Reduction Of Surgical Site Infection using a Novel Intervention

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ROSSINI ? Background. Surgical site infection (SSI) post-laparotomy Up to 15% of clean-contaminated surgery30-40% of ?dirty' operations? of post-operative deaths Additional cost ? up to ?6KWound-edge Protectors - not mentioned in NICE guidelines but 2 previous small RCTs showing favourable ou

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Reduction Of Surgical Site Infection using a Novel Intervention

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1. Reduction Of Surgical Site Infection using a Novel Intervention

2. ROSSINI – Background Surgical site infection (SSI) post-laparotomy Up to 15% of clean-contaminated surgery 30-40% of ‘dirty’ operations ? of post-operative deaths Additional cost – up to Ł6K Wound-edge Protectors - not mentioned in NICE guidelines but 2 previous small RCTs showing favourable outcome

3. ROSSINI – Design West Midlands Research Collaborative Successful NIHR RfPB grant application for Ł250,000 Full time trials manager based at Birmingham Primary Care Trials Unit IRAS ethical approval granted 750 patients over 2 years at 22 sites

4. Primary Hypothesis: Use of a wound-edge protection device in adults undergoing laparotomy will result in a reduced rate of surgical site infection (SSI) at 30 days.

5. Secondary Objectives: To determine whether the efficacy of a wound-edge protection device in reducing SSI is associated with: 1) The degree of wound contamination (clean / clean / contaminated / contaminated / dirty) 2) Comorbidity (e.g. diabetes, smoking, obesity) 3) Duration of operation 4) Grade of surgeon closing wound And to assess if the use of a wound-edge protection device: 5) Improves health-related quality of life (QoL) 6) Reduces length of stay in hospital 7) Is cost-effective and safe

6. Is the patient eligible? Inclusion criteria Over 18 Laparotomy via midline, transverse or Kocher’s/Rooftop Any surgical indication Emergency and Elective cases Exclusion criteria Unable to consent Laparoscopic assisted cases

8. Follow-up plans Definition of SSI Using the internationally accepted ‘Centers for Disease Control’ guidelines Blinded wound reviews performed at 1) Day 5-7 2) Day 30-33 Using standardised wound assessment tool:

9. Talk about pilot studyTalk about pilot study

10. ROSSINI – Opening a Site

11. Rossini Site Team Principle investigator - One Consultant 2x Registrars Research / Specialist Nurses All researchers will require Good Clinical Practice (GCP) training prior to consenting participants

12. Website www.rossini.bham.ac.uk - Full study protocol - Link to randomiser - Instruction for surgeons - All 6 Case Report Form samples - Letter to GP, consent form etc

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