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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medihoney HCS dressing | Experimental | weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MediHoney HCS dressing | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Pin Sites | total number of pin sites for all patients enrolled | Day of surgical intervention approximately 3hrs. |
| Number of Patients With 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 |
| 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 |
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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
Subject will undergo an Open Reduction with External Fixation (OREF).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kerzner, DPM | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center/Duke South Clinics/3J | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. MediHoney HCS dressing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. MediHoney HCS dressing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Pin Sites | total number of pin sites for all patients enrolled | Posted | Number | total number of pin sites | Day of surgical intervention approximately 3hrs. |
|
|
baseline until frame removal, up to 16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. MediHoney HCS dressing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI infection | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| osteotomy site infection (not pin site) | Injury, poisoning and procedural complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Kerzner, DMP | Duke University Medical Center | 919-613-4449 | michael.kerzner@duke.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Number of Patients With Pin Site Infection | Patients will be assessed weekly for pin site infection up until frame removal. | Posted | Number | participants | weekly from baseline until frame removal, up to 16 weeks |
|
|
|
| Primary | Change in Sepsis Rate | Patients will be assessed weekly for sepsis or until frame is removed. | Data not collected | Posted | weekly from baseline until frame removal, up to 16 weeks |
|
|
| 1 |
| 19 |
| 1 |
| 19 |
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