Unna Boots for Ankle Fracture Swelling

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04086927
• Other study ID #: 00092143
• Status: Withdrawn
• Phase: N/A
• Start date: January 31, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2021
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• acute ankle fracture

Exclusion Criteria:

• low energy ankle fracture

• open ankle fracture

• unwillingness to participate

• allergy to zinc

• revision surgery

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

Device:
• Unna Boot
The unna boot is a zinc coated compression dressing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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)
Primary	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