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Completed

NCT Number: NCT02018094

The Amputation Surgical Site Infection Trial (ASSIT)

* Lower limb amputations are performed usually as a last resort in patients with acute and chronic limb ischaemia (CLI) caused by vascular disease, poorly controlled diabetes or, infection. * In the period 2003-2008 there were approximately 5,000 amputations per year in the UK. * The Centre for Disease Control defines a Surgical Site Infection (SSI) as an infection within 30 days of an operation or up to one year if an implant is left in place and the infection is related to an operative procedure. * Figures from the Surgical Site Infection Surveillance reported that the highest rate of surgical site infection was reported in association with lower limb amputation at 13.1%. * There is a clear under-representation and the infection rate within our institution is approximately 25% which reflects the infection rate reported in a recent trial by Sadat et al (22.5%) * Prevention of surgical site infections is of paramount importance to patients, healthcare providers and policy-makers, as they impact on morbidity and mortality and have significant time and cost implications. * Currently there is NO CONSENSUS as to what the best practice is towards antibiotic administration in such patients. From a questionnaire-based audit we performed including vascular departments across the entire country, practice varies in both course duration (single dose → 5 days antibiotic course) as well as choice of antibiotics. * The guideline at our institution suggests the 5-day course of antibiotic prophylaxis. The course duration varies depending on the clinical picture as well as microbiology results and recommendations. * There are no randomised control trials that have investigated this aspect of patient care. We have set up one such trial and through it, we are looking to establish a standard practice which will hopefully be as beneficial as possible to the patient but also cost-effective for NHS.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

About this study

As above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥18 yrs undergoing lower limb amputations who are able to consent to the trial.
  • Able to understand the Patient Information Sheet and capable and willing to give informed consent and follow the protocol requirements (including attending all follow-up visits)

Exclusion criteria

  • Allergies to chlorhexidine/ alcohol/ iodophors
  • Inability to give informed consent
  • Patients who are admitted to hospital with severe sepsis secondary to gas gangrene requiring multiple operations and admission to Intensive Care Unit.
  • Aged under 18 years at the time of recruitment
  • Use of investigational drug/device therapy within preceding 4 weeks that may interfere with this study.
  • Toe amputations

Treatment and study plan

Co-amoxiclav

Drug

Augmentin 1.2g IV three times daily for 24 hours. If the patient is randomised to the 5-day duration antibiotic arm then Augmentin 625mg oral tablets three times daily are added to the 24 hour course for a further 4 days.

Other names: Augmentin

Iodine

Drug

Intra-operative skin preparation prior to incision to skin.

Other names: Povidone iodine (alcoholic solution)

Metronidazole

Drug

500mg IV three times daily for 24 hours. If the patient is randomised to 5-day duration arm, then another 4 days of oral metronidazole at 400mg three times daily is added to the course

Other names: Flagyl

Chlorhexidine

Drug

Alcoholic Chlorhexidine skin pre-op preparation

Other names: Hydrex

Teicoplanin

Drug

Teicoplanin 400mg on induction. If penicillin allergic and on 5-day antibiotic arm then add clindamycin 300mg 4 times daily for further 4 days

Clindamycin

Drug

Clindamycin 300mg 4 times daily orally to be used in case of penicillin allergy

Primary outcomes

  1. Surgical Site Infection

    Time frame: 30 days

    Primary objective: to establish the effect of 5 days of antibiotics versus a 24-hour prophylactic course on the incidence of surgical site infection (SSI) - total ASEPSIS score >21

Secondary outcomes

  1. Impact of different skin preparations on infection rates

    Time frame: 30 days

    ASEPSIS Questionnaire score >21

  2. Rate of re-intervention

    Time frame: 30 days

    Types of re-intervention: angioplasty, bypass, debridement, revision to higher level amputation.

  3. Mortality

    Time frame: 1 year

    Mortality of a patient

  4. Satisfactory healing rates

    Time frame: 3 months

    Metric Measurement. Asepsis score derived by HPA post-discharge questionnaire. Clinical examination, quality of life, time to prosthesis also recorded.

  5. Quality of life Questionnaire

    Time frame: 1 year

    Assessed with Short form (SF)-12 questionnaire

  6. Resource use

    Time frame: up to 3 months

    length of stay, return to surgery, number of visits to general practitioners, hospital visits, and prescription of antibiotics.

  7. Rate of C. Diff., MSSA (Methicillin Sensitive Staphylococcus Aureus), MRSA (Methicillin Resistant Staphylococcus Aureus) infection

    Time frame: 30 days

    Infection progress

  8. Mobility

    Time frame: 1 year

    Locomotor Capabilities index - 5

  9. Pain Control

    Time frame: 1 year

    McGill Pain questionnaire

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • University of Hull

Registry information

Official study 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

Acronym: ASSIT

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Dec 23, 2013
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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