AO Multicenter Intervention Trial for Prevention of Surgical Site Infection
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Surgical Site Infection
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: During two years, patients with fractures are recorded and the occurence of surgical site infections (SSI) in these patients is monitored in different sites over the world. After two years, a bundle of known prevention measures are teached and enforced in these sites. Then the occurence of SSI in fracture patients is monitored for another two years to see whether the bundle decreased the SSI occurence.Masking: None (Open Label)Masking Description: It is that preventino measures are enforced in the hospital. This will apply to all patients and no masking is required.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 100 years
- Gender
- Both males and females
Description
During the first phase of the study, 4,238 patients will be recruited and the baseline incidence of surgical site infection at each participating site will be determined. At the beginning of the third year, the bundle will be implemented and data on 4,238 additional patients will be collected. The i...
During the first phase of the study, 4,238 patients will be recruited and the baseline incidence of surgical site infection at each participating site will be determined. At the beginning of the third year, the bundle will be implemented and data on 4,238 additional patients will be collected. The incidence rate on surgical site infection before and after the intervention will be compared. We hypothesize that this intervention will reduce the infection rate within the first 3 months after surgery from 6% to 4.5% (5% to 3.75% in closed fractures and from 10% to 7.5% in open fractures).
Tracking Information
- NCT #
- NCT03380273
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Stephen Kates, MD VCU Health
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