The Amputation Surgical Site Infection Trial (ASSIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Hull
Sponsor:
Information provided by (Responsible Party):
Daniel Carradice, University of Hull
ClinicalTrials.gov Identifier:
NCT02018094
First received: December 5, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose
  • 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.

Condition Intervention Phase
Wound Infection
Amputation Wound
Drug: Co-amoxiclav
Drug: Iodine
Drug: Metronidazole
Drug: Chlorhexidine
Drug: Teicoplanin
Drug: Clindamycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Hull:

Primary Outcome Measures:
  • Surgical Site Infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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:
  • Impact of different skin preparations on infection rates [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    ASEPSIS Questionnaire score >21

  • Rate of re-intervention [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Types of re-intervention: angioplasty, bypass, debridement, revision to higher level amputation.

  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Satisfactory healing rates [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessed with Short form (SF)-12 questionnaire

  • Resource use [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    length of stay, return to surgery, number of visits to general practitioners, hospital visits, and prescription of antibiotics.

  • • Rate of C. Diff., MSSA (Methicillin Sensitive Staphylococcus Aureus), MRSA (Methicillin Resistant Staphylococcus Aureus) infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Mobility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Locomotor Capabilities index - 5

  • Pain Control [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    McGill Pain questionnaire


Estimated Enrollment: 164
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 24 hour antibiotic course
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)
Drug: Co-amoxiclav
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 Name: Augmentin
Drug: Iodine
Intra-operative skin preparation prior to incision to skin.
Other Name: Povidone iodine (alcoholic solution)
Drug: Metronidazole
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 Name: Flagyl
Drug: Chlorhexidine
Alcoholic Chlorhexidine skin pre-op preparation
Other Name: Hydrex
Drug: Teicoplanin
Teicoplanin 400mg on induction. If penicillin allergic and on 5-day antibiotic arm then add clindamycin 300mg 4 times daily for further 4 days
Active Comparator: 5 day antibiotic Course
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)
Drug: Co-amoxiclav
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 Name: Augmentin
Drug: Iodine
Intra-operative skin preparation prior to incision to skin.
Other Name: Povidone iodine (alcoholic solution)
Drug: Metronidazole
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 Name: Flagyl
Drug: Chlorhexidine
Alcoholic Chlorhexidine skin pre-op preparation
Other Name: Hydrex
Drug: Teicoplanin
Teicoplanin 400mg on induction. If penicillin allergic and on 5-day antibiotic arm then add clindamycin 300mg 4 times daily for further 4 days
Drug: Clindamycin
Clindamycin 300mg 4 times daily orally to be used in case of penicillin allergy
Active Comparator: Iodine
Skin Preparation used pre-operatively: Alcoholic Povidone
Drug: Co-amoxiclav
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 Name: Augmentin
Drug: Iodine
Intra-operative skin preparation prior to incision to skin.
Other Name: Povidone iodine (alcoholic solution)
Drug: Metronidazole
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 Name: Flagyl
Drug: Teicoplanin
Teicoplanin 400mg on induction. If penicillin allergic and on 5-day antibiotic arm then add clindamycin 300mg 4 times daily for further 4 days
Drug: Clindamycin
Clindamycin 300mg 4 times daily orally to be used in case of penicillin allergy
Active Comparator: Chlorhexidine
Skin preparation to be used preoperatively: Alcoholic chlorhexidine
Drug: Co-amoxiclav
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 Name: Augmentin
Drug: Metronidazole
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 Name: Flagyl
Drug: Chlorhexidine
Alcoholic Chlorhexidine skin pre-op preparation
Other Name: Hydrex
Drug: Teicoplanin
Teicoplanin 400mg on induction. If penicillin allergic and on 5-day antibiotic arm then add clindamycin 300mg 4 times daily for further 4 days
Drug: Clindamycin
Clindamycin 300mg 4 times daily orally to be used in case of penicillin allergy

Detailed Description:

As above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018094

Contacts
Contact: Panos Souroullas, MBChB 00447748492992 panos.souroullas@hey.nhs.uk

Locations
United Kingdom
Hull Royal Infirmary Recruiting
Hull, United Kingdom, HU3 2JZ
Contact: Panos Souroullas, MBChB, MRCS    00447748492992    panos.souroullas@hey.nhs.uk   
Principal Investigator: Panos Souroullas, MBChB, MRCS         
Sponsors and Collaborators
University of Hull
  More Information

No publications provided

Responsible Party: Daniel Carradice, Mr Panos Souroullas ( Research Fellow HRI), University of Hull
ClinicalTrials.gov Identifier: NCT02018094     History of Changes
Other Study ID Numbers: ASSIT Trial
Study First Received: December 5, 2013
Last Updated: December 16, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Hull:
Amputation
Infection
Skin Preparation
SSI
Stump
Wound

Additional relevant MeSH terms:
Wound Infection
Infection
Wounds and Injuries
Anti-Bacterial Agents
Clindamycin
Clindamycin-2-phosphate
Amoxicillin-Potassium Clavulanate Combination
Teicoplanin
Antibiotics, Antitubercular
Povidone
Chlorhexidine
Chlorhexidine gluconate
Iodine
Cadexomer iodine
Povidone-Iodine
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trace Elements

ClinicalTrials.gov processed this record on July 23, 2014