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- Rezk, Francis, et al.
(författare)
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Incisional negative pressure wound therapy for the prevention of surgical site infection after open lower limb revascularization – Rationale and design of a multi-center randomized controlled trial
- 2019
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Ingår i: Contemporary Clinical Trials Communications. - : Elsevier BV. - 2451-8654. ; 16
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Lower limb revascularization with inguinal incisions is a common vascular surgical procedure. Due to risk of injury to lymphatic vessels and a diverse bacterial flora in the groin, surgical site infections (SSI) represent a common and sometimes life-threatening complication. While transverse incisions in endovascular aneurysm repair has a low SSI rate, vertical incisions in thrombendarterectomy (TEA) has a higher risk and bypass the highest risk. This randomized controlled trial (RCT) will investigate the protective role of negative pressure wound therapy (NPWT) on closed inguinal incisions in elective vascular surgery undergoing TEA and bypass procedures, respectively, to prevent SSI. Methods: This RCT registered at ClinicalTrials.gov (Identifier: NCT01913132) compares the effects of a NPWT dressing (PICO™, Smith & Nephew, UK) to standard wound dressing on postoperative SSI. The multi-center study includes two distinct vascular procedures with different SSI risk profiles: TEA and lower limb bypass. Three hundred and fifty-eight groin incisions are anticipated to be included in the TEA group and 133 inguinal incisions in the bypass group. Bilateral inguinal incisions will be randomized to NPWT in one groin and control dressing in the contralateral groin, and this dependency was accounted for in sample size calculation and will be addressed in data analysis. Discussion: This RCT attempts to evaluate the potential benefit of NPWT on closed inguinal incisions after two distinct vascular procedures at high risk of SSI. Outcome of this trial could have implications on postoperative wound care in both vascular and non-vascular surgical patients.
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- Taule, T., et al.
(författare)
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Edinburgh Cognitive and Behavioral Amyotrophic Lateral Sclerosis Screen (ECAS) in Norway: Protocol for validation and a prospective cohort study
- 2019
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Ingår i: Contemporary Clinical Trials Communications. - : Elsevier BV. - 2451-8654. ; 14
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Tidskriftsartikel (refereegranskat)abstract
- In amyotrophic lateral sclerosis (ALS) cognitive impairment may occur. This could detrimentally influence communication between patient and health-care professionals and make clinical assessment difficult. Given the short life expectancy after diagnosis, it is crucial to accurately identify ALS patients early. Although suitable cognitive screening tools for patients with ALS are available, they have not been evaluated in a Norwegian population. Interpretation of scores for available tests and practical application of scoring is also not well established. The protocol described here involves two related studies that aim to improve the quality of ALS clinical testing instruments used in the Norwegian population. The first is a validation study that evaluates the psychometric properties of the ECAS-Norwegian. The second is a prospective cohort study that evaluates the ECAS-Norwegian as a tool to predict early changes in ability to work, drive a car and the need for advanced therapy. Study 1 is a multicenter study using international quality criteria. Patients with ALS, healthy control subjects, and control subjects with dementia will be included. Primary outcome is ECAS-Norwegian scores. In study 2, patients with ALS will be included. ECAS-Norwegian compared to Clinical Dementia Rating score and Montreal Cognitive Assessment scores will be used as a prognostic tool for working, driving, and initiating advanced life-prolonging therapy. Before clinical implementation, the ECAS-Norwegian needs to be evaluated and validated. Successful validation and implementation of the ECAS-Norwegian may provide early identification of cognitive impairment in ALS, leading to more proactive, individualized treatment.
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