Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery

NCT01798810 | Completed DMC

• 1 other identifier: W81XWH-12-1-0588
• Study Type: interventional
• Target: 1,171
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Operative Surgical Site Infection

Keywords

Surgical Site Infection Risk Prediction; Bacterial species type and antibacterial sensitivities; Resource Utilization and Cost

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  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).

  26 weeks

Secondary Outcomes (3)

• Catalog and Compare Bacterial Species

  26 weeks

• Risk Factors for Infection

  26 weeks

• Resource Utilization and Cost

  1 year

Study Arms (2)

Supplemental Perioperative Oxygen (80% FiO2)

EXPERIMENTAL

After intubation, patients in the Treatment Group will receive intraoperative inspired oxygen set at 80 percent (FiO2 of 0.80). Post-extubation, patients in the treatment arm will be placed on high flow non-re-breather mask at 15L/min for up to 2 hours postoperatively and then transitioned to nasal cannula, which will be weaned as tolerated.

Procedure: Supplemental Perioperative Oxygen

Control (30% FiO2)

NO INTERVENTION

After intubation, patients in the control arm will receive typical standard of care intraoperative inspired oxygen of 30 percent (FiO2 of 0.30). Post-extubation, patients in the control arm of the study will be placed on a nasal cannula at 4L/min to maintain SaO2≥92% as determined by pulse oximetry. This will be maintained for up to 2 hours and then weaned as tolerated.

Interventions

Supplemental Perioperative Oxygen PROCEDURE

Patients receiving perioperative oxygen will receive 80% FiO2 during surgery.

Supplemental Perioperative Oxygen (80% FiO2)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead

Study Sites (2)

Banner University Medical Center/The CORE Institute

Phoenix, Arizona, 85023, United States

Location

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Renan Castillo, PhD

  Johns Hopkins Bloomberg School of Public Health

  STUDY DIRECTOR

• Robert O'Toole, MD

  University of Maryland R Adams Cowley Shock Trauma Center

  PRINCIPAL INVESTIGATOR

• Anthony Carlini, MS

  Johns Hopkins Bloomberg School of Public Health

  STUDY DIRECTOR

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: SPONSOR

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 26, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2019
• Study Completion: June 30, 2022
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (2)