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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two types of padding for short leg walking casts to determine if waterproof padding increases cast-related problems in children. The researchers will compare waterproof padding to the standard non-waterproof kind, focusing on differences in complications. Children needing a short leg cast for ankle or foot fractures, sprains, toe-walking, tendonitis (inflammation of a tendon), or apophysitis (painful swelling where tendons attach to bone) may be suitable participants. As an unphased trial, this study provides an opportunity to enhance understanding of better options for children's cast comfort and safety.

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 prior data suggests that these padding methods are safe for use in short leg walking casts?

Research has shown that waterproof padding for casts is generally safe. Some studies found that only a small number of people experienced minor skin issues, such as irritation, with no major differences in problems compared to traditional non-waterproof padding.

For non-waterproof padding, studies also found no significant risks. People reported similar comfort and satisfaction levels as with waterproof padding.

Overall, both waterproof and non-waterproof paddings are well-tolerated, with no major safety concerns reported in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of waterproof padding in short leg walking casts compared to the traditional non-waterproof option. Waterproof padding allows patients to bathe and even swim without needing to cover the cast, which can significantly improve comfort and convenience during the recovery period. Additionally, this approach could reduce skin irritation and odor, common issues with non-waterproof casts. By comparing these two padding types, the trial aims to determine whether the waterproof option can enhance the overall patient experience without compromising the effectiveness of the cast.

What evidence suggests that this trial's treatments could be effective for short leg walking casts?

This trial compares waterproof padding with non-waterproof padding for short leg walking casts. Research has shown that waterproof padding is generally safe, with only minor skin issues in a few cases. Studies found no major differences in problems between waterproof and non-waterproof casts. Participants using waterproof padding can wet their casts without damage, offering more convenience for activities like bathing. In contrast, those with non-waterproof padding must keep their casts dry. Both types of padding support healing in short leg walking casts. ^{1 2 3 4 6}

Who Is on the Research Team?

David Tager, MD

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04961957

Waterproof Casting Versus Standard Casting for Short Leg ... 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 ...

2. withpower.com withpower.com/trial/phase-sprains-and-strains-9-2021-aba5a

Waterproof Padding vs Non-waterproof Padding for Short ... 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 ...

3. jscimedcentral.com jscimedcentral.com/public/assets/articles/burns-8-1052.pdf

Are Waterproof Casts More Cost Effective than Non-Water ... The purpose of this study was to compare clinical outcomes and costs of treatment of extremity injuries with non-waterproof casts (NWPC) ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38329338/

Traditional Versus Water-resistant Short Leg Casting Results: Sixty patients were included in this study, thirty in each group. The water-resistant casts took longer to apply than the traditional ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S276827652500080X

Lower Extremity Cast Application In another recent study by Hennrikus et al., they confirmed that a short leg walking cast is an effective method for immobilizing childhood accidental spiral ...

6. researchgate.net researchgate.net/publication/351934808_Cast-Related_Complications

Cast-Related Complications When rolling cast padding on the extremity, there should be 50% overlap at a minimum so that there are at least two layers of the cast padding ...