Unna Boots for Ankle Fracture Swelling

Medical University of South Carolina (MUSC)

Status: Withdrawn

Conditions: Ankle Fractures

Treatments: Device: Unna Boot

Study type: Interventional

Funder types: Other

Identifiers

NCT04086927

00092143

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• acute ankle fracture

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control Group

No Intervention group

Description:

Patients will not receive compression dressing

Experimental Group

Experimental group

Description:

Patients will receive compression dressing

Treatment:

Device: Unna Boot