Wound InfectionPhase 4ASSITNCT02018094
The Amputation Surgical Site Infection Trial (ASSIT)
A Phase 4 study testing Co-amoxiclav, Iodine and Metronidazole in people with Wound Infection and Amputation Wound, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection, Amputation Wound
- What is being tested?
- Co-amoxiclav, Iodine and Metronidazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Oct 2013to 2 Jan 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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.
Read the detailed description
As above
- Conditions
- Wound Infection, Amputation Wound
- Being tested
- Co-amoxiclav, Iodine, Metronidazole, Chlorhexidine, Teicoplanin
- Keywords
- Amputation, Infection, Skin Preparation, SSI, Stump, Wound
- Medical subject headings
- Wound Infection, Infections, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-amoxiclavDrug
Also called Augmentin
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.
IodineDrug
Also called Povidone iodine (alcoholic solution)
Intra-operative skin preparation prior to incision to skin.
MetronidazoleDrug
Also called Flagyl
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
ChlorhexidineDrug
Also called Hydrex
Alcoholic Chlorhexidine skin pre-op preparation
TeicoplaninDrug
Teicoplanin 400mg on induction. If penicillin allergic and on 5-day antibiotic arm then add clindamycin 300mg 4 times daily for further 4 days
ClindamycinDrug
Clindamycin 300mg 4 times daily orally to be used in case of penicillin allergy
| Study group | Role | What they receive |
|---|---|---|
| 24 hour antibiotic course | Active comparator | 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) Receives: Drug: Co-amoxiclav; Drug: Iodine; Drug: Metronidazole; Drug: Chlorhexidine; Drug: Teicoplanin |
| 5 day antibiotic Course | Active comparator | 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) Receives: Drug: Co-amoxiclav; Drug: Iodine; Drug: Metronidazole; Drug: Chlorhexidine; Drug: Teicoplanin; Drug: Clindamycin |
| Iodine | Active comparator | Skin Preparation used pre-operatively: Alcoholic Povidone Receives: Drug: Co-amoxiclav; Drug: Iodine; Drug: Metronidazole; Drug: Teicoplanin; Drug: Clindamycin |
| Chlorhexidine | Active comparator | Skin preparation to be used preoperatively: Alcoholic chlorhexidine Receives: Drug: Co-amoxiclav; Drug: Metronidazole; Drug: Chlorhexidine; Drug: Teicoplanin; Drug: Clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
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
Measured: 30 days
Secondary outcomes (9)
Impact of different skin preparations on infection rates
ASEPSIS Questionnaire score >21
Measured: 30 days
Rate of re-intervention
Types of re-intervention: angioplasty, bypass, debridement, revision to higher level amputation.
Measured: 30 days
Mortality
Mortality of a patient
Measured: 1 year
Satisfactory healing rates
Metric Measurement. Asepsis score derived by HPA post-discharge questionnaire. Clinical examination, quality of life, time to prosthesis also recorded.
Measured: 3 months
Quality of life Questionnaire
Assessed with Short form (SF)-12 questionnaire
Measured: 1 year
Resource use
length of stay, return to surgery, number of visits to general practitioners, hospital visits, and prescription of antibiotics.
Measured: up to 3 months
Rate of C. Diff., MSSA (Methicillin Sensitive Staphylococcus Aureus), MRSA (Methicillin Resistant Staphylococcus Aureus) infection
Infection progress
Measured: 30 days
Mobility
Locomotor Capabilities index - 5
Measured: 1 year
Pain Control
McGill Pain questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study start8 Oct 2013
- Primary completion1 Mar 2014
- Study completion2 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018094
- Sponsor's protocol ID
- ASSIT Trial
- Acronym
- ASSIT
- Status last verified
- Jul 2019
- First submitted
- 5 Dec 2013
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35325055
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02018094
- Acronym / sponsor ID
- ASSIT / ASSIT Trial
- Conditions
- Wound Infection, Amputation Wound
- Keywords
- Amputation, Infection, Skin Preparation, SSI, Stump, Wound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- 8 Oct 2013 (actual)
- Primary completion
- 1 Mar 2014 (actual)
- Study completion
- 2 Jan 2017 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 24 hour antibiotic course | Active comparator | Drug: Co-amoxiclav, Drug: Iodine, Drug: Metronidazole, Drug: Chlorhexidine, Drug: Teicoplanin24 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 | Active comparator | Drug: Co-amoxiclav, Drug: Iodine, Drug: Metronidazole, Drug: Chlorhexidine, Drug: Teicoplanin, Drug: Clindamycin24 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 | Active comparator | Drug: Co-amoxiclav, Drug: Iodine, Drug: Metronidazole, Drug: Teicoplanin, Drug: ClindamycinSkin Preparation used pre-operatively: Alcoholic Povidone |
| Chlorhexidine | Active comparator | Drug: Co-amoxiclav, Drug: Metronidazole, Drug: Chlorhexidine, Drug: Teicoplanin, Drug: ClindamycinSkin preparation to be used preoperatively: Alcoholic chlorhexidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-amoxiclavAlso: AugmentinAugmentin 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. | Drug | 24 hour antibiotic course, 5 day antibiotic Course, Chlorhexidine, Iodine |
| IodineAlso: Povidone iodine (alcoholic solution)Intra-operative skin preparation prior to incision to skin. | Drug | 24 hour antibiotic course, 5 day antibiotic Course, Iodine |
| MetronidazoleAlso: Flagyl500mg 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 | Drug | 24 hour antibiotic course, 5 day antibiotic Course, Chlorhexidine, Iodine |
| ChlorhexidineAlso: HydrexAlcoholic Chlorhexidine skin pre-op preparation | Drug | 24 hour antibiotic course, 5 day antibiotic Course, Chlorhexidine |
| TeicoplaninTeicoplanin 400mg on induction. If penicillin allergic and on 5-day antibiotic arm then add clindamycin 300mg 4 times daily for further 4 days | Drug | 24 hour antibiotic course, 5 day antibiotic Course, Chlorhexidine, Iodine |
| ClindamycinClindamycin 300mg 4 times daily orally to be used in case of penicillin allergy | Drug | 5 day antibiotic Course, Chlorhexidine, Iodine |
Primary outcome
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
9 secondary outcomes
Impact of different skin preparations on infection rates
Time frame: 30 days
Rate of re-intervention
Time frame: 30 days
Mortality
Time frame: 1 year
Satisfactory healing rates
Time frame: 3 months
Quality of life Questionnaire
Time frame: 1 year
Resource use
Time frame: up to 3 months
Rate of C. Diff., MSSA (Methicillin Sensitive Staphylococcus Aureus), MRSA (Methicillin Resistant Staphylococcus Aureus) infection
Time frame: 30 days
Mobility
Time frame: 1 year
Pain Control
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Derived from this study: PubMed 35325055Souroullas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Co-amoxiclav, Iodine and Metronidazole in people with Wound Infection and Amputation Wound, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02018094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.