Unna Boots for Ankle Fracture Swelling

Not Applicable

Withdrawn

• Conditions: Ankle Fractures
• Interventions: Device: Unna Boot

• Registration Number: NCT04086927
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-12
• Study Start: 2021-01-31
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• acute ankle fracture

Exclusion Criteria

• low energy ankle fracture
• open ankle fracture
• unwillingness to participate
• allergy to zinc
• revision surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Unna Boot	Patients will receive compression dressing

Primary Outcome Measures

Name	Time	Method
Baseline swelling using Figure-8 Measurement	Baseline (Initial encounter)	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.
Mean swelling using Figure-8 Measurement	6 weeks follow up visit	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.
Mean pain scores on visual analogue scale at initial encounter	Baseline (initial encounter)	patients report a pain score of 1-10. 1 being the lowest and 10 being the highest
Mean pain scores on visual analogue scale at 6 week follow up visit	6 weeks follow up visit	patients report a pain score of 1-10. 1 being the lowest and 10 being the highest