Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)

NCT03261830 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2008610
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine if antibiotics affect the outcome after percutaneous surgery for pediatric supracondylar humerus fractures. The patient population will be recruited from the cohort presenting to Women and Children's Hospital for percutaneous fixation of pediatric supracondylar humerus fractures who meet the eligibility criteria and consent to taking part in the study. Patients will be followed up for 3-6 weeks depending on age, and will be evaluated on the presence or absence superficial or deep infection, Visual Analog Scale pain scores, time to healing, need for repeat casting, and loss of fixation.

Conditions

Supracondylar Humerus Fracture; Post Operative Wound Infection

Keywords

Antibiotic; Pediatric

Outcome Measures

Primary Outcomes (1)

• Number of Participants With the Presence of Post-Operative Infection

  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.

  Six weeks

Secondary Outcomes (4)

• Visual Analog Pain Scale

  Three to Six Week Follow Up

• Fractures Fully Healed

  Three to Six Week Follow Up

• Number of Participants With a Need for Repeat Casting

  Three to Six Weeks Follow Up

• Number of Participants Experiencing Loss of Fixation

  Three to Six Weeks Follow Up

Study Arms (2)

Pre-operative Antibiotics

ACTIVE COMPARATOR

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.

Drug: Cefazolin; Drug: Clindamycin

Saline Placebo

PLACEBO COMPARATOR

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.

Drug: Saline

Interventions

Cefazolin DRUG

Primary intervention

Pre-operative Antibiotics

Clindamycin DRUG

For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.

Pre-operative Antibiotics

Saline DRUG

Placebo Intervention

Saline Placebo

Eligibility Criteria

• Age: Up to 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age\<14 years
• Open growth plates
• Gartland type II or III extension type fracture of the distal humerus OR Flexion type fracture of the distal humerus

You may not qualify if:

• Need for open reduction
• Need for antibiotics due to other injuries or conditions during the entire study period
• Immunosuppression
• History of malignancy or metabolic bone disease
• Open fractures
• Pre-existing Infection
• Intra-operative breech of sterile technique

Sponsors & Collaborators

• Sumit Gupta: lead
• University of Missouri-Columbia: collaborator

Study Sites (1)

University of Missouri Health System

Columbia, Missouri, 65212, United States

Location

Related Publications (1)

• Gupta SK, Esposito ER, Phillips R, Schwab PE, Leary EV, Hoernschemeyer DG. Effect of Antibiotic Prophylaxis on Infection Rates in Pediatric Supracondylar Humerus Fractures Treated with Closed Reduction and Percutaneous Pinning: A Prospective Double-Blinded Randomized Controlled Trial. J Am Acad Orthop Surg. 2024 May 1;32(9):410-416. doi: 10.5435/JAAOS-D-23-00795. Epub 2024 Feb 28.

  PMID: 38422496 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefazolin; Clindamycin; Sodium Chloride

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Vicki Jones
• Organization: UMissouri

jonesvicki@health.missouri.edu

573-882-7583

Study Officials

• Sumit Gupta, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization envelops will be created. Attending surgeons/Investigators will be blinded. Participant will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Assistant Clinical - Department of Orthopaedic Surgery

Model Details: Patients will be randomized in that one group receives one dose of pre-operative antibiotics or one that does not.

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: August 18, 2017
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-07

Locations

US (1)