[img_inline align=”right” src=”http://padnws01.mcmaster.ca/images/Bhandari_Mohit.jpg” caption=”Dr. Mohit Bhandari, orthopedic surgeon and assistant professor of surgery. File photo.”]When broken bones pierce the skin, the chance of infection is a doctor's number one concern.

McMaster University researchers have a hunch something as simple, and cheap, as mild soap could do a better job of preventing infection than the decades-old practice of flushing dirt out of a wound with saline.

They are testing their theory in an international pilot study called FLOW (Fluid Lavage of Open Wounds) of 100 patients. If the researchers' theory holds, a multi-national study of 1,200 patients will be undertaken to confirm the findings.

For decades, surgeons have searched for better ways of cleansing wounds to cut the rate of infection which, in serious cases, may lead to the amputation of a limb.

In the past, they have tried saline alone, saline and antibiotics, strong alcohol-based products and iodine. They found iodine and alcohol-based products, for example, did more harm than good. Adding antibiotics to saline was found to be no better than saline alone.

Ten years ago, researchers started to experiment with mild castile soap. A recent study found soap reduced the risk of major infection by 25 per cent when it was compared to a standard saline plus antibiotic solution. However, the study had too few patients to prove its effectiveness in reducing infection.

The McMaster researchers decided to take on this project and come up with a definitive answer. Their survey of 1,000 surgeons around the world found 94 per cent would welcome a definitive answer and would participate in a randomized trial to prove it.

Orthopedic surgeon Dr. Mohit Bhandari, assistant professor of surgery at McMaster University and the study's principal investigator, said the results could have a global impact, particularly in countries such as India, China and Africa where injuries are common and inexpensive, effective treatments are difficult to access.

Currently, 80 of the 100 patients required for the first analysis have been recruited from six centers in Hamilton, Ottawa, Halifax, South Carolina, Texas and India. Patients are being randomized to receive standard care — a normal saline wash-out of their wound — or a soap solution which has been added to saline. Results are expected this fall.

In Canada, roughly 30,500 people annually suffer open fractures with a major break in the skin, leaving them at risk of infection. Another 250,000 people in the United States are susceptible to infection after breaking bones. Ten times these numbers arrive in hospital emergency departments needing treatment for major cuts and skin breaks. Globally, staggering numbers of people suffer wounds that are poorly treated.

Researchers received $170,000 in funding support for the pilot study from the Orthopedic Trauma Association, Canadian Orthopedic Foundation and Physician Services Incorporated.

They are working in partnership with Zimmer Canada, a Mississauga-based company which is a world leader in the orthopedic industry. The company is providing the study with the irrigation device used to cleanse wounds.

“We are also working closely with Zimmer to develop a novel irrigation device that delivers soap to open wounds and provides lots of suds,” Bhandari said.

The device would cost a few dollars, not hundreds, he said. “The goal is to make something that is affordable and accessible.”

Positive results could also change the standard of care for Canadian soldiers serving in Afghanistan where infections from gunshot wounds, and other serious injuries, are an on-going problem.

During a stint in Afghanistan earlier this year, Toronto orthopedic trauma surgeon Dr. Michael McKee witnessed first-hand the need for a simple, cost-effective means for cleansing wounds as soon as possible after soldiers are injured.

Yet, the medical literature is unclear about what solution best prevents infections, said McKee who is on staff at St. Michael's Hospital, an associate professor at the University of Toronto and one of the soap study's investigators.

The hope, McKee said, is that the study will provide definitive information about what should go in the solution, and how it should be applied, and ultimately, become a simple, cost-effective means of treating open fractures in developing countries.

“It would definitely make a difference for Coalition forces injured in places like Afghanistan and Iraq.”

How well soldiers ultimately recover from war-inflicted injuries depends on the initial cleansing of their wounds, said McKee.

“If soldiers come back from Afghanistan with a limb aligned and a clean wound, then there are multiple options for them and their prognosis is good,” he said. “But, if they come back with dirt, or bacteria in the wound, or active impending infection, the number of options they have immediately becomes dramatically restricted and their prognosis is poor.”

The pilot study is co-ordinated by the CLARITY (Clinical Advances through Research and Information Translation) Group at McMaster University. In addition to Dr. Bhandari, researchers include orthopedic surgeon Dr. Brad Petrisor and study co-ordinators Sheila Sprague and Tashay Mignott.