NCT03380273

AO Multicenter Intervention Trial for Prevention of Surgical Site Infection

AO Multicenter Intervention Trial to Evaluate the Impact of a Bundle of Measures for the Prevention of Surgical Site Infection in Fracture Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to collect data from 8,476 fracture patients during a pre-and post-intervention phases of two years length each. The intervention consists on the implementation of the AOT SSI Prevention Bundle. D

Detailed 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 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).

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
BEHAVIORAL	Implementation of the AO Trauma SSI Prevention Bundle	AOT SSI Prevention Bundle Preventive measure 1. Antibiotic prophylaxis 2. Perioperative antibiotics 3. Oxygen administration 4. Patient temperature 5. Surgeon protective wear 6. Patient operative skin preparation 7. Suction drains 8. Blood glucose level 9. Red cell transfusion 10. Dressing changes

Timeline

• Start date: 2019-12-06
• Primary completion: 2021-12-30
• Completion: 2021-12-31
• First posted: 2017-12-21
• Last updated: 2022-01-18

Locations

14 sites across 6 countries: United States, Argentina, Germany, Romania, South Korea, Spain