Patient reported cosmetic outcome after vacuum assisted excision of benign breast lesions:a cross-sectional study

OBJECTIVE: Better cosmetic outcome after vacuum assisted excision (VAE) compared to surgical excision of benign breast lesions is suggested in previous studies but has never been evaluated with validated outcome measures. In this study, patient reported cosmetic outcome after VAE was evaluated. METHODS: Patients who underwent VAE between July 2017 and December 2018 were invited to complete the cosmetic subscale of the Dutch Breast Cancer Treatment Outcome Scale, comparing the treated with the untreated breast. Response mode ranged from 1 (no difference) to 4 (large difference) and cosmetic outcome was calculated as the unweighted mean. Clinical outcomes included: tumor size, number of cores, complications, residual lesions and recurrences. RESULTS: Response rate was 73.4% (47 of 64 patients). Median tumor size was 15 mm (range 5-51 mm) and median number of cores 6.5 (range 1-85), complete excision was confirmed in all but two patients. Mean cosmetic outcome was good (mean score ≤1.75) in 74% of patients and no patients reported a poor cosmetic outcome (mean score >3.25). A hematoma occurred in five patients (one needed aspiration) and a skin rash in one patient, no patients developed an infection or seroma. CONCLUSION: In this study VAE is safe and effective for tumors up to 5 cm and patient reported cosmetic outcome was good. Patients with benign lesions could benefit from VAE as an alternative for surgical excision. ADVANCES IN KNOWLEDGE: A formal quantitative measurement of cosmetic outcome after vacuum assisted excision for benign breast lesions was still lacking. This study shows that this cosmetic outcome is overall good in benign lesions up to 5 cm

Randomized controlled trial comparing magnetic marker localization (MaMaLoc) with wire-guided localization in the treatment of early-stage breast cancer

Wire-guided localization (WGL) is the standard of care in the surgical treatment of nonpalpable breast tumors. In this study, we compare the use of a new magnetic marker localization (MaMaLoc) technique to WGL in the treatment of early-stage breast cancer patients. Open-label, single-center, randomized controlled trial comparing MaMaLoc (intervention) to WGL (control) in women with early-stage breast cancer. Primary outcome was surgical usability measured using the System Usability Scale (SUS, 0-100 score). Secondary outcomes were patient reported, clinical, and pathological outcomes such as retrieval rate, operative time, resected specimen weight, margin status, and reoperation rate. Thirty-two patients were analyzed in the MaMaLoc group and 35 in the WGL group. Patient and tumor characteristics were comparable between groups. No in situ complications occurred. Retrieval rate was 100% in both groups. Surgical usability was higher for MaMaLoc: 70.2 ± 8.9 vs. 58.1 ± 9.1, p < 0.001. Patients reported higher overall satisfaction with MaMaLoc (median score 5/5) versus WGL (score 4/5), p < 0.001. The use of magnetic marker localization (MaMaLoc) for early-stage breast cancer is effective and has higher surgical usability than standard WGL

Treatment of early-stage breast cancer with percutaneous thermal ablation, an open-label randomised phase 2 screening trial:rationale and design of the THERMAC trial

INTRODUCTION: Breast cancer is the most frequently diagnosed malignancy worldwide but almost half of the patients have an excellent prognosis with a 5-year survival rate of 98%–99%. These patients could potentially be treated with thermal ablation to avoid surgical excision, reduce treatment-related morbidity and increase patients’ quality of life without jeopardising treatment effectiveness. Previous studies showed highest complete ablation rates for radiofrequency, microwave and cryoablation. However, due to heterogeneity among studies, it is unknown which of these three techniques should be selected for a phase 3 comparative study. METHODS AND ANALYSIS: The aim of this phase 2 screening trial is to determine the efficacy rate of radiofrequency, microwave and cryoablation with the intention to select one treatment for further testing in a phase 3 trial. Additionally, exploratory data are obtained for the phase 3 trial. The design is a multicentre open-label randomised phase 2 screening trial. Patients with unifocal, invasive breast cancer with a maximum diameter of 2 cm without lymph node or distant metastases are included. Triple negative, Bloom-Richardson grade 3 tumours and patients with an indication for neoadjuvant chemotherapy will be excluded. Included patients will be allocated to receive one of the three thermal ablation techniques. Three months later surgical excision will be performed to determine the efficacy of thermal ablation. Treatment efficacy in terms of complete ablation rate will be assessed with CK 8/18 and H&E staining. Secondary outcomes include feasibility of the techniques in an outpatient setting, accuracy of MRI for complete ablation, patient satisfaction, adverse events, side effects, cosmetic outcome, system usability and immune response. ETHICS AND DISSEMINATION: This study protocol was approved by Medical Research Ethics Committee of the Erasmus Medical Center, Rotterdam, the Netherlands. Study results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NL9205 (www.trialregister.nl); Pre-results

Vuurwerkletsel in Zuidwest-Nederland rond de jaarwisseling 2017-2018

OBJECTIVE: To report the number of patients with firework-related injuries treated in December 2017 and January 2018 in a hospital in the south-west Netherlands trauma region, and to provide details about the types of firework used and the specific injuries. DESIGN: A prospective multicentre cohort study (NTR6793). METHODS: Patients of all ages with firework-related injuries were eligible for inclusion. The injury had to have been sustained between 1 December 2017 and 31 January 2018, and treated at a hospital in the south-west Netherlands trauma region (approximately 2.5 million inhabitants). Data were extracted from patients' medical files and additional information was obtained from patient interviews. RESULTS: Fifty-four patients were included. The majority were male (93%) and the median age was 15 years. Twenty-five (46%) patients were bystanders and 12 (22%) were injured by illegal fireworks. Fifty patients were injured by bangers (n=22) or decorative fireworks (n=28). The patients had a total of 79 injuries, of which 29 (37%) were localised to the upper extremity and 19 (24%) to the eyes. Most upper extremity injuries were burns (69%), primarily partial thickness. Of the eye injuries, 14 were caused by blunt trauma, seven by chemical trauma, and one by penetrating trauma. Three patients sustained indirect firework-related injuries. CONCLUSION: Between 1 December 2017 and 31 January 2018 in the south-west Netherlands trauma region mainly teenage males and bystanders sustained firework-related injuries. Most injuries were upper extremity burns and eye injuries, mainly due to legal fireworks and bangers or decorative fireworks. The extent of the sample indicatDoel Een volledig overzicht geven van het aantal vuurwerkslachtoffers dat in december 2017 en januari 2018 behandeld werd in een ziekenhuis in de traumaregio Zuidwest-Nederland, het gebruikte soort vuurwerk en de specifieke letsels. Opzet Een prospectieve, multicentrische cohortstudie (NTR6793). Methode Patiënten van alle leeftijden met vuurwerkletsel kwamen in aanmerking voor inclusie. Het letsel moest zijn ontstaan in de periode 1 december 2017-31 januari 2018 en zijn behandeld in een ziekenhuis in de traumaregio Zuidwest-Nederland (circa 2,5 miljoen inwoners). Gegevens werden verzameld vanuit het patiëntendossier en aanvullende gegevens werden verkregen tijdens een interview. Resultaten Er werden 54 patiënten geïncludeerd. Het overgrote deel betrof mannen (93%) en de mediane leeftijd was 15 jaar. 25 gewonden (46%) waren omstander en 12 mensen (22%) raakten gewond door illegaal vuurwerk. Van de 54 patiënten raakten er 50 gewond door knalvuurwerk (n = 22) of siervuurwerk (n = 28). De 54 geïncludeerde patiënten hadden 79 letsels; het letsel was 29 keer (37%) gelokaliseerd aan armen of handen en 19 keer (24%) aan de ogen. Letsel aan de arm of hand bestond voornamelijk uit brandwonden (69%), met name tweedegraads. Oogletsel werd 14 keer door stomp inwerkend geweld veroorzaakt, 7 keer door chemisch letsel en 1 keer werd het oog gepenetreerd. Er raakten 3 patiënten indirect gewond door vuurwerk. Conclusie In de traumaregio Zuidwest-Nederland raakten in de 2 maanden rond de jaarwisseling 2017-2018 vooral minderjarige mannen en omstanders gewond. Slachtoffers liepen met name brandwonden aan armen of handen of oogletsel op. De verwondingen waren met name het gevolg van legaal knal- en siervuurwerk. Door de omvang van de steekproef lijken de studiebevindingen goed te extrapoleren naar het gehele land

A randomized controlled trial on the effect of a silver carboxymethylcellulose dressing on surgical site infections after breast cancer surgery

<div><p>Background</p><p>The incidence of surgical site infections (SSIs) after breast cancer surgery is relatively high; ranging from 3 to 19%. The role of wound dressings in the prevention of SSI after breast cancer surgery is unclear. This study compares a silver carboxymethylcellulose dressing (AQUACEL Ag Surgical (Aquacel) with standard wound dressing in SSI rate after breast cancer surgery.</p><p>Patients and methods</p><p>A single-centre randomized controlled trial among women ≥18 years, diagnosed with breast cancer, undergoing breast conserving or ablative surgery, was conducted in a combined in and outpatient setting. The intervention was the use of Aquacel, compared with standard gauze dressing. Primary outcome measure was SSI following CDC criteria.</p><p>Results</p><p>A total of 230 patients were analysed: 106 in the Aquacel group and 124 controls. Seven patients (6.6%) developed SSI in the Aquacel group and 16 patients (12.9%) in the control group (RR 0.51 [95% Confidence Interval (CI): 0.22–1.20]; p = 0.112; adjusted OR 0.49 [0.19–1.25] p = 0.135)). Unplanned exploratory subgroup analysis of breast conserving surgery patients showed that SSI rate was 1/56 (1.8%) in the Aquacel group vs. 7/65 (10.8%) in controls; adjusted OR 0.15 [0.02–1.31] p = 0.087. The Aquacel group showed better patient satisfaction (median 8 vs. 7 on a Numerical Rating Scale, p = 0.006), fewer dressing changes within 48 hours(adjusted OR 0.12 [0.05–0.27] p<0.001), fewer re-operations (0% vs. 3.2%, p = 0.062), and lower mean wound-related treatment costs, both in a high (€265.42 (SD = 908) vs. €470.65 (SD = 1223) [p<0.001]) and low (€59.12 (SD = 129) vs. €67.55 (SD = 172) [p<0.001]) attributable costs of SSI model.</p><p>Conclusion</p><p>In this randomized controlled trial in women undergoing surgery for breast cancer, the use of AQUACEL Ag Surgical wound dressing did not significantly reduce the occurrence of SSIs compared to standard gauze dressing. The use of Aquacel resulted in significantly improved patient satisfaction, reduced dressing changes and reduced wound-related costs.</p><p>Trial registration</p><p><a href="http://www.trialregister.nl" target="_blank">www.trialregister.nl</a>: <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5840" target="_blank">NTR5840</a></p></div

Prospective cohort protocol examining the perioperative indicators for complications and early mortality following hip fracture surgery in the frail patient

Introduction The primary aim is to validate earlier suggested risk factors and to find new associated risk factors for (30-day) mortality after a hip fracture in the frail population. The secondary aim is to determine the factors associated with perioperative complications. At last we want to develop and validate a more specific 30-day mortality prediction tool compared with the Nottingham Hip Fracture Score. The 30-day mortality prediction can help inform surgical risk and guide shared decision-making among patients, family and physicians.Methods and analysis The study is designed as a prospective multicentre cohort study within the area of Rotterdam, the Netherlands starting from January 2018. All patients over 65 years of age, with an acute proximal hip fracture, are included. Treatment of patients will be by standard practice of care using the latest national and international guidelines. Inclusion will be continued at least until January 2021 and including at least 2500 patients. In this large cohort we hope to have sufficient strength and quality to identify risk factors of 30-day mortality and to compare them to known risk factors in literature. Moreover, we plan to develop and validate a 30-day mortality prediction tool, which identifies patients with a high probability of 30-day mortality.Ethics and dissemination Ethical approval for this protocol was given by the Ethics Committee of the Maasstad Hospital (TWOR). Patient data are stored anonymously using the Castor data management system. No external funding is used for this study. Results will be published in peer-reviewed publications and at international conferences.Trial registration number NL8313

Microbiological culture results of SSI cases.

<p>Microbiological culture results of SSI cases.</p

Baseline characteristics.

<p>Baseline characteristics.</p

Outcome measures and comparison between the groups.

<p>Outcome measures and comparison between the groups.</p

CDC criteria for an SSI [14,22].

<p>^aDiagnosis of ‘cellulitis’ alone does not meet criterion 4 since 2010, but this change underestimates the infection rate and is not recommended to be used by Degnim [<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0195715#pone.0195715.ref005" target="_blank">5</a>].</p