Recovery to normal vital functions and acid-base status after a severe trauma in Level I versus Level II Trauma Centres.

PURPOSE: In the Netherlands, approximately 70% of severely injured patients (ISS ≥ 16) are transported directly to a Level I trauma center. This study compared the time needed to return to normal vital parameters and normal acid-base status in severely injured patients and some in-hospital processes in Level I versus Level II trauma centers. METHODS: This retrospective cohort study included all adult severely injured patients or adult trauma patients admitted to the intensive care unit between 2015 and 2020 in a Dutch trauma region. The primary endpoint was time until normal vital parameters and acid-base status. Secondary endpoints were complication rate, hospital length of stay, emergency department length of stay, and time until a computed tomography (CT) scan. RESULTS: A total of 2345 patients were included. Patients admitted to a Level I trauma center had a significantly higher rate of normalization of vital parameters over time (HR 1.51). There was no significant difference in normalization rate of the acid-base status over time (HR 1.10). In Level I trauma centers, time spent at the emergency department and time until the CT scan was significantly shorter (respectively, ß - 38 min and ß - 77 min), and the complication rate was significantly lower (OR 0.35). CONCLUSION: Severely injured patients admitted to a Level I trauma center require less time to normalize their vital functions. Level I centers are better equipped, resulting in better in-hospital processes with shorter time at the emergency department and shorter time until a CT scan.

Development and validation of the Brabant Hip Fracture Score for 30-day and 1-year mortality.

BACKGROUND: Hip fractures in the elderly are associated with advanced comorbidities and high mortality rates. Mortality prediction models can support clinicians in tailoring treatment for medical decision making in frail elderly patients. The aim of this study was to develop and internally validate the Brabant Hip Fracture Score, for 30-day (BHFS-30) and 1-year mortality (BHFS-365) after hip fracture. MATERIAL AND METHODS: A cohort study was conducted in 2 hospitals on operatively treated patients of 65 years and older with a hip fracture. Manual backward multivariable logistic regression was used to select independent predictors of 30-day and 1-year mortality. Internal validation was performed using bootstrapping techniques. Model performance was assessed with: (1) discrimination via the area under the receiver operating characteristic curve (AUC); (2) explained variance via Nagelkerke's R2; (3) calibration via Hosmer-Lemeshow (H&L) test and calibration plots. RESULTS: Independent predictors of 30-day mortality were: age, gender, living in an institution, Hb, respiratory disease, diabetes and malignancy. In addition, cognitive frailty and renal insufficiency, were selected in the BHFS-365. Both models showed acceptable discrimination after internal validation (AUC = 0.71 and 0.75). The Hosmer-Lemeshow test indicated no lack of fit (p > 0.05). DISCUSSION: We demonstrated that the internally validated and easy to use BHFS in surgically treated elderly patients after a hip fracture showed acceptable discrimination and adequate calibration. In clinical practice a cutoff of BHFS-30 ⩾ 24 could identify frail elderly patients at high risk for early mortality and could support clinicians, patients and families in tailoring treatment for medical decision making.

Epidemiology of injuries, treatment (costs) and outcome in burn patients admitted to a hospital with or without dedicated burn centre (Burn-Pro): protocol for a multicentre prospective observational study.

INTRODUCTION: The Emergency Management of Severe Burns (EMSB) referral criteria have been implemented for optimal triaging of burn patients. Admission to a burn centre is indicated for patients with severe burns or with specific characteristics like older age or comorbidities. Patients not meeting these criteria can also be treated in a hospital without burn centre. Limited information is available about the organisation of care and referral of these patients. The aims of this study are to determine the burn injury characteristics, treatment (costs), quality of life and scar quality of burn patients admitted to a hospital without dedicated burn centre. These data will subsequently be compared with data from patients with<10% total bodysurface area (TBSA) burned who are admitted (or secondarily referred) to a burn centre. If admissions were in agreement with the EMSB, referral criteria will also be determined. METHODS AND ANALYSIS: In this multicentre, prospective, observational study (cohort study), the following two groups of patients will be followed: 1) all patients (no age limit) admitted with burn-related injuries to a hospital without a dedicated burn centre in the Southwest Netherlands or Brabant Trauma Region and 2) all patients (no age limit) with<10% TBSA burned who are primarily admitted (or secondarily referred) to the burn centre of Maasstad Hospital. Data on the burn injury characteristics (primary outcome), EMSB compliance, treatment, treatment costs and outcome will be collected from the patients' medical files. At 3 weeks and at 3, 6 and 12 months after trauma, patients will be asked to complete the quality of life questionnaire (EuroQoL-5D), and the patient-reported part of the Patient and Observer Scar Assessment Scale (POSAS). At those time visits, the coordinating investigator or research assistant will complete the observer-reported part of the POSAS. ETHICS AND DISSEMINATION: This study has been exempted by the medical research ethics committee Erasmus MC (Rotterdam, The Netherlands). Each participant will provide written consent to participate and remain encoded during the study. The results of the study are planned to be published in an international, peer-reviewed journal. TRIAL REGISTRATION NUMBER: NTR6565.

Should the Extended Lateral Approach Remain Part of Standard Treatment in Displaced Intra-articular Calcaneal Fractures?

The aim of this study was to evaluate the results of open reduction and internal fixation through the extended lateral approach (ELA) in displaced intra-articular calcaneal fractures and to determine whether this approach should remain part of standard therapy. This retrospective cohort study included 60 patients with 64 displaced intra-articular calcaneal fractures who underwent surgical treatment through the ELA. Outcome measures were the visual analog scale foot and ankle (VAS FA), the American Orthopedic Foot and Ankle Society (AOFAS) score, surgical site infections (SSIs), and reoperations. We determined the AOFAS score for 40 patients with 42 fractures, and 42 patients with 44 fractures completed the VAS FA questionnaire. The mean VAS FA score was 61.0 ± 23.4 and the median AOFAS score was 83 (range 33 to 100), with 55% good to excellent scores. We found 10.9% superficial SSIs successfully treated with antibiotics. In 4.7% of patients a deep SSI was diagnosed, wherefore premature implant removal was necessary. Patients with an SSI did not have significantly lower VAS FA or AOFAS scores than did patients without an SSI (p = .318 and p = .766, respectively). Implant removal in absence of SSIs was necessary in 17 patients because of pain, and 3 patients needed secondary arthrodesis because of persistent pain. We concluded that the ELA proved to be a safe procedure, and moreover the most common complications did not influence the long-term outcomes of patients. However, recent literature demonstrates that less invasive techniques seem to exceed the ELA with respect to wound complications.

Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial.

Importance: Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee. Objective: To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee. Design, Setting, and Participants: Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy. Interventions: A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). Main Outcomes and Measures: Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction. Results: Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, -1.7 [95% CI, -8.0 to 4.6], P = .60). Conclusions and Relevance: Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal. Trial Registration: clinicaltrials.gov Identifier: NCT02225821.

Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.

BACKGROUND: In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures. METHODS: This is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30 days and 6 months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Power = 80%, 2-sided alpha = 5%, including 15% lost to follow up). DISCUSSION: If administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of € 3.5 million per year. TRIAL REGISTRATION: This study is registered at Clinicaltrials.gov ( NCT02225821 ) and the Netherlands Trial Register ( NTR4393 ) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.

Lack of cell-cycle specific effects of tumor necrosis factor-alpha on tumor cells in vitro: implications for combination tumor therapy with doxorubicin.

Addition of tumor necrosis factor-alpha (TNF-alpha) to chemotherapy enhances tumor response in several treatment modalities. However, it has been shown that TNF-alpha, and several other cytokines, exert inhibitory effects on cell-cycle progression and by doing so may attenuate sensitivity of these cells to cell-cycle dependent cytotoxic drugs (e.g., doxorubicin). Here, we determined the cytotoxic effect of TNF-alpha on several tumor cell lines in vitro in combination with doxorubicin (cell-cycle dependent) or melphalan (cell-cycle independent), and its effect on cell-cycle progression. The rat cell lines were prepared from tumors, which were used previously in animal studies, in which synergy was shown between TNF-alpha and the cytotoxic drugs. Results demonstrate that the addition of TNF-alpha to doxorubicin or melphalan in vitro had no attenuating effect on the cytotoxic drugs. Depending on the cell type used, addition of TNF-alpha induced no or only an additive cytotoxic effect. Only the tested rat osteosarcoma tumor cells demonstrated a cell arrest in the G2 phase, which did not result in attenuation of the cytotoxicity of doxorubicin towards these cells.