Association of the type of antibiotics used at the time of appendix removal in children with appendicitis with wound infections after the surgery
| ISRCTN | ISRCTN47727811 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47727811 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Swiss SSI Surveillance |
| Sponsor | University of Basel Children's Hospital |
| Funder | Investigator initiated and funded |
- Submission date
- 09/02/2023
- Registration date
- 23/02/2023
- Last edited
- 26/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims:
The aim of this study is to find out whether the type of antibiotics given at the time children are undergoing removal of their appendix for uncomplicated appendicitis is better than the next most commonly used alternative in terms of children experiencing wound infections in the 4 weeks after surgery.
Who can participate?
Children up to the age of 16 years who have had their appendix removed for uncomplicated appendicitis during the time period from 01/01/2014 to 31/12/2018 and whose data were collected during routine surveillance carried out in Switzerland
What does the study involve?
The study only analyses data available through mandatory routine surveillance in Switzerland.
What are the possible benefits and risks of participating?
The study does not pose a risk nor present a benefit for children whose data are analysed.
Where is the study run from?
University of Basel Children's Hospital (Switzerland)
When is the study starting and how long is it expected to run for?
December 2018 to December 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Julia Bielicki, jbielick@sgul.ac.uk
Contact information
Scientific
Spitalstrasse 33
Basel
4056
Switzerland
| Phone | +41 (0)617041212 |
|---|---|
| julia.bielicki@ukbb.ch |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Association between perioperative prophylaxis with cefuroxime plus metronidazole or amoxicillin/clavulanic acid and surgical site infections in pediatric appendectomy: a Swiss retrospective cohort study |
| Study objectives | Evidence supporting the use of specific antibiotic regimes in perioperative antibiotic prophylaxis administered in children undergoing appendectomy for uncomplicated appendicitis is limited. It is hypothesised that a cephalosporin-based regimen may be more effective than a non-cephalosporin-based regimen. |
| Ethics approval(s) | Approved 22/01/2019, the local ethics committee (Ethikkommission Zentral- und Nordwestschweiz [EKNZ], Ethikkommission Nordwest- und Zentralschweiz (EKNZ), Hebelstrasse 53, 4056 Basel, Switzerland; +41 (0)61 268 13 50; eknz@bs.ch), ref: 2018-02252 |
| Health condition(s) or problem(s) studied | Children undergoing appendectomy for uncomplicated appendicitis |
| Intervention | The study only analyses data available through mandatory routine surveillance in Switzerland. All children up to the age of 16 years who have had their appendix removed for uncomplicated appendicitis during the time period from 01/01/2014 to 31/12/2018 and whose data were collected during routine surveillance carried out in Switzerland are included. The interventions of interest for the comparative effectiveness analysis are the application of perioperative antibiotic prophylaxis with amoxicillin/clavulanate or cefuroxime plus metronidazole as recorded in mandatory national surgical site infection surveillance in Switzerland. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Amoxicillin/clavulanate (intravenous application), cefuroxime plus metronidazole (intravenous application) |
| Primary outcome measure(s) |
Surgical site infections (SSIs) up to 30 days after appendectomy as captured within the Swiss national SSI surveillance programme |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 3839 |
| Total final enrolment | 3839 |
| Key inclusion criteria | Patients up to 16 years of age undergoing appendectomy for uncomplicated appendicitis in the study period from 2014 to 2018 in Switzerland |
| Key exclusion criteria | 1. Older than 16 years of age 2. Appendectomy carried out for complicated appendicitis (perforated, established abscess) 3. Receipt of antibiotics for perioperative prophylaxis other than the two target regimens 4. No perioperative antibiotic prophylaxis applied 5. Patients with missing procedure-related data |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Basel
4056
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request from Dr Julia Bielicki (julia.bielicki@ukbb.ch). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/09/2023 | 26/09/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/09/2023: Publication reference added.
21/02/2023: Trial's existence confirmed by the Ethikkommission Zentral- und Nordwestschweiz.
