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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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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 6K
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 250,000
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 Kochers/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