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Advancing the Standard of Care for Pin Site Care

NCT ID: NCT01965665

Last Updated: 2016-10-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-06-30

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.

Conditions

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Diabetes Mellitus Open Reduction External Fixation

Keywords

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Diabetes Surgical Intervention Honey

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medihoney HCS dressing

weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.

Group Type EXPERIMENTAL

MediHoney HCS dressing

Intervention Type DEVICE

Interventions

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MediHoney HCS dressing

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Kerzner, DPM

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center/Duke South Clinics/3J

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00046972

Identifier Type: -

Identifier Source: org_study_id