Multicenter double-blinded randomized controlled trial of standard abdominal wound edge protection with surgical dressings versus coverage with a sterile circular polyethylene drape for prevention of surgical site infections A CHIR-net trial (BaFO; NCT01181206)
Mihaljevic A.L.,TU Munich |
Schirren R.,TU Munich |
Ozer M.,TU Munich |
Ottl S.,TU Munich |
And 35 more authors.
Annals of Surgery | Year: 2014
Objective: To determine whether circular plastic wound edge protectors (CWEPs) significantly reduce the rate of surgical site infections (SSIs) in comparison to standard surgical towels in patients undergoing laparotomy. Background: SSIs cause substantial morbidity, prolonged hospitalization, and costs and remain one of themost frequent surgical complications. CWEPs have been proposed as a measure to reduce the incidence of SSIs. Methods: In this randomized controlled, multicenter, 2-arm, parallel-group design, patient- And observer-blinded trial patients undergoing open elective abdominal surgery were assigned to either intraoperative wound coverage with a CWEP or standard coverage with surgical towels. Primary endpoint was superiority of intervention over control in terms of the incidence of SSIs within a 30-day postoperative period. Results: Between September 2010 and November 2012, 608 patients undergoing laparotomy were randomized at 16 centers across Germany. Three patients in the device group and 11 patients in the control group did not undergo laparotomy. Patients' and procedural characteristics were well balanced between the 2 groups. Forty-eight patients discontinued the study prematurely, mainly because of relaparotomy (control, n = 9; intervention, n = 9) and death (control, n = 4; intervention, n = 7). A total of 79 patients experienced SSIs within 30 days of surgery, 27 of 274 (9.9%) in the device group and 52 of 272 (19.1%) in the control group (odds ratio = 0.462, 95% confidence interval: 0.281-0.762; P = 0.002). Subgroup analyses indicate that the effect could be more pronounced in colorectal surgery, and in cleancontaminated/ contaminated surgeries. Our trial shows that CWEPs are effective at reducing the incidence of SSIs in elective and clean or clean-contaminated open abdominal surgery. Copyright © 2014 by Lippincott Williams & Wilkins.
Cotofana S.,Kreisklinik Altotting |
Cotofana S.,Paracelsus Medical University |
Tillman B.,University of Kiel |
Pufe T.,RWTH Aachen |
And 7 more authors.
Annals of Anatomy | Year: 2012
Purpose: To present an explicatory pathophysiological model for the rare clinical case of a total proximal hamstring rupture for the first time in the literature. Methods: A non-athletic healthy female (49 years) experienced a complete rupture of the right conjoint tendon of the biceps femoris (long head) and semitendinosus muscle while slipping down a lawn-covered slope (eccentric hip flexion and knee extension during stance phase of gait after heel-strike). A hamstring rupture was diagnosed by clinical examination and confirmed by magnet resonance imaging (MRI). Surgical reattachment of the conjoint tendon to the ischial tuberosity was performed. One year after surgery, she experienced no pain or functional impairment. Results: Histological analysis and immune-histochemical staining (vascular endothelial growth factor - receptor 2) of a biopsy taken intra-operatively revealed signs of fibroblast proliferation and vasculoneogenesis with absence of inflammatory changes indicating that repairing mechanisms and tissue remodeling had been taking place. Conclusion: This case report provides evidence for the hypothesis that micro-injuries induce repairing mechanisms and thus tissue remodeling which leads to consecutive tissue weakening and mechanical failure during a non-adequate trauma. Micro-injuries can occur during leisure activities and remain clinically invisible until rupture. © 2012 Elsevier GmbH.