Risks of preventative antibiotics for surgery
| ISRCTN | ISRCTN15775657 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15775657 |
| IRAS number | 282161 |
| Secondary identifying numbers | IRAS 282161, CPMS 51951, Protocol version 1.0 15/12/2021 |
- Submission date
- 11/03/2022
- Registration date
- 30/03/2022
- Last edited
- 06/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The use of antibiotics to prevent surgical wound (surgical site) infection is an accepted cornerstone of modern healthcare. This type of infection occurs in or around the incision a surgeon makes and affects 1 in 20 patients after surgery. In the UK, around 7 million doses of antibiotics are used each year to prevent these infections. However, the evidence supporting this practice is relatively weak and predates the use of modern surgical and anaesthetic techniques that have reduced the risk of wound infections. At the same time, there is evidence that antibiotics may be causing harm, both to individual patients and to society. An estimated 1 in 50 surgical patients have a complication directly caused by antibiotics, including kidney damage, hearing loss and allergic reactions.
As well as these well-known antibiotic harms, there are additional but poorly recognised problems in patients who report an antibiotic allergy. Up to 1 in 7 patients are labelled as allergic to an antibiotic, but the majority are not truly allergic to the antibiotic in question and therefore receive alternative antibiotics unnecessarily. The alternative antibiotic may be less effective in preventing surgical wound infection, while at the same time increasing the risk of side effects. For society, the widespread use of antibiotics leads to the development of bacteria that are resistant to these drugs, so-called antimicrobial resistance. This is recognised as a major global threat to public health. We urgently need to understand the risks and harms associated with preventive antibiotic use, so we can ensure the best possible use of these drugs, whilst minimising harm to patients.
Who can participate?
Patients aged 18 years or over undergoing one of the following surgeries: primary hip or knee replacement, internal fixation of a closed long bone fracture (upper or lower limb), colorectal resection, trans-urethral resection of prostate or bladder tumour, caesarean section, or hysterectomy (vaginal or abdominal)
What does the study involve?
To describe the relationship between preventative antibiotic use in surgery, surgical wound infections and antibiotic side effects, the researchers will assess any effect of preventive antibiotics on the frequency of wound infections after surgery, assess whether wound infections are more common for patients with antibiotic allergy labels, and describe the frequency of side effects and harms of antibiotics.
What are the possible benefits and risks of participating?
There are no risks or benefits of taking part in this study as this is an observational study.
Where is the study run from?
Barts Health NHS Trust (UK)
When is the study starting and how long is it expected to run for?
December 2021 to September 2024
Who is funding the study?
1. British Journal of Anaesthesia/ Royal College of Anaesthetists project grant (WKR0-2020-0020) (UK)
2. NIHR Doctoral Fellowship (NIHR301454) (UK)
Who is the main contact?
Dr Tom Abbott, t.abbott@qmul.ac.uk
Dr Louise Savic, louise.savic@nhs.net
Contact information
Principal Investigator
Adult Critical Care Unit
Barts Health NHS Trust
Whitechapel Road
London
E1 1FR
United Kingdom
 ORCID ID |
0000-0002-8664-3001 |
|---|---|
| Phone | +44 (0)2035940351 |
| t.abbott@qmul.ac.uk |
Study information
| Study design | Multi-centre observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | Safe Antimicrobial ProPhylaxis for surgery study |
| Study acronym | SAPPHIRE |
| Study objectives | The aims of the study are to provide detailed data describing the clinical effectiveness of antimicrobial prophylaxis and define the risks of harm during the perioperative period. This will include: 1. An understanding of the treatment effect of antimicrobial prophylaxis in preventing surgical site infection (SSI) 2. Description of clinically relevant harm associated with the use of antimicrobial prophylaxis 3. Details of any association between drug allergy labels and SSI |
| Ethics approval(s) | Approved 03/02/2022, Yorkshire and the Humber- Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle Upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8083; bradfordleeds.rec@hra.nhs.uk), ref: 22/YH/0040 |
| Health condition(s) or problem(s) studied | Use of antimicrobials as prophylaxis in surgical patients |
| Intervention | 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 collection period is for 30 days after the surgical procedure. The exposures of interest are the use of antimicrobial drugs to prevent surgical infection and the presence of an allergy label. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 15/12/2021 |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 13720 |
| Key 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) |
| Key exclusion criteria | 1. Use of antibiotics in the 2 weeks prior to surgery 2. Previous participation in the study |
| Date of first enrolment | 31/03/2022 |
| Date of final enrolment | 01/08/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
80 Newark Street
London
E1 2ES
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Hospital/treatment centre
Research Services, Dept W
69-89 Mile End Road
London
E1 4UJ
England
United Kingdom
| Phone | +44 (0)207 882 7275/6574 |
|---|---|
| research.governance@qmul.ac.uk | |
| Website | http://www.bartshealth.nhs.uk/ |
"ROR" |
https://ror.org/00b31g692 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- British Journal of Anaesthesia Ltd, BJA
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/11/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 01/11/2023 to 01/08/2024.
2. The overall study end date was changed from 01/11/2023 to 30/09/2024.
3. The intention to publish date was changed from 01/11/2024 to 01/09/2025.
01/04/2022: The recruitment start date has been changed from 01/04/2022 to 31/03/2022.
25/03/2022: Trial's existence confirmed by Barts Health NHS Trust.
