Background: Elective implant removal (IR) after fracture fixation is one of the most common procedures within (orthopedic) trauma surgery. The rate of surgical site infections (SSIs) in this procedure is quite high, especially below the level of the knee. Antibiotic prophylaxis is not routinely prescribed, even though it has proved to lower SSI rates in other (orthopedic) trauma surgical procedures. The primary objective is to study the effectiveness of a single intravenous dose of 2 g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures. Methods: This is a multicenter, double-blind placebo controlled trial with a superiority design, including adult patients undergoing elective implant removal after fixation of a fracture of foot, ankle, lower leg or patella. Exclusion criteria are: an active infection, current antibiotic treatment, or a medical condition contraindicating prophylaxis with cefazolin including allergy. Patients are randomized to receive a single preoperative intravenous dose of either 2 g of cefazolin or a placebo (NaCl). The primary analysis will be an intention-to-treat comparison of the proportion of patients with a SSI at 90 days after IR in both groups. Discussion: If 2 g of prophylactic cefazolin proves to be both effective and cost-effective in preventing SSI, this would have implications for current guidelines. Combined with the high infection rate of IR which previous studies have shown, it would be sufficiently substantiated for guidelines to suggest protocolled use of prophylactic antibiotics in IR of foot, ankle, lower leg or patella. Trial registration Nederlands Trial Register (NTR): NL8284, registered on 9th of January 2020, https://www.trialregister.nl/trial/8284
Background: There is a lack of evidence regarding the relationship between family involvement and outcomes in gastrointestinal oncology patients after surgery. To evaluate the effect of a family involvement program for patients undergoing oncologic gastrointestinal surgery on unplanned readmissions within 30 days after surgery. Methods: A multicenter patient-preference cohort study compared 2 groups: patients who participated in the family involvement program versus usual care. The program comprised involvement of family caregivers in care and training of health care professionals in family-centered care. Multivariable regression analyses were used to evaluate the effect of the FIP on the number of unplanned readmissions up to 30 days after surgery. Secondary outcomes included complications sensitive to fundamental care activities, emergency department visits, intensive care unit admissions, hospital length of stay, and the need for professional home care after discharge. Results: Of the 301 patients included, 152 chose the family involvement program, and 149 chose usual care. Postoperative readmissions occurred in 25 (16.4%) patients in the family involvement program group, and 15 (10.1%) in the usual care group (P = .11). A significant reduction of 16.2% was observed in the need for professional home care after discharge in the family involvement program group (P < .01). No significant differences were found between the 2 groups in the other secondary outcomes. Conclusion: The family involvement program did not reduce the number of unplanned readmissions, but it led to a substantial reduction in-home care, which suggests an economic benefit from a societal perspective. Implementation of the family involvement program should, therefore, be considered in clinical practice.
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Introduction: There are two surgical approaches to reconstruct a pressure ulcer (PU): one-stage reconstruction or two-stage reconstruction. One stage reconstruction consists of surgical debridement and flap reconstruction during one operation. Two-stage surgery consist of a surgical debridement and a final reconstruction in two different sessions, with approximately six weeks between both sessions. Objective: The aim of this study was to compare the results of single stage surgery and two-stage surgery on the PU recurrence rate and other important post operative complications. Method: A retrospective, comparative study in Spinal Cord Injured (SCI) individuals with a single- or two stage surgical reconstruction between 2005 and 2016 was designed. A total of 81 records were included for analysis. Results: The primary outcome, the difference in occurrence of a recurrent PU in the reconstructed area (33.3% versus 31.6%), is not statistically significant between one-and two-stages reconstruction. Also, the mean duration to develop a recurrent PU between both surgical reconstructions is not statistically significant. Other surgical complications in the reconstructed area like wound hematoma, hemorrhage, seroma or (partial) flap failure did not differ significantly between both groups, apart and in total. We calculated the additional costs in case of a two-stage approach compared with a single-stage reconstruction at EUR 16,362. Conclusions: There are no statistical significant differences in PU recurrence rate or other post operative complications between SCI patients who have undergone one- or two stage PU reconstructive surgery. The most obvious choice for a one-stage approach in case of PU reconstructive surgery has great positive implications for the patient, family, health care providers and the health care system.
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