Unna Boots for Ankle Fracture Swelling

Study Overview
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Brief Summary
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This study will evaluate the difference in soft tissue swelling prior to surgery and wound complications after surgery between unna boot application versus standard splint application. An unna boot is an extra zinc covered wrap around your leg followed by standard splint application (cotton dressing, plaster, then soft dressing). Prior to surgery the participant's swelling will be measured and compared to the standard splint application group. After surgery, the participant will be monitored for wound complications, pain, and range of motion.

Detailed Description
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The purpose of this study is to compare preoperative swelling and frequency of wound complications in ankle fractures through standard splint and an unna boot compressive dressing with a splint. Quantitative and qualitative measurements will be analyzed to compare edema and wound complications. Secondary goals are to evaluate the quantitative differences in ankle range of motion and visual analogue scale (VAS) pain scores. The hypothesis of this proposed study is that there will be less soft tissue swelling and wound complications with the use of an unna boot when compared to the standard splint. The investigators also hypothesize that there will be improved ankle range of motion and visual analogue scale (VAS) pain scores with the use of an unna boot when compared to a standard splint. Participants will be randomized to either the standard splint or an unna boot and quantitative and qualitative measures will be collected. This data could change the practice for preoperative management of soft tissue swelling following ankle fractures.

Official Title
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Unna Boot: A Technique to Decrease Preoperative Soft Tissue Swelling Following Ankle Fractures

Conditions
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Ankle Fractures

Intervention / Treatment
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* Device: Unna Boot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute ankle fracture Exclusion Criteria: low energy ankle fracture open ankle fracture unwillingness to participate allergy to zinc revision surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients will not receive compression dressing | |
| Experimental: Experimental Group<br>Patients will receive compression dressing | Device: Unna Boot<br>* The unna boot is a zinc coated compression dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline swelling using Figure-8 Measurement | Physician uses tape measure to measure angles to determine swelling severity of ankle. This measurement is taken by making a figure eight pattern on the foot and ankle. The measurement is taken three times and then averaged to give the final total. | Baseline (Initial encounter) | 
| Mean swelling using Figure-8 Measurement | Physician uses tape measure to measure angles to determine swelling severity of ankle. This measurement is taken by making a figure eight pattern on the foot and ankle. The measurement is taken three times and then averaged to give the final total. | 6 weeks follow up visit | 
| Mean pain scores on visual analogue scale at initial encounter | patients report a pain score of 1-10. 1 being the lowest and 10 being the highest | Baseline (initial encounter) | 
| Mean pain scores on visual analogue scale at 6 week follow up visit | patients report a pain score of 1-10. 1 being the lowest and 10 being the highest | 6 weeks follow up visit |