Advancing the Standard of Care for Pin Site Care

September 13, 2016 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center/Duke South Clinics/3J

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: MediHoney HCS dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Pin Sites
Time Frame: Day of surgical intervention approximately 3hrs.
total number of pin sites for all patients enrolled
Day of surgical intervention approximately 3hrs.
Number of Patients With Pin Site Infection
Time Frame: weekly from baseline until frame removal, up to 16 weeks
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
Time Frame: weekly from baseline until frame removal, up to 16 weeks
Patients will be assessed weekly for sepsis or until frame is removed.
weekly from baseline until frame removal, up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Michael Kerzner, DPM, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 18, 2013

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00046972

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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