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Pilot Study for a randomised trial comparing the influence of forced air versus resistive fabric warming technologies on post-operative infection rates following orthopaedic implant surgery in adults

 

Trial Status:             Pilot Study Complete; Awaiting Full Trial

RESEARCH SUMMARY

Hip fractures following a fall are common in older people because they often have weakened or brittle bones. In most cases, surgery is the only treatment option. There are currently about 70,000 operations per year in the UK to repair hip fractures with around 2.5% of cases developing serious infections after the surgery .

Deep surgical site infections can lead to the need for further surgery, problems with recovery and long-term treatment with antibiotics which is neither good for the patient nor for the health economy and overuse of antibiotics is encouraging the emergence of antibiotic resistance.

The risk of developing a surgical site infection is reduced by preventing the patient from becoming too cold (hypothermic) during the surgery. Different methods of keeping patients warm are used in different hospitals. The method used most often is called Forced Air Warming. It keeps patients warm with hot air (a bit like a hair dryer) but there are concerns that blowing hot air in the operating theatre may alter the sterile environment during surgery. An alternative method used in some hospitals is called Resistive Fabric Warming. It is more like an electric blanket and can keep patients warm without blowing hot air in the operating theatre.

In the long-term, the aim of this study is to compare these two warming technologies to see if fewer surgical site infections develop with one method than the other. We conducted a pilot study first to check that we would be able to recruit enough participants for a full clinical trial.

The pilot study demonstrated robust recruitment and data management strategies and that both Forced Air Warming and Resistive Fabric Warming are safe to use and effective at maintaining normothermia. Surgical site infections were observed in both groups. No statistical comparisons of infection can be made from the pilot study.

Funding is now sought to conduct an adequately powered full trial.

Number of Participants Recruited:                515 (pilot study)

Number of Recruitment Centres:  (pilot study)

Trial Registration:  

ISRCTN74612906 (Pilot)

Funding Sources:  3MTM (Patient Warming Solutions); Healthcare Infection Society;  University of Oxford

Main contact for this trial:

 Michelle.Kumin@ndm.ox.ac.uk

Publications:

Reducing Implant Infection in Orthopaedics (RIIiO): Results of a pilot study comparing the influence of forced air and resistive fabric warming technologies on postoperative infections following orthopaedic implant surgery. Kümin M et alJ Hosp Infect. (2019) 103: p.412-419.

 

 

Reducing Implant Infection in Orthopaedics (RIIiO): a pilot study for a randomised controlled trial comparing the influence of forced air versus resistive fabric warming technologies on postoperative infection rates following orthopaedic implant surgery in adults. Kümin M et al. Trials. (2018) 19;19(1):640

 

Laminar flow ventilation during surgery. Kümin M, Scarborough M. Lancet Infect Dis. (2017) 17(6):581