On January 20, 2007, the ACFAS Research/EBM Committee selected the study Bacterial Skin Contamination prior to and after Surgical Preparation of the Foot, Ankle, and Lower Leg in Patients with Diabetes and Ulceration: A Prospective Controlled Therapeutic Study as the recipient of the 2006 Clinical and Scientific Research Award, awarding its investigators $15,226.41.

Bacterial Skin Contamination prior to and after Surgical Preparation of the Foot, Ankle, and Lower Leg in Patients with Diabetes and Ulceration: A Prospective Controlled Therapeutic Study

Principal Investigator:  Monica Schweinberger, DPM, AACFAS
Co-Investigators: Thomas S. Roukis, DPM, FACFAS; Charles Andersen, MD, FACS; and Adam S. Landsman, DPM, PhD, FACFAS 

Project Summary: The foot is a frequent location of bacterial contamination (1-3) and the development of a post-operative infection after foot and ankle surgery is considered a serious concern (4-6).  Unfortunately, eradication of bacterial flora from the foot, especially the nailfolds and toe webspaces, through surgical preparation remains a challenge (3, 7-13). All of the studies to date have involved either healthy patients undergoing elective foot and ankle surgery or young healthy volunteers (3, 7-13).  However, the patient with diabetes is considered an immuno-compromised host with decreased ability to combat invasive bacterial infections (14, 15). The use of an efficacious surgical preparation is therefore of paramount importance. The authors will conduct a prospective study involving patients with diabetes with and without ulceration who will undergo the current “best evidence available” surgical preparation (i.e., chlorhexidine gluconate scrub followed by alcohol impregnated with iodine solution which has been determined from detailed literature review and a small safety related observational pilot study conducted by the authors to be efficacious and safe, respectively). Qualitative aerobic cultures prior to and after completion of this surgical preparation technique will be obtained from the hallux nailfold, second, third, and fourth toe webspaces (as one culture), and anterior tibia (control group). From each culture site the type of bacterial flora present and sensitivity will be determined.  Additionally, the reduction in bacterial flora following surgical preparation as described in the material and methods for both patient groups will be analyzed.

The information obtained from the study will provide podiatric foot and ankle surgeons with evidence regarding the types of bacterial flora present prior to and following surgical preparation, as well as, sensitivities for patients with diabetes with and without ulceration. Results for this study will potentially improve the care of patients with diabetes undergoing foot and ankle surgery by: (1) supporting or refuting the efficacy of the surgical preparation technique advocated by the “best available evidence”; providing information for home foot hygiene programs which are currently lacking evidence (16-18); (3) and directing local wound care modalities to target the actual organisms present in these specific clinical scenarios rather than relying on information from strictly healthy patient populations (3, 7-13), or theory alone.  This is especially important with the increasing discussion of prophylactic surgical intervention performed on the foot and ankle in the diabetic patient population with and without ulceration (19, 20).

Level of Evidence: 2B