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| Name | Class |
|---|---|
| University of Hull | OTHER |
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As above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Iodine | Active Comparator | Skin Preparation used pre-operatively: Alcoholic Povidone |
|
| Chlorhexidine | Active Comparator | Skin preparation to be used preoperatively: Alcoholic chlorhexidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Co-amoxiclav | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of different skin preparations on infection rates | ASEPSIS Questionnaire score >21 | 30 days |
| Rate of re-intervention | Types of re-intervention: angioplasty, bypass, debridement, revision to higher level amputation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull Royal Infirmary | Hull | HU3 2JZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35325055 | Derived | 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. |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| D007455 | Iodine |
| D011206 | Povidone-Iodine |
| D008795 | Metronidazole |
| D002710 | Chlorhexidine |
| C107060 | Hydrex |
| D017334 | Teicoplanin |
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
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|
| Iodine | Drug | Intra-operative skin preparation prior to incision to skin. |
|
|
| Metronidazole | Drug | 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 |
|
|
| Chlorhexidine | Drug | Alcoholic Chlorhexidine skin pre-op preparation |
|
|
| Teicoplanin | Drug | Teicoplanin 400mg on induction. If penicillin allergic and on 5-day antibiotic arm then add clindamycin 300mg 4 times daily for further 4 days |
|
| Clindamycin | Drug | Clindamycin 300mg 4 times daily orally to be used in case of penicillin allergy |
|
| 30 days |
| Mortality | Mortality of a patient | 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. | 3 months |
| Quality of life Questionnaire | Assessed with Short form (SF)-12 questionnaire | 1 year |
| Resource use | length of stay, return to surgery, number of visits to general practitioners, hospital visits, and prescription of antibiotics. | up to 3 months |
| Rate of C. Diff., MSSA (Methicillin Sensitive Staphylococcus Aureus), MRSA (Methicillin Resistant Staphylococcus Aureus) infection | Infection progress | 30 days |
| Mobility | Locomotor Capabilities index - 5 | 1 year |
| Pain Control | McGill Pain questionnaire | 1 year |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D006219 | Halogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D000077427 | Lipoglycopeptides |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D006027 | Glycosides |