Unna Boots for Ankle Fracture Swelling

NCT ID: NCT04086927

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2022-01-01

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.

Conditions

Ankle Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

Patients will not receive compression dressing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental Group

Patients will receive compression dressing

Group Type: EXPERIMENTAL

Unna Boot

Intervention Type: DEVICE

The unna boot is a zinc coated compression dressing

Interventions

Unna Boot

The unna boot is a zinc coated compression dressing

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• acute ankle fracture

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher E Gross, M.D.

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Surgeon

Other Identifiers

00092143

Identifier Type: -

Identifier Source: org_study_id