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: Hyperbaric oxygen therapy (HBOT) is used as a treatment for acute wounds (such as those arising from surgery and trauma). However, the effects of HBOT on wound healing are unclear. OBJECTIVES: To determine the effects of HBOT on the healing of acute surgical and traumatic wounds.SEARCH METHODS: We searched the Cochrane Wounds Group Specialised Register (searched 9 August 2013); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 12); Ovid MEDLINE (2010 to July Week 5 2013); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, August 08, 2013); Ovid EMBASE (2010 to 2013 Week 31); EBSCO CINAHL (2010 to 8 August 2013).SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing HBOT with other interventions such as dressings, steroids, or sham HOBT or comparisons between alternative HBOT regimens.DATA COLLECTION AND ANALYSIS: Two review authors conducted selection of trials, risk of bias assessment, data extraction and data synthesis independently. Any disagreements were referred to a third review author. MAIN RESULTS: Four trials involving 229 participants were included. The studies were clinically heterogeneous, which precluded a meta-analysis.One trial (48 participants with burn wounds undergoing split skin grafts) compared HBOT with usual care and reported a significantly higher complete graft survival associated with HBOT (95% healthy graft area risk ratio (RR) 3.50; 95% confidence interval (CI) 1.35 to 9.11). A second trial (10 participants in free flap surgery) reported no significant difference between graft survival (no data available). A third trial (36 participants with crush injuries) reported significantly more wounds healed (RR 1.70; 95% CI 1.11 to 2.61), and significantly less tissue necrosis (RR 0.13; 95% CI 0.02 to 0.90) with HBOT compared to sham HBOT. The fourth trial (135 people undergoing flap grafting) reported no significant differences in complete graft survival with HBOT compared with dexamethasone (RR 1.14; 95% CI 0.95 to 1.38) or heparin (RR 1.21; 95% CI 0.99 to 1.49).Many of the predefined secondary outcomes of the review were not reported. All four trials were at unclear or high risk of bias.AUTHORS' CONCLUSIONS: There is a lack of high quality, valid research evidence regarding the effects of HBOT on wound healing. Whilst two small trials suggested that HBOT may improve the outcomes of skin grafting and trauma, these trials were at risk of bias. Further evaluation by means of high quality RCTs is needed.
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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