Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT04086927

Unna Boots for Ankle Fracture Swelling

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Medical University of South Carolina · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEUnna BootThe unna boot is a zinc coated compression dressing

Timeline

Start date
2021-01-31
Primary completion
2022-01-01
Completion
2022-01-01
First posted
2019-09-12
Last updated
2024-09-19

Source: ClinicalTrials.gov record NCT04086927. Inclusion in this directory is not an endorsement.