Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery (OXYGEN Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post Operative Surgical Site Infection
- Sponsor
- Major Extremity Trauma Research Consortium
- Enrollment
- 1000
- Locations
- 2
- Primary Endpoint
- Surgical Site Infection
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The OXYGEN Study is a double blinded prospective randomized controlled trial that will compare the proportion of surgical site infections within 6 months in patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
Detailed Description
Primary Objective To compare the proportion of surgical site infections within 6 months in patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen. Secondary Objectives To compare species and antibacterial sensitivities of the bacteria in the patients who develop surgical site infections in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen. To validate the previously developed risk prediction model for the development of surgical site infections after fracture surgery To measure and compare resource utilization and cost associated with surgical site infection in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen. Primary Aim: To compare the proportion of surgical site infections within 6 months in patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen. Hypothesis 1: The proportion of surgical site infections will be lower for patients treated with Supplemental Perioperative Oxygen. Secondary Aim #1: Compare bacterial species and antimicrobial susceptibilities in the patients who develop surgical site infections in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen. Hypothesis 2: In the patients who develop infections, the bacterial species and antimicrobial susceptibility profiles of those treated with Supplemental Perioperative Oxygen will be similar to those treated without Supplemental Perioperative Oxygen. Secondary Aim #2: To validate the previously developed risk prediction model for the development of surgical site infections after fracture surgery. Hypothesis 3: The previously developed RIOTS score will be highly predictive of infection risk. Secondary Aim #3: Measure and compare resource utilization and cost associated with surgical site infection in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen. Hypothesis 4: Supplemental Perioperative Oxygen will be associated with lower resource utilization and cost.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All "high energy" tibial plateau fractures treated operatively with plate and screw fixation. We define "high energy" tibial plateau fractures as patients who are either:
- •Initially treated with an external fixation and treated more than 7 days later after swelling has resolved.
- •Gustilo Type I, II, and IIIA open fracture, regardless of timing of definitive treatment.
- •All "high energy" pilon (distal tibial plafond) fractures treated operatively with plate and screw fixation. We define "high energy" tibial plateau fractures as patients who are either:
- •Initially treated with an external fixation (with or without fibula fixation or limited internal fixation) and treated definitively more than 7 days later after swelling has resolved.
- •Gustilo Type I, II, and IIIA open fracture, regardless of timing of definitive treatment.
- •All "high energy" calcaneus fractures treated operatively with plate and screw fixation in a staged fashion. We define "high energy" calcaneus fractures as patients who are either:
- •Treated definitively more than 7 days later after swelling has resolved.
- •Gustilo Type Type I, II, and IIIA \[30,31\] open fracture, regardless of timing of definitive treatment.
- •Ages 18 to 80 years
Exclusion Criteria
- •Tibial plateau, pilon, or calcaneus already infected at time of study enrollment.
- •Type IIIB, or IIIC open \[30,31\] fractures
- •Patient speaks neither English nor Spanish.
- •Transfer patients who have already had definitive fixation.
- •Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury or those how are intellectually challenged without adequate family support).
- •Patients who are intubated at the time of consent.
- •Patients whose oxygen requirements at the time of surgery would prevent them from participating in either study group will be excluded.
- •History of COPD or any other chronic respiratory disease that renders the patient oxygen dependent at baseline.
- •Current or history of Bleomycin use (chemotherapy use associated with oxygen toxicity).
- •Patient is currently pregnant.
Outcomes
Primary Outcomes
Surgical Site Infection
Time Frame: 26 weeks
The main outcome measure will be the presence of clinically significant surgical site infection (SSI) in the first 26 weeks after surgery, as determined by CDC guidelines. Wound characteristics will also be evaluated using the ASEPSIS score. In this system wounds are scored using the weighted sum of points assigned for predetermined criteria including the need for Additional treatment, presence of Serous drainage, Erythema, Purulent exudates, Separation of deep tissues, the Isolation of bacteria, and the duration of patients Stay (ASEPSIS).
Secondary Outcomes
- Catalog and Compare Bacterial Species(26 weeks)
- Risk Factors for Infection(26 weeks)
- Resource Utilization and Cost(1 year)