Trial Outcomes & Findings for Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS) (NCT NCT03261830)

Results Overview

The primary outcome measure will be the presence of infection as judged by the blinded attending surgeon at the time of cast removal. A superficial infection is defined as a clinical diagnosis based on increased erythema, granulation tissue or purulence at the pin sites that resolves with a short course of oral antibiotics. A deep infection is defined as the presence of septic arthritis or osteomyelitis requiring return to the operating room for debridement or a prolonged course of IV antibiotics. If the attending physician determines that a deep or superficial infection is present at any time during the treatment period the patient will be categorized as infected.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

160 participants

Primary outcome timeframe

Six weeks

Results posted on

2024-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Pre-operative Antibiotics Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin. Cefazolin: Primary intervention Clindamycin: For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.	Saline Placebo Patients randomized to the no-antibiotic group will receive a saline placebo. This placebo will consist of a 10 mL pre-filled syringe of normal saline. Saline: Placebo Intervention
Overall Study STARTED	82	78
Overall Study COMPLETED	82	78
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-operative Antibiotics n=82 Participants Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin. Cefazolin: Primary intervention Clindamycin: For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.	Saline Placebo n=78 Participants Patients randomized to the no-antibiotic group will receive a saline placebo. This placebo will consist of a 10 mL pre-filled syringe of normal saline. Saline: Placebo Intervention	Total n=160 Participants Total of all reporting groups
Sex: Female, Male Male	42 Participants n=82 Participants	31 Participants n=78 Participants	73 Participants n=160 Participants
Age, Continuous	5.9 Years n=82 Participants	5.5 Years n=78 Participants	5.67 Years n=160 Participants
Sex: Female, Male Female	40 Participants n=82 Participants	47 Participants n=78 Participants	87 Participants n=160 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Six weeks

The primary outcome measure will be the presence of infection as judged by the blinded attending surgeon at the time of cast removal. A superficial infection is defined as a clinical diagnosis based on increased erythema, granulation tissue or purulence at the pin sites that resolves with a short course of oral antibiotics. A deep infection is defined as the presence of septic arthritis or osteomyelitis requiring return to the operating room for debridement or a prolonged course of IV antibiotics. If the attending physician determines that a deep or superficial infection is present at any time during the treatment period the patient will be categorized as infected.

Outcome measures

Outcome measures
Measure	Pre-operative Antibiotics n=82 Participants Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin. Cefazolin: Primary intervention Clindamycin: For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.	Saline Placebo n=78 Participants Patients randomized to the no-antibiotic group will receive a saline placebo. This placebo will consist of a 10 mL pre-filled syringe of normal saline. Saline: Placebo Intervention
Number of Participants With the Presence of Post-Operative Infection	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Three to Six Week Follow Up

Population: The VAS data was not collected and will therefore not be reported.

Presented as a 100mm horizontal line on which the patient's pain intensity is represented by a point between two extremes of "no pain at all" = 0 and "worst pain imaginable" = 100.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Three to Six Week Follow Up

Time to healing/fractures fully healed was measured by the review of AP and Lateral radiographs at the first follow-up and considered healed if at least 3 cortices had callus. This outcome measure is reported as the number of participants in each group with fully healed fractures at the designated time point.

Outcome measures

Outcome measures
Measure	Pre-operative Antibiotics n=82 Participants Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin. Cefazolin: Primary intervention Clindamycin: For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.	Saline Placebo n=78 Participants Patients randomized to the no-antibiotic group will receive a saline placebo. This placebo will consist of a 10 mL pre-filled syringe of normal saline. Saline: Placebo Intervention
Fractures Fully Healed	82 Participants	78 Participants

SECONDARY outcome

Timeframe: Three to Six Weeks Follow Up

The need for repeat casting can be due to excessive pain or loosening of the cast.

Outcome measures

Outcome measures
Measure	Pre-operative Antibiotics n=82 Participants Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin. Cefazolin: Primary intervention Clindamycin: For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.	Saline Placebo n=78 Participants Patients randomized to the no-antibiotic group will receive a saline placebo. This placebo will consist of a 10 mL pre-filled syringe of normal saline. Saline: Placebo Intervention
Number of Participants With a Need for Repeat Casting	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Three to Six Weeks Follow Up

Loss of fixation (stabilization) refers to a situation where the fixation of the fracture become compromised.

Outcome measures

Outcome measures
Measure	Pre-operative Antibiotics n=82 Participants Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin. Cefazolin: Primary intervention Clindamycin: For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.	Saline Placebo n=78 Participants Patients randomized to the no-antibiotic group will receive a saline placebo. This placebo will consist of a 10 mL pre-filled syringe of normal saline. Saline: Placebo Intervention
Number of Participants Experiencing Loss of Fixation	0 Participants	0 Participants

Adverse Events

Pre-operative Antibiotics

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pre-operative Antibiotics n=82 participants at risk Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin. Cefazolin: Primary intervention Clindamycin: For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.	Saline Placebo n=78 participants at risk Patients randomized to the no-antibiotic group will receive a saline placebo. This placebo will consist of a 10 mL pre-filled syringe of normal saline. Saline: Placebo Intervention
Musculoskeletal and connective tissue disorders Osteomyelitis	1.2% 1/82 • Number of events 1 • Approximately 6 weeks or until the fracture is healed. There is no difference in the definition of adverse event and/or serious adverse event from that of clinicaltrials.gov.	0.00% 0/78 • Approximately 6 weeks or until the fracture is healed. There is no difference in the definition of adverse event and/or serious adverse event from that of clinicaltrials.gov.

Other adverse events

Other adverse events
Measure	Pre-operative Antibiotics n=82 participants at risk Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin. Cefazolin: Primary intervention Clindamycin: For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.	Saline Placebo n=78 participants at risk Patients randomized to the no-antibiotic group will receive a saline placebo. This placebo will consist of a 10 mL pre-filled syringe of normal saline. Saline: Placebo Intervention
Skin and subcutaneous tissue disorders Infection	0.00% 0/82 • Approximately 6 weeks or until the fracture is healed. There is no difference in the definition of adverse event and/or serious adverse event from that of clinicaltrials.gov.	1.3% 1/78 • Number of events 1 • Approximately 6 weeks or until the fracture is healed. There is no difference in the definition of adverse event and/or serious adverse event from that of clinicaltrials.gov.

Additional Information

Vicki Jones

UMissouri

Phone: 573-882-7583

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place