Accession Number:

AD1007200

Title:

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

Descriptive Note:

Technical Report,30 Sep 2014,29 Sep 2015

Corporate Author:

University of Maryland, Baltimore Baltimore United States

Personal Author(s):

Report Date:

2015-10-01

Pagination or Media Count:

23.0

Abstract:

Our study is a multi-center prospective randomized treatment trial investigating if supplemental perioperative oxygen use will reduce surgical site infection after surgery on fractures with a high risk of infection. The study utilizes the DOD-funded Major Extremity Research Consortium METRC. The study population is calcaneus, pilon, and tibial plateau fractures. During the first year we created a protocol committee, designed and approved the protocol and CRFs, obtained IRB approval. We have enrolled 427 patients to date at 18 centers. We have now reached a steady state of greater than 20 patients per month 278 this year. Follow up rate has been strong with 93 percent at 3 months and 86 percent at 6 months. The study is on track to complete enrollment in a reasonable time frame and there are no barriers to study completion.

Subject Categories:

Distribution Statement:

APPROVED FOR PUBLIC RELEASE