Advancing the Standard of Care for Pin Site Care

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Open Reduction External Fixation

In brief

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.

Key facts

Study ID

NCT01965665

Run by

Duke University

People needed

20

Starts

2013-10-01

Expected to finish

2015-06-01

Last updated by the study team

2016-10-31

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center/Duke South Clinics/3J — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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