Advancing the Standard of Care for Pin Site Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Advancing the Standard of Care for Pin Site Care: Prospective Single Center Study Using Medihoney HCS

Conditions
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Diabetes Mellitus, Open Reduction External Fixation

Intervention / Treatment
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* Device: MediHoney HCS dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A signed and dated informed consent has been obtained from the subject. Subject is able and willing to comply with study procedures. Subject is 18 years of age or older. Type I or II Diabetes Albumin >2.5 A1C<12 or average fasting levels <200 ABI > .6 or biphasic pedal vessels by Doppler Charcot arthropathy of lower extremity Foot/ankle deformity Foot/ankle fracture Subject will undergo an Open Reduction with External Fixation (OREF). Exclusion Criteria: A1C > 12 ABI < .6 or monophasic pedal pulses on Doppler Recent (<2 months) or ongoing bone infection based on radiograph or scan Cellulitis of lower extremity within the last 2 months based on clinical exam and/or laboratory markers Honey or honey based allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medihoney HCS dressing<br>weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. | Device: MediHoney HCS dressing<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Pin Sites | total number of pin sites for all patients enrolled | 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. | 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. | weekly from baseline until frame removal, up to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Surgical Intervention, Honey