Post Operative Wound Infection, Supracondylar Humerus Fracture
Conditions
Keywords
Antibiotic, Pediatric
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.
Interventions
DRUGCefazolin
Primary intervention
DRUGClindamycin
For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.
DRUGSaline
Placebo Intervention
Sponsors
University of Missouri-Columbia
Sumit Gupta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Randomization envelops will be created. Attending surgeons/Investigators will be blinded. Participant will be blinded.
Intervention model description
Patients will be randomized in that one group receives one dose of pre-operative antibiotics or one that does not.
Eligibility
Sex/Gender
ALL
Age
No minimum to 13 Years
Healthy volunteers
No
Inclusion criteria
* 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
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 * Intra-operative breech of sterile technique
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Presence of Post-Operative Infection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Scale | Three to Six Week Follow Up | 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. |
| Fractures Fully Healed | 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. |
| Number of Participants With a Need for Repeat Casting | Three to Six Weeks Follow Up | The need for repeat casting can be due to excessive pain or loosening of the cast. |
| Number of Participants Experiencing Loss of Fixation | Three to Six Weeks Follow Up | Loss of fixation (stabilization) refers to a situation where the fixation of the fracture become compromised. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 82 |
| 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 | 78 |
| Total | 160 |
Baseline characteristics
| Characteristic | Pre-operative Antibiotics | Saline Placebo | Total |
|---|---|---|---|
| Age, Continuous | 5.9 Years | 5.5 Years | 5.67 Years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 40 Participants | 47 Participants | 87 Participants |
| Sex: Female, Male Male | 42 Participants | 31 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 78 |
| other Total, other adverse events | 0 / 82 | 1 / 78 |
| serious Total, serious adverse events | 1 / 82 | 0 / 78 |
Outcome results
Primary
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.
Time frame: Six weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-operative Antibiotics | Number of Participants With the Presence of Post-Operative Infection | 2 Participants |
| Saline Placebo | Number of Participants With the Presence of Post-Operative Infection | 2 Participants |
Secondary
Fractures Fully Healed
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.
Time frame: Three to Six Week Follow Up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-operative Antibiotics | Fractures Fully Healed | 82 Participants |
| Saline Placebo | Fractures Fully Healed | 78 Participants |
Secondary
Number of Participants Experiencing Loss of Fixation
Loss of fixation (stabilization) refers to a situation where the fixation of the fracture become compromised.
Time frame: Three to Six Weeks Follow Up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-operative Antibiotics | Number of Participants Experiencing Loss of Fixation | 0 Participants |
| Saline Placebo | Number of Participants Experiencing Loss of Fixation | 0 Participants |
Secondary
Number of Participants With a Need for Repeat Casting
The need for repeat casting can be due to excessive pain or loosening of the cast.
Time frame: Three to Six Weeks Follow Up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-operative Antibiotics | Number of Participants With a Need for Repeat Casting | 0 Participants |
| Saline Placebo | Number of Participants With a Need for Repeat Casting | 0 Participants |
Secondary
Visual Analog Pain Scale
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.
Time frame: Three to Six Week Follow Up
Population: The VAS data was not collected and will therefore not be reported.