Diabetes Mellitus, Open Reduction External Fixation
Conditions
Keywords
Diabetes, Surgical Intervention, Honey
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.
Interventions
DEVICEMediHoney HCS dressing
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Medihoney HCS Dressing |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 19 |
| serious Total, serious adverse events | 1 / 19 |
Outcome results
Primary
Change in Sepsis Rate
Patients will be assessed weekly for sepsis or until frame is removed.
Time frame: weekly from baseline until frame removal, up to 16 weeks
Population: Data not collected
Primary
Number of Patients With Pin Site Infection
Patients will be assessed weekly for pin site infection up until frame removal.
Time frame: weekly from baseline until frame removal, up to 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medihoney HCS Dressing | Number of Patients With Pin Site Infection | 3 participants |
Primary
Total Number of Pin Sites
total number of pin sites for all patients enrolled
Time frame: Day of surgical intervention approximately 3hrs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medihoney HCS Dressing | Total Number of Pin Sites | 244 total number of pin sites |