Antibiotic Prophylaxis in Orthopaedic Traumatology

NCT00610987 | Completed Results

• 1 other identifier: IRB1089017
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

It has been established that providing antibiotic prophylaxis after closed fracture fixation with implants or prosthetic devices has beneficial effects. However, the optimal duration of antibiotic prophylaxis after orthopaedic trauma surgery is not well-defined. Most studies comparing single-dose prophylaxis with multiple-dose prophylaxis have not shown beneficial effects of additional doses. Our proposed study is intended to further define the appropriate duration of antibiotic (cefazolin) administration for surgical prophylaxis in the treatment of closed fractures. We will randomly assigned patients into two groups, hopefully differentiated only by the duration of antibiotic administration (single dose vs. 24 hours). We will follow these patients until fracture healing and determine if there is a difference in the incidence of infection.

Conditions

Fractures, Closed; Wounds and Injuries

Keywords

Antibiotic Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Total Wound Infections

  The primary endpoint was infection.

  at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs.

Study Arms (2)

Cefazolin

ACTIVE COMPARATOR

Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.

Drug: cefazolin

Placebo

PLACEBO COMPARATOR

Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin

Drug: Placebo

Interventions

cefazolin DRUG

Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours.

Also known as: cefazolin brand name = Kefzol

Cefazolin

Placebo DRUG

Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older;
• Scheduled for primary osteosynthesis or placement of a prosthetic device in the treatment of closed limb fractures;
• Ability to give informed consent.

You may not qualify if:

• Known hypersensitivity to cephalosporins;
• Antimicrobial use or symptoms of infection in the week before surgery;
• Pregnancy;
• Immunosuppressive treatment;
• Inability to give informed consent.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Fractures, Closed; Wounds and Injuries

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Fractures, Bone

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Brett Crist
• Organization: University of Missouri, Department of Orthopaedics

cristb@health.missouri.edu

573-882-6562

Study Officials

• Brett D Crist, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Co-Director of Trauma Services, Co-Director Trauma Fellowship, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 8, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 12, 2015
• Results First Posted: June 12, 2015

Record last verified: 2015-05

Locations

US (1)