Advancing the Standard of Care for Pin Site Care

Duke University

Status: Completed

Conditions: Diabetes Mellitus; Open Reduction External Fixation

Treatments: Device: MediHoney HCS dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT01965665

Pro00046972

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Medihoney HCS dressing

Experimental group

Description:

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

Treatment:

Device: MediHoney HCS dressing