The purpose of this study is to prospectively evaluate the effect of Active Leptospermum honey utilizing the MediHoney HCS dressing, on the occurrence of PIN site infections, and also to see if the use of MediHoney HCS reduces the frequency of dressing changes compared to published reports of routine standard pin site care.
Up to 20 Diabetic Mellitus patients undergoing Open Reduction External Fixation (OREF) for foot and/or ankle fusions, fracture repair, or osteotomy will be enrolled to receive weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. No procedures, tests or interventions will be performed exclusively for research purposes or more frequently than the standard of care. Upon completion of the study, pin sites sepsis rates will be compared to published reports for standard pin site care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Duke University Medical Center/Duke South Clinics/3J
Durham, North Carolina, United States
Total Number of Pin Sites
total number of pin sites for all patients enrolled
Time frame: Day of surgical intervention approximately 3hrs.
Number of Patients With Pin Site Infection
Patients will be assessed weekly for pin site infection up until frame removal.
Time frame: weekly from baseline until frame removal, up to 16 weeks
Change in Sepsis Rate
Patients will be assessed weekly for sepsis or until frame is removed.
Time frame: weekly from baseline until frame removal, up to 16 weeks
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