The Amputation Surgical Site Infection Trial (ASSIT)

NHS Trust

Status and phase: Completed; Phase 4

Conditions: Amputation Wound; Wound Infection

Treatments: Drug: Clindamycin; Drug: Metronidazole; Drug: Chlorhexidine; Drug: Teicoplanin; Drug: Iodine; Drug: Co-amoxiclav

Study type: Interventional

Funder types: Other

Identifiers

NCT02018094

ASSIT Trial

Details and patient eligibility

About

• 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.

Full description

As above

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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160 participants in 4 patient groups

24 hour antibiotic course

Active Comparator group

Description:

24 hours of the stated antibiotics administered intravenously (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function)

Treatment:

Drug: Co-amoxiclav

Drug: Iodine

Drug: Teicoplanin

Drug: Chlorhexidine

Drug: Metronidazole

5 day antibiotic Course

Active Comparator group

Description:

24 hours of IV antibiotics followed by 4 days of oral antibiotics (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function. Clindamycin will be used as a an oral replacement for penicillin allergic patients)

Treatment:

Drug: Co-amoxiclav

Drug: Iodine

Drug: Teicoplanin

Drug: Chlorhexidine

Drug: Clindamycin

Drug: Metronidazole

Iodine

Active Comparator group

Description:

Skin Preparation used pre-operatively: Alcoholic Povidone

Treatment:

Drug: Co-amoxiclav

Drug: Iodine

Drug: Teicoplanin

Drug: Clindamycin

Drug: Metronidazole

Chlorhexidine

Active Comparator group

Description:

Skin preparation to be used preoperatively: Alcoholic chlorhexidine

Treatment:

Drug: Co-amoxiclav

Drug: Teicoplanin

Drug: Chlorhexidine

Drug: Clindamycin

Drug: Metronidazole