Supracondylar Humerus FracturePhase 4NCT03261830
Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)
A Phase 4 study testing Cefazolin, Clindamycin and Saline in people with Supracondylar Humerus Fracture and Post Operative Wound Infection, run by Sumit Gupta at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 13 years
- Conditions the study is for
- Supracondylar Humerus Fracture, Post Operative Wound Infection
- What is being tested?
- Cefazolin, Clindamycin and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2017to 10 Mar 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Health System
Columbia, Missouri, 65212
About this study
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.
Read the 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.
- Being tested
- Cefazolin, Clindamycin, Saline
- Keywords
- Antibiotic, Pediatric
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Primary intervention
ClindamycinDrug
For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.
SalineDrug
Placebo Intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six weeks
Secondary outcomes (4)
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.
Measured: Three to Six Week Follow Up
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.
Measured: Three to Six Week Follow Up
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.
Measured: Three to Six Weeks Follow Up
Number of Participants Experiencing Loss of Fixation
Loss of fixation (stabilization) refers to a situation where the fixation of the fracture become compromised.
Measured: Three to Six Weeks Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start18 Aug 2017
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supracondylar Humerus FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in that one group receives one dose of pre-operative antibiotics or one that does not.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumit Gupta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri-Columbia
- Responsible party
- Sponsor-investigator, Sumit Gupta, University of Missouri-Columbia
- Investigators
- Sumit Gupta, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261830
- Sponsor's protocol ID
- 2008610
- Status last verified
- Jul 2024
- First submitted
- 23 Aug 2017
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 38422496
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)
- ClinicalTrials.gov ID
- NCT03261830
- Acronym / sponsor ID
- 2008610
- Keywords
- Antibiotic, Pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Sumit GuptaUniversity, hospital or other
- Collaborators
- University of Missouri-Columbia
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized in that one group receives one dose of pre-operative antibiotics or one that does not.
| Arm | Type | Receives |
|---|---|---|
| Pre-operative Antibiotics | Active comparator | Drug: Cefazolin, Drug: ClindamycinPatients 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. |
| Saline Placebo | Placebo comparator | Drug: SalinePatients 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. |
Who may qualify
- Ages
- Up to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefazolinPrimary intervention | Drug | Pre-operative Antibiotics |
| ClindamycinFor use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention. | Drug | Pre-operative Antibiotics |
| SalinePlacebo Intervention | Drug | Saline Placebo |
Primary outcome
Number of Participants With the Presence of Post-Operative Infection
Time frame: 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.
4 secondary outcomes
Visual Analog Pain Scale
Time frame: Three to Six Week Follow Up
Fractures Fully Healed
Time frame: Three to Six Week Follow Up
Number of Participants With a Need for Repeat Casting
Time frame: Three to Six Weeks Follow Up
Number of Participants Experiencing Loss of Fixation
Time frame: Three to Six Weeks Follow Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38422496Gupta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumit Gupta, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefazolin, Clindamycin and Saline in people with Supracondylar Humerus Fracture and Post Operative Wound Infection, run by Sumit Gupta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With the Presence of Post-Operative Infection (time frame: Six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03261830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.