Clinical trial NCT02018094: The Amputation Surgical Site Infection Trial (ASSIT)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wound Infection
Amputation Wound
Keywords: Amputation
Infection
Skin Preparation
SSI
Stump
Wound
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Hull
First posted: 2013-12-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * 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.

Detailed description: As above

Eligibility criteria: Inclusion Criteria:

1. Adults ≥18 yrs undergoing lower limb amputations who are able to consent to the trial.
2. 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:

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

Primary outcomes:
measure: Surgical Site Infection
timeFrame: 30 days
Secondary outcomes:
measure: Impact of different skin preparations on infection rates
timeFrame: 30 days
measure: Rate of re-intervention
timeFrame: 30 days
measure: Mortality
timeFrame: 1 year
measure: Satisfactory healing rates
timeFrame: 3 months
measure: Quality of life Questionnaire
timeFrame: 1 year
measure: Resource use
timeFrame: up to 3 months
measure: Rate of C. Diff., MSSA (Methicillin Sensitive Staphylococcus Aureus), MRSA (Methicillin Resistant Staphylococcus Aureus) infection
timeFrame: 30 days
measure: Mobility
timeFrame: 1 year
measure: Pain Control
timeFrame: 1 year
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
Study officials:
References:
citation: Souroullas P, Barnes R, Carradice D, Smith G, Huang C, Chetter I. Extended-course antibiotic prophylaxis in lower limb amputation: randomized clinical trial. Br J Surg. 2022 Apr 19;109(5):426-432. doi: 10.1093/bjs/znac053.