups. Pain was measured in different ways and most studies could not be pooled; this GRADE assessment is based on all fourteen trials reporting pain; the pooled RR for the proportion of participants who experienced pain was 1.52 (95% CI 0.20, 11.31; I2 = 34%; two studies; 632 participants). Cost-effectiveness Six economic studies, based wholly or partially on trials in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in five indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty; coronary artery bypass grafts; and vascular surgery with inguinal incisions. They calculated quality-adjusted life-years or an equivalent, and produced estimates of the treatments' relative cost-effectiveness. The reporting quality was good but the evidence certainty varied from moderate to very low. There is moderate-certainty evidence that NPWT in surgery for lower limb fracture was not cost-effective at any threshold of willingness-to-pay and that NPWT is probably cost-effective in obese women undergoing caesarean section. Other studies found low or very low-certainty evidence indicating that NPWT may be cost-effective for the indications assessed. AUTHORS' CONCLUSIONS: People with primary closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSIs  than people treated with standard dressings but there is probably no difference in wound dehiscence (moderate-certainty evidence). There may be a reduced risk of death after surgery for people treated with NPWT compared with standard dressings but there is uncertainty around this as confidence intervals include risk of benefit and harm (low-certainty evidence). People treated with NPWT may experience more instances of skin blistering compared with standard dressing treatment (low-certainty evidence). There are no clear differences in other secondary outcomes where most evidence is low or very low-certainty. Assessments of cost-effectiveness of NPWT produced differing results in different indications. There is a large number of ongoing studies, the results of which may change the findings of this review. Decisions about use of NPWT should take into account surgical indication and setting and consider evidence for all outcomes.

Patient-Directed Home Drain Removal in Head and Neck Surgery.

OBJECTIVES/HYPOTHESIS: The purpose of this study was to evaluate the efficacy and safety of at home drain removal in head and neck surgery patients. METHODS: The study population included patients who underwent head and neck surgery at an academic tertiary care center between February 2020 and November 2020 and were discharged with one to four drains with instructions for home removal. Prior to discharge, patients received thorough drain removal education. Patients were prospectively followed to evaluate for associated outcomes. RESULTS: One hundred patients were evaluated in the study. There was record for ninety-seven patients receiving education at discharge. The most common methods of education were face-to-face education and written instructions with educational video link provided. Of 123 drains upon discharge, 110 drains (89.4%) were removed at home while 13 (10.6%) were removed in office. Most drains were located in the neck (86.4%). There was one seroma, two hematomas, two drain site infections, and five ED visits; however, none of these complications were directly associated with the action of drain removal at home. Calculated cost savings for travel and lost wages was $259.82 per round trip saved. CONCLUSIONS: The results demonstrate that home drain removal can provide a safe and efficacious option for patients following head and neck surgery. This approach was safe and associated with patient cost savings and better utilization of provider's time. Furthermore, patients and healthcare providers avoided additional in-person encounters and exposures during the COVID-19 pandemic. Our findings warrant further investigation into cost savings and formal patient satisfaction associated with home drain removal. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2471-2477, 2021.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). Existing evidence for the effectiveness of NPWT on postoperative wounds healing by primary closure remains uncertain. OBJECTIVES: To assess the effects of NPWT for preventing SSI in wounds healing through primary closure, and to assess the cost-effectiveness of NPWT in wounds healing through primary closure. SEARCH METHODS: In June 2019, 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 clinical trials registries and references of included studies, systematic reviews and health technology reports. There were no restrictions on language, publication date or study setting. SELECTION CRITERIA: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another type of NPWT. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, assessment using the Cochrane 'Risk of bias' tool, and quality assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. MAIN RESULTS: In this third update, we added 15 new randomised controlled trials (RCTs) and three new economic studies, resulting in a total of 44 RCTs (7447 included participants) and five economic studies. Studies evaluated NPWT in the context of a wide range of surgeries including orthopaedic, obstetric, vascular and general procedures. Economic studies assessed NPWT in orthopaedic, obstetric and general surgical settings. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain. Primary outcomes Four studies (2107 participants) reported mortality. There is low-certainty evidence (downgraded twice for imprecision) showing no clear difference in the risk of death after surgery for people treated with NPWT (2.3%) compared with standard dressings (2.7%) (risk ratio (RR) 0.86; 95% confidence interval (CI) 0.50 to 1.47; I2 = 0%). Thirty-nine studies reported SSI; 31 of these (6204 participants), were included in meta-analysis. There is moderate-certainty evidence (downgraded once for risk of bias) that NPWT probably results in fewer SSI (8.8% of participants) than treatment with standard dressings (13.0% of participants) after surgery; RR 0.66 (95% CI 0.55 to 0.80 ; I2 = 23%). Eighteen studies reported dehiscence; 14 of these (3809 participants) were included in meta-analysis. There is low-certainty evidence (downgraded once for risk of bias and once for imprecision) showing no clear difference in the risk of dehiscence after surgery for NPWT (5.3% of participants) compared with standard dressings (6.2% of participants) (RR 0.88, 95% CI 0.69 to 1.13; I2 = 0%). Secondary outcomes There is low-certainty evidence showing no clear difference between NPWT and standard treatment for the outcomes of reoperation and incidence of seroma. For reoperation, the RR was 1.04 (95% CI 0.78 to 1.41; I2 = 13%; 12 trials; 3523 participants); for seroma, the RR was 0.72 (95% CI 0.50 to 1.05; I2 = 0%; seven trials; 729 participants). The effect of NPWT on occurrence of haematoma or skin blisters is uncertain (very low-certainty evidence); for haematoma, the RR was 0.67 (95% CI 0.28 to 1.59; I2 = 0%; nine trials; 1202 participants) and for blisters the RR was 2.64 (95% CI 0.65 to 10.68; I2 = 69%; seven trials; 796 participants). The overall effect of NPWT on pain is uncertain (very low-certainty evidence from seven trials (2218 participants) which reported disparate measures of pain); but moderate-certainty evidence suggests there is probably little difference between the groups in pain after three or six months following surgery for lower limb fracture (one trial, 1549 participants). There is also moderate-certainty evidence for women undergoing caesarean sections (one trial, 876 participants) and people having surgery for lower limb fractures (one trial, 1549 participants) that there is probably little difference in quality of life scores at 30 days or 3 or 6 months, respectively. Cost-effectiveness Five economic studies, based wholly or partially on trials included in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in four indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty and coronary artery bypass graft surgery. They calculated quality-adjusted life-years for treatment groups and produced estimates of the treatments' relative cost-effectiveness. The reporting quality was good but the grade of the evidence varied from moderate to very low. There is moderate-certainty evidence that NPWT in surgery for lower limb fracture was not cost-effective at any threshold of willingness-to-pay and that NPWT is probably cost-effective in obese women undergoing caesarean section. Other studies found low or very low-certainty evidence indicating that NPWT may be cost-effective for the indications assessed. AUTHORS' CONCLUSIONS: People experiencing primary wound closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSI than people treated with standard dressings (moderate-certainty evidence). There is no clear difference in number of deaths or wound dehiscence between people treated with NPWT and standard dressings (low-certainty evidence). There are also no clear differences in secondary outcomes where all evidence was low or very low-certainty. In caesarean section in obese women and surgery for lower limb fracture, there is probably little difference in quality of life scores (moderate-certainty evidence). Most evidence on pain is very low-certainty, but there is probably no difference in pain between NPWT and standard dressings after surgery for lower limb fracture (moderate-certainty evidence). Assessments of cost-effectiveness of NPWT produced differing results in different indications. There is a large number of ongoing studies, the results of which may change the findings of this review. Decisions about use of NPWT should take into account surgical indication and setting and consider evidence for all outcomes.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). Existing evidence for the effectiveness of NPWT on postoperative wounds healing by primary closure remains uncertain. OBJECTIVES: To assess the effects of NPWT for preventing SSI in wounds healing through primary closure, and to assess the cost-effectiveness of NPWT in wounds healing through primary closure. SEARCH METHODS: In June 2019, 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 clinical trials registries and references of included studies, systematic reviews and health technology reports. There were no restrictions on language, publication date or study setting. SELECTION CRITERIA: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another type of NPWT. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, assessment using the Cochrane 'Risk of bias' tool, and quality assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. MAIN RESULTS: In this third update, we added 15 new randomised controlled trials (RCTs) and three new economic studies, resulting in a total of 44 RCTs (7447 included participants) and five economic studies. Studies evaluated NPWT in the context of a wide range of surgeries including orthopaedic, obstetric, vascular and general procedures. Economic studies assessed NPWT in orthopaedic, obstetric and general surgical settings. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain. Primary outcomes Four studies (2107 participants) reported mortality. There is low-certainty evidence (downgraded twice for imprecision) showing no clear difference in the risk of death after surgery for people treated with NPWT (2.3%) compared with standard dressings (2.7%) (risk ratio (RR) 0.86; 95% confidence interval (CI) 0.50 to 1.47; I2 = 0%). Thirty-nine studies reported SSI; 31 of these (6204 participants), were included in meta-analysis. There is moderate-certainty evidence (downgraded once for risk of bias) that NPWT probably results in fewer SSI (8.8% of participants) than treatment with standard dressings (13.0% of participants) after surgery; RR 0.66 (95% CI 0.55 to 0.80 ; I2 = 23%). Eighteen studies reported dehiscence; 14 of these (3809 participants) were included in meta-analysis. There is low-certainty evidence (downgraded once for risk of bias and once for imprecision) showing no clear difference in the risk of dehiscence after surgery for NPWT (5.3% of participants) compared with standard dressings (6.2% of participants) (RR 0.88, 95% CI 0.69 to 1.13; I2 = 0%). Secondary outcomes There is low-certainty evidence showing no clear difference between NPWT and standard treatment for the outcomes of reoperation and incidence of seroma. For reoperation, the RR was 1.04 (95% CI 0.78 to 1.41; I2 = 13%; 12 trials; 3523 participants); for seroma, the RR was 0.72 (95% CI 0.50 to 1.05; I2 = 0%; seven trials; 729 participants). The effect of NPWT on occurrence of haematoma or skin blisters is uncertain (very low-certainty evidence); for haematoma, the RR was 0.67 (95% CI 0.28 to 1.59; I2 = 0%; nine trials; 1202 participants) and for blisters the RR was 2.64 (95% CI 0.65 to 10.68; I2 = 69%; seven trials; 796 participants). The overall effect of NPWT on pain is uncertain (very low-certainty evidence from seven trials (2218 participants) which reported disparate measures of pain); but moderate-certainty evidence suggests there is probably little difference between the groups in pain after three or six months following surgery for lower limb fracture (one trial, 1549 participants). There is also moderate-certainty evidence for women undergoing caesarean sections (one trial, 876 participants) and people having surgery for lower limb fractures (one trial, 1549 participants) that there is probably little difference in quality of life scores at 30 days or 3 or 6 months, respectively. Cost-effectiveness Five economic studies, based wholly or partially on trials included in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in four indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty and coronary artery bypass graft surgery. They calculated quality-adjusted life-years for treatment groups and produced estimates of the treatments' relative cost-effectiveness. The reporting quality was good but the grade of the evidence varied from moderate to very low. There is moderate-certainty evidence that NPWT in surgery for lower limb fracture was not cost-effective at any threshold of willingness-to-pay and that NPWT is probably cost-effective in obese women undergoing caesarean section. Other studies found low or very low-certainty evidence indicating that NPWT may be cost-effective for the indications assessed. AUTHORS' CONCLUSIONS: People experiencing primary wound closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSI than people treated with standard dressings (moderate-certainty evidence). There is no clear difference in number of deaths or wound dehiscence between people treated with NPWT and standard dressings (low-certainty evidence). There are also no clear differences in secondary outcomes where all evidence was low or very low-certainty. In caesarean section in obese women and surgery for lower limb fracture, there is probably little difference in quality of life scores (moderate-certainty evidence). Most evidence on pain is very low-certainty, but there is probably no difference in pain between NPWT and standard dressings after surgery for lower limb fracture (moderate-certainty evidence). Assessments of cost-effectiveness of NPWT produced differing results in different indications. There is a large number of ongoing studies, the results of which may change the findings of this review. Decisions about use of NPWT should take into account surgical indication and setting and consider evidence for all outcomes.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). While existing evidence for the effectiveness of NPWT remains uncertain, new trials necessitated an updated review of the evidence for the effects of NPWT on postoperative wounds healing by primary closure. OBJECTIVES: To assess the effects of negative pressure wound therapy for preventing surgical site infection in wounds healing through primary closure. SEARCH METHODS: We searched the Cochrane Wounds Specialised Register, CENTRAL, Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL Plus in February 2018. We also searched clinical trials registries for ongoing and unpublished studies, and checked reference lists of relevant included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions on language, publication date, or setting. SELECTION CRITERIA: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another type of NPWT. DATA COLLECTION AND ANALYSIS: Four review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and quality assessment according to GRADE methodology. MAIN RESULTS: In this second update we added 25 intervention trials, resulting in a total of 30 intervention trials (2957 participants), and two economic studies nested in trials. Surgeries included abdominal and colorectal (n = 5); caesarean section (n = 5); knee or hip arthroplasties (n = 5); groin surgery (n = 5); fractures (n = 5); laparotomy (n = 1); vascular surgery (n = 1); sternotomy (n = 1); breast reduction mammoplasty (n = 1); and mixed (n = 1). In three key domains four studies were at low risk of bias; six studies were at high risk of bias; and 20 studies were at unclear risk of bias. We judged the evidence to be of low or very low certainty for all outcomes, downgrading the level of the evidence on the basis of risk of bias and imprecision.Primary outcomesThree studies reported mortality (416 participants; follow-up 30 to 90 days or unspecified). It is uncertain whether NPWT has an impact on risk of death compared with standard dressings (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.25 to 1.56; very low-certainty evidence, downgraded once for serious risk of bias and twice for very serious imprecision).Twenty-five studies reported on SSI. The evidence from 23 studies (2533 participants; 2547 wounds; follow-up 30 days to 12 months or unspecified) showed that NPWT may reduce the rate of SSIs (RR 0.67, 95% CI 0.53 to 0.85; low-certainty evidence, downgraded twice for very serious risk of bias).Fourteen studies reported dehiscence. We combined results from 12 studies (1507 wounds; 1475 participants; follow-up 30 days to an average of 113 days or unspecified) that compared NPWT with standard dressings. It is uncertain whether NPWT reduces the risk of wound dehiscence compared with standard dressings (RR 0.80, 95% CI 0.55 to 1.18; very low-certainty evidence, downgraded twice for very serious risk of bias and once for serious imprecision).Secondary outcomesWe are uncertain whether NPWT increases or decreases reoperation rates when compared with a standard dressing (RR 1.09, 95% CI 0.73 to 1.63; 6 trials; 1021 participants; very low-certainty evidence, downgraded for very serious risk of bias and serious imprecision) or if there is any clinical benefit associated with NPWT for reducing wound-related readmission to hospital within 30 days (RR 0.86, 95% CI 0.47 to 1.57; 7 studies; 1271 participants; very low-certainty evidence, downgraded for very serious risk of bias and serious imprecision). It is also uncertain whether NPWT reduces incidence of seroma compared with standard dressings (RR 0.67, 95% CI 0.45 to 1.00; 6 studies; 568 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and once for serious imprecision). It is uncertain if NPWT reduces or increases the risk of haematoma when compared with a standard dressing (RR 1.05, 95% CI 0.32 to 3.42; 6 trials; 831 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and twice for very serious imprecision. It is uncertain if there is a higher risk of developing blisters when NPWT is compared with a standard dressing (RR 6.64, 95% CI 3.16 to 13.95; 6 studies; 597 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and twice for very serious imprecision).Quality of life was not reported separately by group but was used in two economic evaluations to calculate quality-adjusted life years (QALYs). There was no clear difference in incremental QALYs for NPWT relative to standard dressing when results from the two trials were combined (mean difference 0.00, 95% CI -0.00 to 0.00; moderate-certainty evidence).One trial concluded that NPWT may be more cost-effective than standard care, estimating an incremental cost-effectiveness ratio (ICER) value of GBP 20.65 per QALY gained. A second cost-effectiveness study estimated that when compared with standard dressings NPWT was cost saving and improved QALYs. We rated the overall quality of the reports as very good; we did not grade the evidence beyond this as it was based on modelling assumptions. AUTHORS' CONCLUSIONS: Despite the addition of 25 trials, results are consistent with our earlier review, with the evidence judged to be of low or very low certainty for all outcomes. Consequently, uncertainty remains about whether NPWT compared with a standard dressing reduces or increases the incidence of important outcomes such as mortality, dehiscence, seroma, or if it increases costs. Given the cost and widespread use of NPWT for SSI prophylaxis, there is an urgent need for larger, well-designed and well-conducted trials to evaluate the effects of newer NPWT products designed for use on clean, closed surgical incisions. Such trials should initially focus on wounds that may be difficult to heal, such as sternal wounds or incisions on obese patients.

Late Shoulder-Arm Morbidity Using Ultrasound Scalpel in Axillary Dissection for Breast Cancer: A Retrospective Analysis.

BACKGROUND: We aimed to assess whether the use of the harmonic scalpel (HS) in axillary dissection would reduce long-term shoulder-arm morbidity compared to traditional instruments (TIs). MATERIALS AND METHODS: A retrospective analysis on 180 patients who underwent standard axillary dissection for breast cancer between 2007 and 2015 was carried out. All patients were evaluated for postoperative pain, impairment of shoulder-arm mobility, seroma formation in axilla, frozen shoulder, and lymphedema. RESULTS: HS procedure on average was 50% shorter compared to the TI technique. HS reduced by 4.5 times the risk of axillary seroma. TIs were associated with 4 times higher risk of developing a painful frozen shoulder. CONCLUSIONS: Use of the HS was associated with reduced costs and a positive long-term effect on shoulder-arm morbidity. Axillary seromas are not the only reason of later postoperative shoulder-arm morbidity: other mechanisms are hypothesized in the onset of this very disabling disorder.

[Comparación entre ligadura con lazo hemostático y engrapadora mecánica lineal para el cierre de base apendicular]. / Comparison between endoloop and linear mechanical stapler for the appendicular stump closure.

INTRODUCCIÓN: En las últimas décadas es creciente el abordaje por mínima invasión de patologías abdominales debido a sus beneficios evidentes. El cuadro apendicular es la principal emergencia quirúrgica, con diferentes métodos del cierre de la base apendicular. En este artículo comparamos dicho cierre con engrapadora lineal o ligadura con lazo hemostático, para analizar la frecuencia de complicaciones como absceso, dehiscencia y seroma. MÉTODO: Se realizó un estudio prospectivo, observacional y descriptivo, con un total de 703 procedimientos, empleando en 567 pacientes ligadura con lazo hemostático y en 136 engrapadora lineal, operados por los mismos cirujano y equipo quirúrgico, con curva de aprendizaje concluida. RESULTADOS: Las complicaciones referidas en el presente estudio son absceso (n = 5), dehiscencia (n = 3) y seroma (n = 3). De acuerdo con las fases de la patología apendicular: fase 1 o apéndice congestivo, no presentaron complicaciones; fase 2 o supurativo, se reportó un caso de dehiscencia de herida quirúrgica con el uso de ligadura con lazo hemostático; fase 3 o necrótico, se reportó un caso de seroma en un paciente tratado con ligadura con lazo hemostático; y fase 4 o perforado, se encuentra diferencia significativa en el caso de abscesos, reportando cinco con el uso de ligadura con lazo hemostático y ninguno con engrapadora lineal. CONCLUSIONES: En nuestro estudio no existe diferencia estadísticamente significativa entre el uso de engrapadora lineal o ligadura con lazo hemostático en las fases apendiculares 1-3; en la fase 4 es de utilidad significativa el uso de engrapadora lineal ante la incidencia de abscesos. INTRODUCTION: In the last decades, the approach by minimally invasive surgery of abdominal pathologies is growing due to its evident benefits; the appendicular cases being the main surgical emergency, with different methods of closing the appendicular base. In this article, we compared the appendicular base closure with linear stapler and endoloop, to analyze the frequency of complications such as abscess, dehiscence and seroma. METHOD: A prospective, observational and descriptive study was conducted, with a total of 703 procedures, using 567 endoloop patients and 136 linear stapler, operated by the same surgeon and surgical team, with a completed learning curve. RESULTS: The complications referred in the present study were patients with abscess (n = 5), dehiscence (n = 3) and seroma (n = 3). According to the phases of the appendiceal pathology: phase 1 or congestive appendix did not present complications; phase 2 or suppurative was reported one case of surgical wound dehiscence in the use of endoloop; in phase 3 or necrotic, one case of seroma was reported in a patient treated with endoloop; while in phase 4 or perforated there is a significant difference in the case of abscesses, reporting five in the use of endoloop and none in the case of a linear stapler. CONCLUSIONS: In our study there is no statistically significant difference between the use of linear stapler or endoloop in the early appendicular phases; being of significant utility in Phase 4 the use of linear stapler for the incidence of abscesses.

Creation of a novel risk score for surgical site infection and occurrence after ventral hernia repair.

BACKGROUND: Complex ventral hernia repair (VHR) is a common surgical operation but carries a risk of complications from surgical site infections (SSI) and occurrences (SSO). We aimed to create a predictive risk score to identify patients at increased risk for SSO or SSI within 30 days of surgery. METHODS: Data were prospectively collected on all patients undergoing VHR between January 2008 and February 2015 by a single surgeon. Multivariable logistic regression was used to identify independent factors predictive of SSO and SSI. Significant predictors of SSO and SSI were assigned point values based on their odds ratios to create a novel risk score, the Hopkins ventral hernia repair SSO/SSI risk score; predicted and actual rates of outcomes were then compared using weighted regression. RESULTS: During the study period, 362 patients underwent open VHR. Thirty-day SSO and SSI occurred in 18.5 and 10% of patients, respectively. After risk adjustment, ASA class ≥3 (1 point), operative time ≥4 h (2 points), and the absence of a postoperative wound vacuum dressing (1 point) were predictive of 30-day SSO. Predicted risk of SSO utilizing this scoring system was 9.7, 19.4, 29.1, and 38.8% for 1, 2, 3, and 4 points (AUC = 0.73). For SSI, operative time ≥4 h (1 point) and the lack of a wound vacuum dressing (1 point) were predictive. Predicted risk of SSI based on this scoring system was 12.5% for 1 point and 25% for 2 points (AUC = 0.71). Actual vs. predicted rates of SSO and SSI correlated strongly for risk model with a coefficient of determination (R 2) of 0.92 and 0.91, respectively. CONCLUSION: The novel Hopkins ventral hernia repair risk score accurately predicts risk of SSO and SSI after complex VHR. Further studies using a prospective randomized controlled trial will be needed to further validate our findings.

A comparison of patient-centered economic and clinical outcomes of post-mastectomy breast reconstruction between obese and non-obese patients.

BACKGROUND: The objectives of this study were to compare, by patient obesity status, the contemporary utilization patterns of different reconstruction surgery types, understand postoperative complication profiles in the community setting, and analyze the financial impact on health care payers and patients. METHODS: Using data from the MarketScan Health Risk Assessment Database and Commercial Claims and Encounters Database, we identified breast cancer patients who received breast reconstruction surgery following mastectomy between 2009 and 2012. The Cochran-Armitage test was used to evaluate the utilization pattern of breast reconstruction surgery. Multivariable logistic regressions were used to estimate the association between obesity status and infectious, wound, and perfusion complications within one year of surgery. A generalized linear model was used to compare total, complication-related, and out-of-pocket costs. RESULTS: The rate of TE/implant-based reconstruction increased significantly for non-obese patients but not for obese patients during the years analyzed, whereas autologous reconstruction decreased for both patient groups. Obesity was associated with higher odds of infectious, wound, and perfusion complications after TE/implant-based reconstruction, and higher odds of perfusion complications after autologous reconstruction. The adjusted total healthcare costs and out-of-pocket costs were similar for obese and non-obese patients for either type of breast reconstruction surgery. CONCLUSIONS: A greater likelihood of one-year complications arose from TE/implant-based vs autologous reconstruction surgery in obese patients. Given that out-of-pocket costs were independent of the type of reconstruction, greater emphasis should be placed on conveying the surgery-related complications to obese patients to aid in patient-based decision making with their plastic surgeons and oncologists.

A meta-analysis of randomized controlled trials of fixation versus nonfixation of mesh in laparoscopic total extraperitoneal inguinal hernia repair.

BACKGROUND: Mesh fixation during laparoscopic total extraperitoneal (TEP) inguinal hernia repair is still controversial. Although many surgeons considered it necessary to fix the mesh, some published studies supported elimination of mesh fixation. Therefore, a meta-analysis based on randomized controlled trials (RCTs) was conducted to compare the effectiveness and safety of fixation versus nonfixation of mesh in TEP. METHODS: RCTs were identified from PubMed, Embase, the Cochrane Library, SCI, and the Chinese Biomedical Literature Database (CBM). Two reviewers assessed the quality of the studies and extracted data independently. The methodological quality was evaluated according to the Cochrane Handbook 5.0.2. Statistical analysis was conducted using the Cochrane software RevMan 5.0.21. RESULTS: Six RCTs involving 772 patients were included. The nonfixation group had advantages in length of hospital stay [MD =-0.37, 95% CI (-0.57, -0.17), p = 0.0003], operative time [MD = -4.19, 95% CI (-7.77, -0.61), p = 0.02], and costs. However, there was no statistically significant difference in hernia recurrence [OR = 2.01, 95% CI (0.37, 11.03), p = 0.42], time to return to normal activities [MD = -0.13, 95% CI (-0.45, 0.19), p = 0.43], seroma [OR = 1.25, 95% CI (0.30, 5.18), p = 0.75], and postoperative pain on postoperative day 1 [MD = -0.21, 95% CI (-0.52, 0.10), p = 0.18] and day 7 [MD = -0.11, 95% CI (-0.42, 0.20), p = 0.47]. CONCLUSIONS: Without increasing the risk of early hernia recurrence, the nonfixation of mesh in TEP appears to be a safe alternative that is associated with less costs, shorter operative time, and hospital stay for the selected patients. Further adequately powered RCTs are required to clarify whether mesh fixation is necessary for the patients with different types of hernias and larger hernia defects.

Incidence and management of seroma after arteriovenous graft placement.

BACKGROUND: Perigraft seromas are rare complications of insertion of PTFE hemodialysis grafts. They are often difficult to treat and recurrence is common. This study evaluates the incidence, potential etiologic variables, and management strategies for seromas after prosthetic arteriovenous graft (AVG) placement. STUDY DESIGN: A retrospective analysis of all patients undergoing AVG placement between August 2002 and December 2005 was performed to identify all patients diagnosed with seroma requiring surgical intervention. Multiple variables were analyzed to determine potential risk factors for seroma formation and outcomes of various forms of surgical management. RESULTS: In this interval, 535 AVG were inserted in 427 patients. Ten patients presented with a seroma and underwent surgical treatment. Overall incidence of seroma formation was 1.7%. There was no significant difference in seroma formation based on gender, age, diabetes, lower extremity versus upper extremity placement, or loop forearm versus straight forearm grafts. A statistically significant difference was found between upper arm (p = 0.007) and lower arm grafts (p = 0.04), with upper arm grafts more prone to seroma formation. Patients undergoing bypass of the seromatous segment of graft have not had a recurrence, compared with those who were simply evacuated and have had a mean patency of 402 days. CONCLUSIONS: Seroma complications after AVG insertion are higher in patients with upper arm grafts. To minimize this complication, meticulous operative technique is required. If a seroma develops, the graft might still be salvageable with aggressive management, including bypass of the involved segment.