Clinical trial NCT01798810: Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery
Official title: Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery (OXYGEN Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Surgical Site Infection
Keywords: Surgical Site Infection Risk Prediction
Bacterial species type and antibacterial sensitivities
Resource Utilization and Cost
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Patients may have co-existing infection not at study fracture site, with or without antibiotic treatment.
* Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
* Patients may have a head injury.
* Patients may be treated initially with a temporary external fixator prior to randomization.
* Patients may have a portion of the fixation (e.g. fibula fixation in pilon or percutaneous screws across a tibial plateau fracture) prior to definitive plate fixation, at any initial surgery before randomization for definitive fixation.
* Patients may have other orthopedic and non-orthopaedic injuries.
* Patients may have pre-existing musculoskeletal injuries, be non ambulators, or have spinal cord injuries.

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.

Primary outcomes:
measure: Surgical Site Infection
timeFrame: 26 weeks
Secondary outcomes:
measure: Catalog and Compare Bacterial Species
timeFrame: 26 weeks
measure: Risk Factors for Infection
timeFrame: 26 weeks
measure: Resource Utilization and Cost
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center/The CORE Institute
state: Arizona
city: Baltimore
country: United States
facility: University of Maryland R Adams Cowley Shock Trauma Center
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Renan Castillo, PhD
role: STUDY_DIRECTOR
affiliation: University of Maryland R Adams Cowley Shock Trauma Center
name: Robert O'Toole, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Anthony Carlini, MS
role: STUDY_DIRECTOR
References: