Advancing the Standard of Care for Pin Site Care

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Open Reduction External Fixation
• Interventions: Device: MediHoney HCS dressing

• Registration Number: NCT01965665
• Lead Sponsor: Duke University

Brief 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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-18
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-06
• Results First Submitted: 2016-06-09
• Results First Submitted QC: 2016-09-13
• Last Update Submitted: 2016-09-13
• Results First Posted: 2016-10-31
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medihoney HCS dressing	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.

Primary Outcome Measures

Name	Time	Method
Total Number of Pin Sites	Day of surgical intervention approximately 3hrs.	total number of pin sites for all patients enrolled
Number of Patients With Pin Site Infection	weekly from baseline until frame removal, up to 16 weeks	Patients will be assessed weekly for pin site infection up until frame removal.
Change in Sepsis Rate	weekly from baseline until frame removal, up to 16 weeks	Patients will be assessed weekly for sepsis or until frame is removed.

Trial Locations

Locations (1)

Duke University Medical Center/Duke South Clinics/3J; 🇺🇸 Durham, North Carolina, United States