Minutes of Monthly Meeting

Minutes of Monthly Meeting

Monday, 2ndSeptember2013

18:30

Venue: Seminar rooms, new QEHB

Attendees:

Ravi Vohra

Tom Pinkney

Abi Patel

Lara Bone

Caroline Taylor

PiyushSarmah

Suzanne Ellis

Zoe Gales

Rachel Barratt

Marianne Johnstone

Anne Gaunt

NaeilLotfi

John Hardman

Ed Rawstorne

Philip Spreadborough

Apologies:

Prof Morton

Andy Torrance

Kay Futaba

Paul Marriott

David Bartlett

1. ROSSINI II

A multi arm complex design trial is being proposed with three or four possible separate interventions that could potentially be changed or added to as the trial progresses.

Ongoing discussions with Prof Deeks and BCTU regarding design.Due to the number of interventions, such a study will need to recruit a large number of patients. At the moment, literature reviews of the four interventions are being conducted –

Gentamicin impregnated wound devices – Ed Rawstorne

Change of gloves – AneelBhangu

Incise drapes – Pritam Singh

2% vs 0.5% vs 0.05% Chlorhexidine – pending

Devicecompany that supported ROSSINI I are keen to support the trial.

2. Literature review presentation – Ed Rawstorne

ER presented literature review on using gentamicin-impregnated implants. Several studies have been conducted in orthopaedic/cardiothoracic surgery although there are some in abdominal surgery. Review of studies to date in general surgery shows possible marginal benefit but the largest and best-conducted RCT published in NEJM (Bennett-Guerroro) showed a higher infection rate in the intervention arm. This trial had an excellent design and follow-up regimen. The company that makes Collatemp suggested this may have occurred as the sponge was soaked for too long therefore gentamicin was washed out. Despite this, there is still scope to investigate this further, however, we may have some difficulty convincing ethics/funding bodies as they are unlikely to support a trial with an intervention which has been shown to cause harm.

Some discussion about how best to proceed further – it was decided that we could audit current practice in a few of the hospitals to see what is being done. ER to lead and liaise with CTs that have expressed an interest and report back to next meeting.A survey of ROSSINI collaborators could also be performed to determine which of these interventions surgeons are most likely to want to perform if they come into the trial.

3. SEPSIS audit (Led by SPARCS)

7 centres from West Midlands so far. Further email to be sent by AP to mailing list to advertise it further.

4. Ongoing projects

DREAMS – more than 1000 patients recruited. Need to formalise handover for October changeover to ensure there is no reduction in patient recruitment.

ROCCS – 77/90 patients for phase II have been recruited. New centres opening including Leicester and Amsterdam. RfPB funding or needs HTA funding (BCTU to decide).

ASLAN – Stoke recruited 50 patients. QE/Wolverhampton recruited around 30 patients. Target is 150 patients. CT aortic calcification is running in parallel.

WPBA study – quantitative data completed except Scotland. 18 centres have participated with more than 100 trainees and trainers. 80 per cent response rate.

P-POP – awaiting decision from RfPB funding application

CholeS study – protocol almost finalised. Data collection tool being devised. 5 centres to run pilot in November with main study in February. May be endorsed by AUGIS.

5. Any other business

BLUEBELLE study – HTA grant has been granted for a qualitative feasibility study addressing the views of surgeons, nurses and patients on using different wound dressings (or using no dressing at all). Study is funded for trainees to learn how to conduct qualitative research with training opportunities provided by the trials unit. First meeting is planned for October. All those interested to contact Tom Pinkney or Andy Torrance.

Next meeting – 7thOct 2013, seminar room TBC, new QEHB.