Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial

Sponsor

Legacy Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT04288206

Collaborator

(none)

1,200

Enrollment

Location

Arms

34.8

Anticipated Duration (Months)

34.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, multi-center, randomized controlled trial studying infection rate with or without prophylactic antibiotics at the time of closed reduction and percutaneous pinning of pediatric supracondylar humerus fractures.

Condition or Disease	Intervention/Treatment	Phase
Supracondylar Humerus Fracture Infection	Drug: Cefazolin Drug: normal saline	N/A

Detailed Description

The goal of the SPAS trial will be to determine the role of prophylactic antibiotics in closed reduction and percutaneous fixation of pediatric supracondylar humerus fractures. The study will be designed as a prospective, double-blinded, two-arm, non-inferiority trial. The control arm will receive standard of care preoperative prophylactic antibiotics. The intervention group will receive a preoperative saline placebo. The primary outcome of the study will be the development of a surgical site infection, including all infections both superficial and deep. Secondary outcomes will include rate and type of post-operative complications in either group, to account for any drug-related adverse outcomes. The hypothesis is that this surgery is safe to perform without prophylactic antibiotics, and the investigators anticipate finding no difference in infection rates between the two groups. Inclusion criteria will consist of an isolated, closed, displaced supracondylar humerus fracture treated with closed reduction and temporary percutaneous pinning. Immunocompromised patients, pathological fractures, open fractures, polytrauma, skeletally mature patients, and those treated primarily with open reduction or those converted to open reduction will be excluded. Because of the low infection rate observed in this type of surgery, the sample size for the study is estimated at 600 patients per arm for adequate power. With a multicenter design, the expectation will be enrollment over the course of 1-2 years with a follow up of approximately 3 months post-surgical intervention per participant.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

intervention arm of intravenous cefazolin at the time of surgery (standard of care) vs placebo arm of intravenous normal saline at the time of surgeryintervention arm of intravenous cefazolin at the time of surgery (standard of care) vs placebo arm of intravenous normal saline at the time of surgery

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

'study drug' will be prepared by a participating pharmacist and labeled with a study identification number. The drug will be otherwise not labeled with regard to the arm of the study. This will be delivered to the operating room and administered to the patient. The patient will be entered into a spreadsheet with the study identification number to be used later to evaluate the data. The enrolling/consenting surgeon, and the patient and consenting family member, will be masked to the arm of the study throughout.

Primary Purpose:

Treatment

Official Title:

Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial

Actual Study Start Date :

Jan 7, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo control Patient will receive 'study drug' which is comprised of 300 mL of normal saline without any medication/antibiotic, which will be delivered by intravenous means at the time of surgery.	Drug: normal saline intravenous normal saline placebo
Active Comparator: Cefazolin prophylaxis Patient will receive 'study drug' which is comprised of weight-based dose of cefazolin mixed in 300 mL of normal saline, which will be delivered by intravenous means at the time of surgery.	Drug: Cefazolin intravenous cefazolin is being evaluated as a pre-operative prophylactic antibiotic measure with primary outcome being post operative infection rate among participants.

Arm

Intervention/Treatment

Placebo Comparator: Placebo control

Patient will receive 'study drug' which is comprised of 300 mL of normal saline without any medication/antibiotic, which will be delivered by intravenous means at the time of surgery.

Drug: normal saline

intravenous normal saline placebo

Active Comparator: Cefazolin prophylaxis

Patient will receive 'study drug' which is comprised of weight-based dose of cefazolin mixed in 300 mL of normal saline, which will be delivered by intravenous means at the time of surgery.

Drug: Cefazolin

intravenous cefazolin is being evaluated as a pre-operative prophylactic antibiotic measure with primary outcome being post operative infection rate among participants.

Outcome Measures

Primary Outcome Measures

deep post operative infection [3 months post intervention/surgery]
rate of deep post operative infections at the surgical site, requiring treatment including possible hospital admission, intravenous antibiotics, or surgical intervention
superficial post operative infection [3 months post intervention/surgery]
rate of superficial post operative infections at the surgical site, requiring treatment limited to oral antibiotics, local wound care, pin removal, or cast change/removal

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Closed, isolated extension type supracondylar humerus fracture, Gartland type 2, 3, or 4

Exclusion Criteria:

Inability to secure consent
Open fractures
Polytrauma
Pathologic fractures
Flexion type fracture
Associated compartment syndrome
Allergy to cefazolin which precludes its use
Skeletally mature patients or patients greater than 18 years of age
Medical comorbidities including immunocompromised state, active infection, and any associated bone, endocrine, or neoplastic conditions contributing to local or generalized abnormal bone mineralization.
Inability to attain satisfactory reduction and fixation via closed manipulation, resulting in conversion to open reduction