Advancing the Standard of Care for Pin Site Care

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965665
• Other study ID #: Pro00046972
• Status: Completed
• Phase: N/A
• First received: October 16, 2013
• Last updated: August 17, 2015
• Start date: October 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 extermity within the last 2 months based on clinical exam and/or laboratory markers

• Honey or honey based allegery

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Open Reduction External Fixation

Intervention

Device:
• MediHoney HCS dressing

Locations

Country	Name	City	State
United States	Duke University Medical Center/Duke South Clinics/3J	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total pin sites	To evaluate total pin sites.	Day of surgical intervention approximately 3hrs.	No
Primary	Change in pin site infection	Patients will be assessed weekly for pin site infection up until frame removal.	weekly from baseline until frame removal, up to 16 weeks	No
Primary	Change in Sepsis rate	Patients will be assessed weekly for sepsis or until frame is removed.	weekly from baseline until frame removal, up to 16 weeks	No
Secondary	Change in frequency of dressing changes	To see if the use of Medihoney reduces the frequency of dressing changes compared to routine standard pin site care.	weekly from baseline until frame removal, up to 16 weeks	No