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Antimicrobial Stewardship in Pediatric Surgery

An Antimicrobial Stewardship Intervention Program in Pediatric Surgery

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02270996
Acronym
AbxPS
Enrollment
0
Registered
2014-10-22
Start date
2015-01-31
Completion date
2015-12-31
Last updated
2018-03-20

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

Conditions

Appendicitis

Keywords

antibiotic, antimicrobial, stewardship, child

Brief summary

Acute appendicitis is a common surgical emergency in children. Non-perforated appendicitis patients do not require antibiotics after appendectomy. Although guidelines and recommendations exist to decrease post-operative antibiotic mis-use after appendectomy, surgeons continue to prescribe unwarranted antibiotics. The aim of this study is to determine if an Antimicrobial Stewardship Program in Pediatric Surgery will decrease the use of un-warranted antibiotics.

Detailed description

Many surgeons continue to treat non-perforated or borderline perforated appendicitis with postoperative antibiotics despite an evidence-based definition of perforation (in the pediatric surgical literature) and many guidelines and recommendations that specify that no postoperative antibiotics are required. Children with perforated appendicitis are also often treated with longer-than-necessary courses of antibiotics. Although surgeons may feel that they only prescribe additional doses on occasion, evidence suggests that this behavior occurs in over 50% of children with non-perforated appendicitis. These additional doses contribute to a longer length of stay, excess costs to the health care system, and disrupt patient flow. Additionally, the patients are exposed to more antibiotics and their potential for adverse effects (such as incorrect dose, incorrect medication, allergic reaction, antimicrobial resistance or c difficile infection). Antimicrobial stewardship programs have been successful in pediatrics and adult general surgery in curbing unwarranted antibiotic use, but have never been evaluated in pediatric general surgery.

Interventions

OTHERAntimicrobial Stewardship Program

Twice weekly meeting with Infectious Disease and Pediatric Surgery team members to audit antibiotics prescribed and suggest role for discontinuation.

Sponsors

Alberta Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Participant (surgeon) is a pediatric surgeon at McMaster Children's Hospital and takes care of patients under the age of 18 who undergo appendectomy. * Participant (surgeon) is able to read, write and understand English. * Participant (surgeon) is able to provide informed consent.

Exclusion criteria

* Participant (surgeon) only has patients who undergo drain insertion, PICC line insertion or a secondary operation during the same admission * Participant (surgeon) only has patients who do not undergo operation (i.e. conservative management with interval appendectomy) * Participant (surgeon) does not provide informed consent * Participant (surgeon) does not understand written and spoken English diagnosis other than appendicitis at time of operation

Design outcomes

Primary

MeasureTime frameDescription
Compliance with American Pediatric Surgical Association recommendations for postoperative antibiotics for appendicitisFrom date of admission until first follow-up visit, typically within 4-6 weeks of dischargeIncludes both intravenous and oral antibiotics prescribed, both during the time frame from admission until discharge, in addition to any prescription given for home, oral antibiotics. Measured as yes/no

Secondary

MeasureTime frameDescription
Postoperative intravenous antibiotics for non-perforated appendicitisFrom date of admission until first follow-up visit, typically within 4-6 weeks of dischargemeasured as number of days (ie number of doses divided by number of doses-per-day)
Postoperative oral antibiotics for non-perforated appendicitisFrom date of admission until first follow-up visit, typically within 4-6 weeks of dischargemeasured as number of days (ie number of doses divided by number of doses-per-day)

Other

MeasureTime frameDescription
Drain insertionFrom date of admission until first follow-up visit, typically within 4-6 weeks of dischargeNeed for a drain insertion (by interventional radiology) for postoperative abscess, measured as yes/no
Re-operationFrom date of admission until first follow-up visit, typically within 4-6 weeks of dischargeNeed for re-operation on the same admission, measured as yes/no
Length of StayLength of admissionMeasured in days (from date of admission until date of discharge)
Postoperative feverLength of admissionRectal temperature above 100.4ºF (38ºC), measured as yes/no and on what postoperative day Oral temperature above 100ºF (37.8ºC) Axillary (armpit) temperature above 99ºF (37.2ºC) Ear (tympanic membrane) temperature above 100.4ºF (38ºC) in rectal mode or 99.5ºF (37.5ºC) in oral mode Forehead (temporal artery) temperature above 100.4ºF (38ºC)
Wrong medication/Wrong doseFrom date of admission until date of first follow-up visit, typically within 4-6 weeks of dischargeMeasured as yes/no in addition to description of problem (wrong dose, wrong medication)
C difficile infectionFrom date of admission until first follow-up visit, typically within 4-6 weeks of dischargeMeasured as yes/no based on stool assay
Adverse reaction to antibioticFrom date of admission until first follow-up visit, typically within 4-6 weeks of dischargeMeasured as yes/no in addition to description of reaction (eg hives, shortness of breath)
Readmission within 30 daysWithin 30 days of dischargeNeed for readmission within 30 days of discharge, measured as yes/no
Peripherally inserted intravenous catheter (PICC)From date of admission until first follow-up visit, typically within 4-6 weeks of dischargeNeed for PICC insertion for long term antibiotics, intravenous fluids or parenteral nutrition, measured as yes/no

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026