Clinical trial NCT03261830
Conditions: Supracondylar Humerus Fracture Post Operative Wound Infection
Keywords: Antibiotic Pediatric
Sponsor: Sumit Gupta
Start date: 2017-08-18; Completion date: 2023-03-10
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Detailed description:
This patient population will be recruited from the cohort presenting to Women and Children's Hospital for percutaneous fixation of pediatric supracondylar humerus fractures. Participants will be asked to assent to take part in the study and their parents or guardian will be asked to sign an informed consent. Patients will be randomized to a treatment group that receives one dose of pre-operative antibiotics or one that does not. 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. Patients randomized to the no-antibiotic group will receive a saline placebo. The resident, anesthesiologist, circulating nurse and other operating room staff will be instructed to not reveal the patient's randomization to the attending physician so as not to interfere with blinding.

The patient will then undergo closed reduction percutaneous pinning of supracondylar humerus fracture. Final AP and lateral fluoroscopic images in the case will be taken. The patient will be discharged from the hospital when pain is controlled with standard oral pain medications and all goals of inpatient management have been achieved. No patients will receive post-operative antibiotics regardless of randomization group as is the existing standard of care. Patients will be scheduled to follow up in 3-6 weeks depending on age. At that time the cast will be removed and AP and lateral radiographs will be used to assess healing. The pins will be removed in clinic and a soft dressing applied to the elbow region.

In cases of excessive pain or cast loosening the patient may be seen in clinic earlier with radiographs and physical exam as indicated. 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. If no infection is detected at an earlier-scheduled appointment the patient will be recasted and instructed to follow up as previously scheduled.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Cefazolin intervention 2: Clindamycin intervention 3: Saline
Intervention descriptions: intervention 1: Primary intervention intervention 2: For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention. intervention 3: Placebo Intervention

Protocol documents:
Prot_000.pdf: 
Antibiotics usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS) 
 
 
 
IRB Project #: 2008610 
 
PROTOCOL VERSION NUMBER: 1.1 
 
DATE: 15 SEP 2017  
 
 
 
 
 
Principal Investigator: Sumit Gupta, MD  
 
 
Co-investigators: 
Dan Hoernschemeyer, MD  
Alex Wessel, MD 
Jayson Johnson, MD 
Jimi Cook DVM, PhD 
Dana Duren, PhD  
 
 
 
 
Study Sites: University of Missouri Health System 
 
 
 
 


TABLE OF CONTENTS 
1. Background Information & Significance 
2. Objectives, Contribution, & Hypothesis  
3. Selection of Subjects 
4. Study Procedure 
5. Confidentiality of Data 
6. Assessment of Risks & Benefits  
7. References 
 
1. Background Information & Significance 
 
Supracondylar humerus fractures are some of the most common fractures in children accounting 
for 60% of all fractures around the elbow joint and approximately 3% of all fractures in children. 
Closed reduction and percutaneous pinning (CRPP) is a common treatment for displaced 
pediatric supracondylar humerus fractures (SHF).  The incidence of infection following this 
procedure is estimated to be between 0-7% (Iobst et al.).  Upon reviewing all available studies on 
infection after elbow pinning, Iobst et al. found an overall rate of infection of 2.34%. These data 
come from retrospective studies that either look at patient samples from a single or multi-center 
setting. These studies did not show significant difference in infection rates between patients that 
did or did not receive antibioitics. Usage of these preopertaive antibiotics continues to vary based 
on personal surgeon preference with no established standard of care. To our knowledge there 
have been no randomized, blinded prospective studies designed to assess the efficacy of 
preoperative antibiotics for preventing infections after CRPP of SCHFs.   
 
2. Objectives, Contribution, & Hypothesis  
Objectives: We propose to perform a prospective, randomized study to evaluate if antibiotics 
affect the outcome after percutaneous surgery for pediatric supracondylar humerus fractures. 
Contribution: We hope that this study will result in a better understanding of the need for 
antibiotics prior to percutaneous surgery for pediatric supracondylar humerus fractures.  
Hypothesis: The use of pre-operative antibiotics for percutaneous fixation of pediatric 
supracondylar humerus fractures does not affect the rate of infection.  
 
3. Selection of Subjects  
Inclusion Criteria: Age<14, open growth plates; Gartland type II and III extension type fracture, 
and flexion type fractures of the distal humerus 
Exclusion Criteria: 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, or intra-operative breech of sterile 
technique 
Sample Size: We anticipate enrolling up to 200 patients to complete the study. Sample size was 
determined based on a non-inferiority study design, and a presumed infection rate of 2.34% from 
previous literature.  
 
4. Study Procedure  
Timeline: 24-36 months of data collection 
Study Design: Prospective, randomized, double-blinded controlled study 
Protocol: This patient population will be recruited from the cohort presenting to UMHS for 
percutaneous fixation of pediatric supracondylar humerus fractures.  Participants will be asked to 
assent to take part in the study and their parents or guardian will be asked to sign an informed 
consent. Patients will be randomized to a treatment group that receives one dose of pre-operative 
antibiotics or one that does not. Randomization envelops will be created and stored in the 
operating room of the attending physicians.  Prior to the time-out procedure, the resident 
assisting with the surgery will open the top envelope and display the randomization card to the 
CRNA/Anesthesiologist. 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.  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, which is not charged 
individually to any patient, therefore, these research subjects will not be charged for this placebo. 
The resident, anesthesiologist, circulating nurse and other operating room staff will be instructed 
to not reveal the patient’s randomization to the attending physician so as not to interfere with 
blinding.  Special care will be taken to not mention preoperative antibiotic status as part of the 
normal “time-out” procedure, saying instead, “this is a study patient.” 
 
The patient will then undergo CRPP of SCHF.  The entire affected extremity will be prepped 
with chlorhexidine sponge according to manufacturer’s instructions.  The entire affected 
extremity will then be draped in the usual sterile fashion.  After manipulating the arm to achieve 
a closed reduction the fracture will be stabilized by Kirshner wires in a percutaneous fashion 
using fluoroscopy.  A soft sterile dressing will then be applied to the elbow region followed by a 
long-arm cast.  The cast may be bivalved in cases of excessive swelling.  Final AP and lateral 
fluoroscopic images in the case will be taken and sent to PACS. 
 
The patient will then be discharged from the hospital when pain is controlled with standard oral 
pain medications and all goals of inpatient management have been achieved.  No patients will 
receive post-operative antibiotics regardless of randomization group as is the existing standard of 
care. 
 
Patients will be scheduled to follow up in 3-6 weeks depending on age.  At that time the cast will 
be removed and AP and lateral radiographs will be used to assess healing.  The pins will be 


removed in clinic and a soft dressing applied to the elbow region.   
 
The primary outcome measure will be the presence of infection as judged by the blinded 
attending surgeon or nurse practitioner 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.  In cases of a deep infection cultures will be 
taken at the time of debridement and the results recorded.  Secondary outcome measures will be 
the patient’s VAS pain score at 4 weeks, time to healing, need for repeat casting and loss of 
fixation.   
 
In cases of excessive pain or cast loosening the patient may be seen in clinic earlier with 
radiographs and physical exam as indicated.  If the attending physician or nurse practitioner 
determines that a deep or superficial infection is present at any time during the treatment period 
the patient will be categorized as infected.  If no infection is detected at an earlier-scheduled 
appointment the patient will be recasted and instructed to follow up as previously scheduled.   
 
5. Confidentiality of Data 
Patient confidentiality during the course of this study will be protected in compliance with 
HIPAA requirements as well as the requirements of the University of Missouri Health-Sciences 
IRB.  
 
All subjects will be assigned a study identification number that requires the use of a key in order 
to decipher a subject’s personal identification information. The key will be kept in the Cerner 
Power Trials database, which is password protected. The study identification number will be 
used to label all paper data collection instruments.  
 
All subject information in electronic format will be kept in password-protected storage. All 
subject information in paper format will be kept in locked cabinets in a secured suite at the 
Missouri Orthopedic Institute, and otherwise will be archived in a secure storage facility, or 
destroyed.  
 
6. Assessment of Risks & Benefits 
Risks: Risks for breach of confidentiality does exist but will be limited with tight control and 
limited access to the investigators. There are risks associated with taking medications. Cefazolin 
may result in loss of appetite, nausea, vomiting, diarrhea, or headache. Clindamycin may result 
in mild nausea, vomiting, or stomach pain; joint pain; vaginal itching or discharge; mild rash or 
itching; or. heartburn, irritation in your throat.    
 
Benefits: We hope that this study will shed light on the necessity of antibiotics after percutaneous 
surgery for pediatric supracondylar humerus fractures, and decrease un-necessary medication 
use. 


 
Data Safety Monitoring Plan: The primary (infection) and secondary (VAS pain score at 4 
weeks, time to healing, need for repeat casting and loss of fixation) study endpoint data will be 
analyzed every 6 months to monitor the overall patient outcome data. The data from each 
outcome measure will be compared to those historically reported in peer-reviewed literature. 
 
7. References 
 
Schroeder et al. Utility of Postoperative Antibiotics After Percutaneous Pinning of Pediatric 
Supracondylar Humerus Fractures. JPO 2015 
Lu et al. Management of pin tract infection in pediatric supracondylar humerus fractures: a 
comparative study of three methods. Eur J Ped. 2017 
Formaini et al. Evaluating the Use of Preoperative Antibiotics in Pediatric Orthopaedic Surgery. 
JPO 2012 
Combs et al. Multicenter Study of Pin Site Infections and Skin Complications Following Pinning 
of Pediatric Supracondylar Humerus Fractures. Cereus 2016 
Bashyal et al. Complications After Pinning of Supracondylar Distal Humerus Fractures. JPO 
2009 
Iobst et al. Percutaneous Pinning of Pediatric Supracondylar Humerus Fractures With the 
Semisterile Technique The Miami Experience. JPO 2007 
Valle-Hernandex et al. Complications associated with Pediatric Supracondylar Humeral 
Fractures. P R Health Sci J 2017 
Larson et al. Operative Treatment of Type II Supracondylar Humerus Fractures: Does Time to 
Surgery Affect Complications? JPO 2014 
Fowles, Kassab. Displaced Supracondylar Fractures of the Elbow in Children. JBJS Br 1974