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OpenTrials
Completed

NCT Number: NCT01965665

Advancing the Standard of Care for Pin Site Care

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Open Reduction External Fixation

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center/Duke South Clinics/3J

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MediHoney HCS dressing

Device

Primary outcomes

  1. Total Number of Pin Sites

    Time frame: Day of surgical intervention approximately 3hrs.

    total number of pin sites for all patients enrolled

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Advancing the Standard of Care for Pin Site Care: Prospective Single Center Study Using Medihoney HCS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2013
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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