The Amputation Surgical Site Infection Trial (ASSIT)

Phase 4

Completed

• Conditions: Wound Infection; Amputation Wound
• Interventions: Drug: Co-amoxiclav; Drug: Iodine; Drug: Metronidazole; Drug: Chlorhexidine; Drug: Clindamycin; Drug: Teicoplanin

• Registration Number: NCT02018094
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

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

Study Timeline

• Study Start: 2013-10-08
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-23
• Primary Completion: 2014-03-01
• Study Completion: 2017-01-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
24 hour antibiotic course	Co-amoxiclav	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)
5 day antibiotic Course	Co-amoxiclav	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)
Iodine	Co-amoxiclav	Skin Preparation used pre-operatively: Alcoholic Povidone
Iodine	Clindamycin	Skin Preparation used pre-operatively: Alcoholic Povidone
Chlorhexidine	Co-amoxiclav	Skin preparation to be used preoperatively: Alcoholic chlorhexidine
24 hour antibiotic course	Iodine	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)
24 hour antibiotic course	Metronidazole	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)
24 hour antibiotic course	Chlorhexidine	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)
24 hour antibiotic course	Teicoplanin	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)
5 day antibiotic Course	Iodine	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)
5 day antibiotic Course	Metronidazole	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)
5 day antibiotic Course	Teicoplanin	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)
Iodine	Iodine	Skin Preparation used pre-operatively: Alcoholic Povidone
5 day antibiotic Course	Chlorhexidine	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)
5 day antibiotic Course	Clindamycin	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)
Iodine	Metronidazole	Skin Preparation used pre-operatively: Alcoholic Povidone
Iodine	Teicoplanin	Skin Preparation used pre-operatively: Alcoholic Povidone
Chlorhexidine	Metronidazole	Skin preparation to be used preoperatively: Alcoholic chlorhexidine
Chlorhexidine	Chlorhexidine	Skin preparation to be used preoperatively: Alcoholic chlorhexidine
Chlorhexidine	Teicoplanin	Skin preparation to be used preoperatively: Alcoholic chlorhexidine
Chlorhexidine	Clindamycin	Skin preparation to be used preoperatively: Alcoholic chlorhexidine

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection	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 Outcome Measures

Name	Time	Method
Mobility	1 year	Locomotor Capabilities index - 5
Satisfactory healing rates	3 months	Metric Measurement. Asepsis score derived by HPA post-discharge questionnaire. Clinical examination, quality of life, time to prosthesis also recorded.
Resource use	up to 3 months	length of stay, return to surgery, number of visits to general practitioners, hospital visits, and prescription of antibiotics.
Quality of life Questionnaire	1 year	Assessed with Short form (SF)-12 questionnaire
Rate of C. Diff., MSSA (Methicillin Sensitive Staphylococcus Aureus), MRSA (Methicillin Resistant Staphylococcus Aureus) infection	30 days	Infection progress
Rate of re-intervention	30 days	Types of re-intervention: angioplasty, bypass, debridement, revision to higher level amputation.
Mortality	1 year	Mortality of a patient
Impact of different skin preparations on infection rates	30 days	ASEPSIS Questionnaire score \>21
Pain Control	1 year	McGill Pain questionnaire

Trial Locations

Locations (1)

Hull Royal Infirmary; 🇬🇧 Hull, United Kingdom