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The role of a tissue viability research nurse

The VenUS III ultrasound trial, run by York University, compares ultrasound therapy plus standard care to standard care alone for the treatment of leg ulcers. Erica Denton explains the role of the research nurse

Erica Denton
RGN PN Dip in Community Healthcare Dip in CHD Prevention
Practice Nurse Sherburn and Rillington Surgeries

Clinical Research Nurse
North Yorkshire and York PCT

I have been a practice nurse for 13 years and in December 2005 I applied for a job that I felt would complement this role - that of a clinical research nurse working with the tissue viability team in our local primary care trust (PCT). The post would require me to recruit patients for a NHS-sponsored trial into the effect of ultrasound on healing leg ulcers.
Over the years in my practice nurse role I have cared for many patients with leg ulcers, but I was not prepared for the array of wounds I would see as I recruited for this trial. Some have been decades old and some have been so large that I have been astounded how the patients are actually still walking about.

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Background to the trial
There is reasonably robust research about healing leg ulcers: for example, there is good evidence that graduated multilayer compression promotes healing.(1) Ulcers on the lower leg can have various causes including venous insufficiency, varicose veins, obesity, immobility or following a deep vein thrombosis.(2)
Treatment is very expensive for the NHS, in terms of both dressings and nursing time. Given that healing rates are slow, with a high recurrence rate, any treatment that can be shown to speed up the healing process will be of benefit to patients, as well as to the NHS. We know that graduated high compression bandaging increases the healing rate of leg ulcers, but unfortunately the trials undertaken so far have not shown for definite which system is best - multilayer bandaging or short-stretch bandaging.(3) As a practice nurse who sees numerous patients with leg ulcers I felt the VenUS III ultrasound trial, which targets hard-to-heal ulcers, was a worthwhile project with results that would be enormously beneficial to nurses who look after this group of patients.

About the trial
The VenUS III trial is a multicentred randomised controlled trial that is funded by the Department of Health through its Health Technology Assessment Programme.(4) It compares ultrasound therapy plus standard care to standard care alone to study whether ultrasound improves healing rates. As a research nurse, my role is to identify patients who fit the trial criteria, ie, have a venous leg ulcer that is small and old ( 6 months old) or young and large ( 5 cm2). These criteria were chosen because there is evidence that ulcers of this size are hard to heal and take well over six months to heal.5 Patients are randomised to receive either a weekly dose of ultrasound of 1 MHz for five to 10 minutes at 0.5 W/cm2, for 12 weeks plus their standard care or just standard care.6
Recruitment started in August 2005 and we are currently seeking a total of 336 patients. The main outcome of the trial is to discover whether using ultrasound improves the healing rate of venous leg ulcers. It will also measure treatment costs, health-related quality of life and recurrence rates.

The role of the research nurse
Although I was an experienced practice nurse and had been involved in other trials at a low level I had a steep learning curve. My first challenge was to understand what the trial was about and how I could encourage other nurses to take part. I attended an education day at the University of York, which included training on patient eligibility, how to recruit patients, delivering ultrasound treatment, standard mapping techniques, working out the wound area, trial documentation and data collection. This has helped me work more collaboratively with community nurses and taught me some necessary practical skills. The ultrasound machines are calibrated and monitored regularly to ensure that the output is maintained throughout the trial. This can be a logistical problem as the three machines need to be back at the local hospital for the engineer to service on the same day. At one point I had machines spread throughout the whole of the PCT. I had to organise their collection and return them without disrupting the patients' treatment.
The most time-consuming part of the trial has been finding eligible patients. I began by telephoning all the local surgeries to introduce myself to the practice and district nurses and ask them if they had received information on the trial from the university. I answered any questions they had about the trial and then screened their patients. If eligible, the patients were sent an information letter to read before I visited to recruit them. If not, a screening form was completed detailing the reason for their exclusion and sent to the university.
The main concern from community nurses was how much extra time the treatment would take to administer. Once they realised it would take no longer than a maximum of 10 minutes they were willing to help in the research. Patients have been more concerned with where the treatment was to take place, but once reassured that an extra journey was not needed they were also usually willing to take part.
It is important to recruit patients ethically. They need to understand that being in the trial does not mean that they will definitely get ultrasound. Although the patients have the right to withdraw at any point, it is not ethical to recruit them if they state that they will withdraw if they don't get ultrasound treatment. Many of the identified patients have had their leg ulcers for a long time and to ensure that they are not given false hope that this new treatment will cure their ulcer, I discuss the trial fully with them and their nurse. Patients need to understand that we really have no idea if the treatment works or not. This can be very challenging in terms of communication, particularly since many patients are elderly and have hearing difficulties.
The application of the ultrasound treatment in practice has been straightforward and well tolerated by patients. Delivering the treatment to ulcers over 10 cm2 has needed careful planning as they need the maximum 10 minutes of ultrasound. This is a long time to be on your knees, bending over a patient's leg and therefore a couch or bed, at a suitable height, needs to be used to prevent back problems for the nurse. This is not always possible in a patient's home.
One important aspect of being a research nurse is having the clinical knowledge to be able to feed useful clinical information back to the research team. For example, the gel first issued with the ultrasound machines was very thin and slipped off the patient's leg easily, which made the total time of delivering the ultrasound longer than 10 minutes, due to contact problems. Both district and practice nurses' time is precious and after reporting back to the trial manager a different gel was provided, which has reduced the time spent administering the ultrasound. This practical, clinical feedback from trial nurses is vital for the university researchers. The mapping of the ulcers can take quite a long time as well, especially if the district or practice nurse is not experienced in tracing wounds or if the ulcers are particularly large, so once a month I offer to complete this for them, along with the digital photograph. This gives the patient continuity and face-to-face contact with someone from the trial team, rather than just filling in the three-monthly written postal questionnaires. I can also observe how their leg ulcer is progressing and observe the different dressing techniques.
The patients have not been averse to the photographing and tracing of their ulcers, in fact most have enjoyed the extra attention.
The recruitment is taking longer than anticipated and my contract has already been extended twice. This has been a dilemma as I have other commitments as a practice nurse. Having had so much involvement in the trial so far, I feel I would like to be part of it right through to completion, especially as the outcome may have a significant impact on how I treat patients with leg ulcers.

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Conclusion
I have travelled a total of 4,900 miles and screened nearly 200 patients, recruiting 27 into the trial. With the recent merger of my PCT I now cover a total population of 775,000 and an area of some 3,200 square miles, so I have plenty more patients to screen! Being involved in this trial has made me more aware of the district nursing workload and how nurses favour certain dressings according to the success rate they have with them.
I have certainly been challenged balancing my two jobs and have found the research work quite isolating. I have had to be very flexible when seeing patients - some have been seen at home, some in late surgery appointments and some in leg ulcer clinics. My original thought of 7.5 hours on one day never materialised as my hours can be spread over three days. I have always had fantastic support from the tissue viability nursing team I work with and have also studied my level 3 tissue viability module while being involved in the trial. The university trial team is also very helpful if any queries arise.
I have witnessed the psychological and physical impact leg ulcers have on patients and their families and how desperate some people are for their wounds to heal.
We need high-quality evidence-based knowledge on which to base our care and, whatever the outcome of the trial, knowledge of the effect of ultrasound has to be a bonus for both patients and clinicians. I have thoroughly enjoyed my trips around the countryside and my research experience, and I await the outcomes of the trial with anticipation.

References

  1. Cullum N, Nelson EA, Fletcher AW, Sheldon TA. Compression for venous leg ulcers. Cochrane Database of Systematic Reviews 2001; Issue 2.
  2. Kirby M, Wilson S. Venous leg ulcers. Br J Primary Care Nurs 2005;2:219-21.
  3. Iglesias C, Nelson EA, Cullum NA, Torgerson DJ on behalf of the VenUS team. VenUS 1 trial: a randomised controlled trial of two types of bandage for treating venous leg ulcers. Health Technol Assess 2004;8:1-105.
  4. National Coordinating Centre for Health Technology Assessment. VenUS III - venous ulcer studies III: ultrasound for venous leg ulcers. Southampton: NCCHTA; 2006. Available from http://www.hta.nhsweb.nhs.uk/project/1451.asp
  5. Margolis DJ, Berlin JA, Strom BL. Which venous leg ulcers will heal with limb compression bandages? Am J Med 2000;109;15-9.
  6. Watson J, Nelson E. An exploration of the use of ultrasound in the treatment of chronic leg ulcers. J Wound Care 2006;15:39-41.


Resources   
Clinical Practice Guidelines. The nursing management of patients with venous leg ulcers. London: RCN; 2006.

Venous leg ulcer - not infected. Prodigy Quick Reference Guide. 2005.
W: www.prodigy.nhs.uk/qrg/venous_leg_ulcer_not_infected.pdf
 
Cochrane Library
W: www.thecochranelibrary.com

VenUS III Trial
W: www.venus3.co.uk