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Surgical site infections (SSI) in vascular surgery have a huge impact on patients’ morbidity and mortality and healthcare systems worldwide. Dialkylcarbamoylchoride (DACC) is a synthetically produced material that can irreversibly bind and inactivate bacteria that exhibit cell-surface hydrophobicity (CSH). The DACC in the Reduction of Surgical Site Infection (DRESSINg) trial is a multicentre randomised controlled trial which aims to assess the effectiveness of DACC-coated post-operative dressings in the prevention of SSI in vascular surgery. Seven hundred and eighteen participants undergoing clean or clean-contaminated lower limb vascular surgery will be randomised in a 1:1 ratio to either DACC-coated dressings or standard dressings for their postoperative wounds. The primary outcome is the incidence of SSI defined by the Centers for Disease Control and Prevention (CDC) criteria or total ASEPSIS score of 21 or more within 30 days of surgery. The secondary outcomes include satisfactory wound healing with a total ASEPSIS score of 10 or less, quality of life pre and post surgery, Bluebelle wound healing scores, resource use and financial (£), and environmental (KgCO2e) cost analyses. This multicentre randomised controlled trial will provide level 1 evidence on the effectiveness of preventing SSI in lower limb vascular surgery.
There is an urgent need for effective interventions to aid diabetes-related foot ulcer (DFU) healing. This study aimed to test the deliverability of a proposed trial of extracorporeal shockwave therapy (ESWT) for DFU healing. A pilot double-blinded randomised controlled trial. Patients with a DFU present for ≥ 4 weeks were randomised to high dose (500 shocks/cm2), low dose (100 shocks/cm2) or sham (0 shocks/cm2) ESWT, plus standard care. Follow-up was for 24 weeks. Primary outcome was deliverability of the trial. Secondary outcomes were healing, quality of life and healthcare resource use. One-hundred and forty-one (15.6%) screened patients were eligible and 74 (52.5%) patients were recruited. Follow-up attendance was 97.3% (72/74), 93.2% (69/74) and 87.8% (65/74) at 6, 12 and 24 weeks. The median DFU healing time was high dose: 54.0 (IQR 119.0), low dose: 78.5 (IQR 61.0) and sham: 83.0 (IQR 85.0) days. The mean EQ-5D-5L utility value at 24 weeks was high dose: 0.621 (95% CI 0.438–0.804), low dose: 0.779 (95% CI 0.683–0.876) and sham: 0.806 (95% CI 0.717–0.895). Healthcare resource use was lowest in the low-dose ESWT arm. The pilot trial has demonstrated that patients with a DFU are willing to engage in the proposed trial and suggest the optimal way to deliver the definitive trial.
FreshRSS 