McMaster University researchers Mohit Bhandari and Sheila Sprague, together with Gerard Slobogean of the University of Maryland, have received funding of more than $14 million to launch a new research program in fracture management.
The Program of Randomized trials to Evaluate Pre-operative antiseptic skin solutions In orthopaedic Trauma (PREP-IT) will be a joint initiative co-ordinated by the Centre for Evidence-Based Orthopedics at McMaster University and the R Adams Cowley Shock Trauma Center at the University of Maryland.
"This funding enables a collaborative effort to improve outcomes of fracture care worldwide and further establishes our team at McMaster University as global leaders with a longstanding vision of large, innovative surgical trials," said Bhandari, professor of the Department of Surgery at the Michael G. DeGroote School of Medicine at McMaster.
"These funds, in part, will support our Global Methods Centre in the Division of Orthopedic Surgery as well as leverage critical partnerships in the Faculty of Health Sciences and abroad."
PREP-IT consists of two sister multi-centre randomized crossover trials that will compare the effect of different skin preparation solutions on the incidence of surgical site infections and unplanned fracture-related reoperations in fracture patients.
One is the Pragmatic Randomized trial Evaluating Pre-operative Alcohol skin solutions in FRactured Extremities (PREPARE) trial which has been awarded $10.9 million in funding from the U.S. Patient-Centered Outcomes Research Institute. It will recruit more than 7,800 participants with open and closed extremity fractures that are managed operatively at clinical sites in Canada and the United States. The PREPARE trial will compare the effect of pre-operative alcohol skin solutions, chlorhexidine gluconate versus iodine-povacrylex.
The second is the Pragmatic Randomized trial Evaluating Pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP) trial, which has received more than $3.2 million in funding from the United States Department of Defense, Physicians' Services Incorporated Foundation and McMaster Surgical Associates. It will recruit more than 1,500 participants with open extremity fractures treated operatively at clinical sites in Canada and the United States. The Aqueous-PREP trial will compare the effect of aqueous pre-operative antiseptic skin preparation with 10 per cent povidone-iodine versus 4 per cent chlorhexidine gluconate.
"Infections are often devastating complications for open fracture patients because of the resultant reoperations, adverse events resulting from antibiotic administration and fracture healing difficulties," said Sprague, assistant professor in the Department of Surgery.
"Given the severity of open fractures, maximizing the effectiveness of current prophylactic procedures is essential. This research program will provide necessary evidence to guide the prevention infections in open fractures, and these trials are poised to have a significant impact on the care and outcomes of open extremity fracture patients."
A number of McMaster researchers and faculty members will be involved in the PREP-IT initiative. Among this group are researchers including Gordon Guyatt, P.J. Devereaux and Lehana Thabane. More than 20 hospitals across North America will participate in the two trials.