The Amputation Surgical Site Infection Trial (ASSIT)

• Research type

  Research Study

• Full title

  A randomised control trial to determine whether a 5 day course of antibiotics is more clinically and cost effective than a 24 hour prophylactic course for the prevention of surgical site infection following lower limb amputation surgery

• IRAS ID

  93801

• Contact name

  Panos Souroullas

• Sponsor organisation

  Hull and East Yorkshire Hospital Trust

• Eudract number

  2012-003146-32

• Research summary

  Between 2003-2008 there were approximately 5 major amputations performed per 100,000 people equating to around 5,000 amputations per year in the UK. Figures from the Surgical Site Infection Surveillance report infection rates of 13.1% following lower limb amputations. Within our practice this figure is closure to 25% reflecting recent published work by Sadat et al. Perioperative mortality following lower limb amputation is unacceptably high and it is known that surgical site infections contribute to morbidity and mortality. Development of an SSI can result in delayed wound healing/ wound breakdown and as such increased inpatient stay, cost of treatment and delays in rehabilitation. The study by Sadat et al reported a significant reduction in infection rates with 5 days of antibiotics compared to a single prophylactic dose. A Cochrane review of skin antiseptics in clean surgery comprised data from only one trial (371 patients) which demonstrated cleansing with chlorhexidine- alcohol to be superior to povidone-iodine, for preventing SSI. However the trial had limited follow up. We intend to examine whether a 5 day course of antibiotics is more clinically and cost effective than a 24 hour prophylactic course at preventing SSI in amputation patients and perform subgroup analysis to investigate the impact of skin closure techniques and skin prep on infection rates.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  13/NW/0058

• Date of REC Opinion

  4 Mar 2013

• REC opinion

  Further Information Favourable Opinion