BODYSTAT BIA STUDY

• Research type

  Research Study

• Full title

  Validation of the BODYSTAT­ Bioelectrical Impedance Analysis (BIA) device as a measure for quantifying and monitoring ankle swelling in patients awaiting surgery for ankle fracture fixation.

• IRAS ID

  192088

• Contact name

  Paul Baker

• Contact email

  Paul.Baker@stees.nhs.uk

• Sponsor organisation

  South Tees Hospitals NHS Foundation Trust

• Duration of Study in the UK

  0 years, 8 months, 0 days

• Research summary

  Ankle fracture (a broken ankle) is a common condition affecting a wide variety of patients in different age groups. In the UK, over 15,000 patients present with ankle fractures that require surgical fixation per year. It is not uncommon for such patients to develop ankle swelling following their injury due to associated soft tissue injury and haematoma (bleeding) from the fracture site. Operating on a swollen ankle can be hazardous as soft tissues are less pliant making closure of the wound difficult. Failure to properly manage the soft tissues prior to surgery can lead to intra­operative difficulties with wound closure, wound breakdown, exposure of underlying metalwork and associated infection. For these reasons, many surgeons prefer to delay surgery until the initial soft tissue swelling has subsided.

  Routine practice involves re­assessment of the degree of swelling on a daily basis based on a subjective assessment that varies between individuals. Currently, there is no objective method of measuring swelling that is routinely in use. This is because measuring swelling with the ankle in a plaster is technically difficult. This study intends to assess the usefulness of a bioimpedience device (the BODYSTAT BIA) as a tool for assessing swelling in ankle fracture patients. We intend to recruit a cohort of 20 patients admitted to the James Cook Hospital over a 6 months period that require surgery for an ankle fracture. These patients will undergo daily measurements of swelling using the bioimpedence device and tape measures placed within their plaster casts. This will continue until the time of surgery. This will allow us to assess the validity, reliability and responsiveness of the bioimpedence device in this patient population.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  15/SW/0341

• Date of REC Opinion

  30 Nov 2015

• REC opinion

  Further Information Favourable Opinion