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
Secondary identifying numbers	Swiss SSI Surveillance

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Study website

Contact information

Dr Julia Bielicki
Scientific

Spitalstrasse 33
Basel
4056
Switzerland

Phone	+41 (0)617041212
Email	julia.bielicki@ukbb.ch

Study information

Study design	Retrospective cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Community, Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Amoxicillin/clavulanate (intravenous application), cefuroxime plus metronidazole (intravenous application)
Primary outcome measure	Surgical site infections (SSIs) up to 30 days after appendectomy as captured within the Swiss national SSI surveillance programme
Secondary outcome measures	There are no secondary outcome measures
Overall study start date	01/12/2018
Completion date	31/12/2019

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	16 Years
Sex	Both
Target number of participants	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

University of Basel Children's Hospital

Spitalstrasse 33
Basel
4056
Switzerland

Sponsor information

University of Basel Children's Hospital
Hospital/treatment centre

Spitalstrasse 33
Basel
4056
Switzerland

Phone	+41 (0)617041212
Email	sven.schulzke@ukbb.ch
Website	https://www.ukbb.ch

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/07/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The researchers plan to submit the results of the study to a high-impact peer-reviewed journal
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

Editorial Notes

26/09/2023: Publication reference added.
21/02/2023: Trial's existence confirmed by the Ethikkommission Zentral- und Nordwestschweiz.