Waterproof Padding vs Non-waterproof Padding for Short Leg Walking Casts

Overseen By David Tager, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

Disqualifiers: Foot wounds, Cognitive dysfunction

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3-7 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to determine whether the use of waterproof padding in short leg walking casts will lead to an increase in cast-related complications, as compared to the standard non-waterproof casting in children.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of waterproof padding compared to non-waterproof padding for short leg walking casts?

Research shows that waterproof casts provide similar support and immobilization as non-waterproof ones, while allowing for better physical function and higher patient satisfaction. They also enable activities like swimming and bathing without additional risks, making them a practical choice for maintaining hygiene and comfort. ^{1 2 3 4 5}

Is waterproof padding for short leg walking casts safe for humans?

Research shows that waterproof padding for casts is generally safe, with minor skin issues reported in a small percentage of cases. Studies found no significant risks, and patients experienced similar levels of comfort and satisfaction compared to non-waterproof padding. ^{1 2 3 4 6}

How does waterproof padding differ from non-waterproof padding in short leg walking casts?

Waterproof padding for short leg walking casts allows patients to maintain their usual hygiene routines and engage in water activities without damaging the cast, unlike non-waterproof padding which requires keeping the cast dry. This makes waterproof padding more convenient and user-friendly, especially for maintaining cleanliness and comfort. ^{1 2 5 7 8}

Research Team

David Tager, MD

Principal Investigator

West Virginia University

Eligibility Criteria

This trial is for children who need a short leg walking cast due to conditions like ankle or foot fractures, sprains, toe-walking, tendinitis, or apophysitis. It's not suitable for those with pre-existing wounds on the foot or ankle or cognitive dysfunction that would interfere with the study.

Inclusion Criteria

I have a sprained foot.

I am in a short leg walking cast for a foot or ankle condition.

I have a sprained ankle.

Exclusion Criteria

I have had wounds on my foot or ankle before getting a cast.

Patients with cognitive dysfunction

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a waterproof or non-waterproof short leg walking cast

3-7 weeks

1 visit (in-person) for cast application

Follow-up

Participants return for cast removal and complete questionnaires on cast and skin condition, satisfaction, and mobility

1 visit upon cast removal

1 visit (in-person) for cast removal and assessments

Treatment Details

Interventions

• Non-waterproof padding
• Waterproof padding

Trial Overview The study is testing if waterproof padding in short leg walking casts reduces complications compared to standard non-waterproof casting. The goal is to see which type of padding better serves children during their recovery from lower leg injuries.

Participant Groups

Group I: Waterproof padding Active Control 1 Intervention

Waterproof, short leg walking cast for 3-7 weeks

Group II: Non-waterproof padding Active Control 1 Intervention

Non-waterproof, short leg walking cast for 3-7 weeks

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

References

1. United States pubmed.ncbi.nlm.nih.gov

Waterproof casts for immobilization of children's fractures and sprains. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Waterproof cast liners in paediatric forearm fractures: a randomized trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

It is not just comfort: waterproof casting increases physical functioning in children with minimally angulated distal radius fractures. [2018]

4. England pubmed.ncbi.nlm.nih.gov

A More Comfortable Cast? [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A Prospective Randomized Crossover Study on the Comparison of Cotton Versus Waterproof Cast Liners. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Waterproof versus cotton cast liners: a randomized, prospective comparison. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Inexpensive alternatives for extremity cast and bandage protection. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Slipper cast management of emergency foot problems. [2019]