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Risks of preventative antibiotics for surgery

Safe Antimicrobial ProPhylaxis for surgery study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15775657
Enrollment
13720
Registered
2022-03-30
Start date
2022-03-31
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Use of antimicrobials as prophylaxis in surgical patients Surgery

Interventions

Observational study of routinely collected data relating to clinical care before and after surgery. Patient information will be collected on antibiotic use during and after surgery. The data collectio

Sponsors

Barts Health NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 years or over undergoing one of the following surgeries: 1. Primary hip or knee replacement 2. Internal fixation of a closed long bone fracture (upper or lower limb) 3. Colorectal resection 4. Trans-urethral resection of prostate or bladder tumour 5. Caesarean section 6. Hysterectomy (vaginal or abdominal)

Exclusion criteria

Exclusion criteria: 1. Use of antibiotics in the 2 weeks prior to surgery 2. Previous participation in the study

Design outcomes

Primary

MeasureTime frame
Surgical site infection (bacteriuria for urological surgery) within 30 days after surgery (US Centre for Disease Control Criteria), including: 1. Superficial surgical site infection data collected from medical notes and graded according to Clavien-Dindo Grading within 30 days after surgery 2. Deep surgical site infection data collected from medical notes and graded according to Clavien-Dindo Grading within 30 days after surgery 3. Organ space surgical site infection data collected from medical notes and graded according to Clavien-Dindo Grading within 30 days after surgery 4. Urinary tract infection or bacteriuria data collected from medical notes and graded according to Clavien-Dindo Grading within 30 days after surgery

Secondary

MeasureTime frame
1. Number of antimicrobials to treat an infection, collected from medical notes within 30 days after surgery 2. Incidence of antimicrobial side effects within 30 days after surgery: 2.1. Acute kidney injury of any cause, collected from medical notes and graded according to Clavien-Dindo Grading within 30 days after surgery 2.2. Diarrhoeal illness of any cause, collected from medical notes and graded according to Clavien-Dindo Grading within 30 days after surgery 2.3. Hearing loss, tinnitus or vertigo of any cause, collected from medical notes and graded according to Clavien-Dindo Grading within 30 days after surgery 2.4. Suspected allergic reaction to antimicrobials, collected from medical notes within 30 days of surgery and graded according to Ring and Messmer grading, grades 1-4 3. Suspected allergic reaction to any other drug, collected from medical notes within 30 days after surgery according to Ring and Messmer grading, grades 1-4 4. Incidence of postoperative infection within 30 days after surgery, collected from medical notes and graded according to Clavien-Dindo Grading within 30 days after surgery 5. Incidence of all postoperative complications within 30 days after surgery, collected from medical notes and graded according to Clavien-Dindo Grading 6. Mortality at 30 days data collected from patients' medical notes

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Sep 12, 2026