N/A Completed N=20 Treatment

Advancing the Standard of Care for Pin Site Care

Diabetes · Open Reduction External Fixation

Source: ClinicalTrials.gov NCT01965665 ↗

Enrolled (actual)

Serious AEs

5.3%

Results posted

Oct 2016

Primary outcomePrimary: Total Number of Pin Sites — 244 total number of pin sites

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Number of Pin Sites	244	—
PRIMARY Number of Patients With Pin Site Infection	3	—
PRIMARY Change in Sepsis Rate	—	—

Eligibility Criteria

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 .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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01965665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.