Unna Boots for Ankle Fracture Swelling

• ClinicalTrials.gov Identifier: NCT04086927
• Recruitment Status: Withdrawn
• First Posted: September 12, 2019
• Last Update Posted: January 12, 2021
• Sponsor: Medical University of South Carolina
• Information provided by (Responsible Party): Medical University of South Carolina

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ankle Fractures	Device: Unna Boot	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Unna Boot: A Technique to Decrease Preoperative Soft Tissue Swelling Following Ankle Fractures
• Estimated Study Start Date: January 31, 2021
• Estimated Primary Completion Date: January 1, 2022
• Estimated Study Completion Date: January 1, 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control Group; Patients will not receive compression dressing
Experimental: Experimental Group; Patients will receive compression dressing	Device: Unna Boot; The unna boot is a zinc coated compression dressing

Outcome Measures

Primary Outcome Measures :

1. Baseline swelling using Figure-8 Measurement [ Time Frame: 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.
2. Mean swelling using Figure-8 Measurement [ Time Frame: 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.
3. Mean pain scores on visual analogue scale at initial encounter [ Time Frame: Baseline (initial encounter) ]
   patients report a pain score of 1-10. 1 being the lowest and 10 being the highest
4. Mean pain scores on visual analogue scale at 6 week follow up visit [ Time Frame: 6 weeks follow up visit ]
   patients report a pain score of 1-10. 1 being the lowest and 10 being the highest

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• acute ankle fracture

Exclusion Criteria:

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

Contacts and Locations

Sponsors and Collaborators

Medical University of South Carolina

Investigators

• Principal Investigator: Christopher E Gross, M.D.; Orthopaedic Surgeon

More Information

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT04086927
• Other Study ID Numbers: 00092143
• First Posted: September 12, 2019
• Last Update Posted: January 12, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Fractures, Bone; Ankle Fractures; Wounds and Injuries