Advancing the Standard of Care for Pin Site Care
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 95 |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | June 2015 |
Advancing the Standard of Care for Pin Site Care: Prospective Single Center Study Using Medihoney HCS
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.
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.
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.
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 extermity within the last 2 months based on clinical exam and/or
laboratory markers
- Honey or honey based allegery
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