Information for Investigators

 This page contains all the information required by participating investigators: 

Link to the randomisation website...

Please go to https://www.pc-crtu.bham.ac.uk/rossini to access the ROSSINI randomisation website.

Please note this site will require a username and password. If you do not have these please contact the trials office.

 

Guidelines for Surgeons...

The Guidelines for Surgeons sheet provides guidelines on changes to the normal operative procedure for patients entered into the trial.

 

Trial Documentation...

Trial Protocol

The latest version of the full ROSSINI trial protocol:

ROSSINI Protocol Version 4; 14th March 2011

Data Collection Forms

Case Report Form 1 - Demographic Data and Preoperative Assessment

Case Report Form 2 - Operative Data

Case Report Form 3 - First Wound Review - Day 5-7 Post-op

Case Report Form 4 - Wound Healing Post-discharge Questionnaire

Case Report Form 4a - Wound Healing Diary

Case Report Form 5 - Final Wound Review - Day 30-33 Post-op

Case Report Form 6 - Resource Utilisation - (up to 30 days)

Case Report Form 6a - Hospital Care Following 30 day Assessment

Wound Dressing Diary - Wound Dressing Diary (for hospital and home)

EuroQOL (EQ-5D) - Quality of life questionnaire 

Patient information, consent form and GP letter

These documents must be printed on Trust headed paper if they are to be used in the trial

Patient information sheet

Consent form

GP letter

 

Information on how to open a new site...

The Rossini team are interested to hear from sites wishing to participate in the trial. If your centre would like to participate, please read through the information below and contact the trials office.

Each site will need to identify a Principal Investigator who will be a consultant surgeon. Their role will include a number of responsibilities:

  • day-to-day responsibility for the conduct of the research
  • ensuring the protocol is followed correctly
  • ensuring participants receive appropriate care during their involvement in research
  • maintaining the integrity and confidentiality of records
  • reporting adverse events.

Participating sites may also identify additional researchers (likely to be surgical consultants or registrars) who will be involved in the recruitment and follow up of patients during the trial. All clinicians involved in recruiting and consenting patients for trial must have completed the Good Clinical Practice Course. Most trusts will be able to provide this free of charge. Alternatively the course can be completed online via the GCP website for a moderate fee.

All research sites will require local R&D approval as well as approval by the Trust Management before any patients can be recruited. The ROSSINI trials office will assist with these processes and complete much of the other paperwork required.

In order for us to begin the process of adding your site, please contact Jenni Bradbury at the trials office with the name and CV of the Principal Investigator.

 

Contact...

For help with opening a new site, obtaining access to the randomisation website or any other queries about the day-to-day running of the trial please contact the trials office at:

ROSSINI Study Office,
University Hospital Birmingham NHS Trust
Queen Elizabeth Medical Centre
Birmingham, B15 2TH

email: j.m.bradbury@bham.ac.uk

tel: 0121 627 2283

For any other information or queries regarding ROSSINI please contact Tom Pinkney (thomas.pinkney@tiscali.co.uk) or Dave Bartlett (david_bartlett2@hotmail.com)