What is the mechanism of action of this treatment?

Common treatments for skin health, such as moisturizers and gentle cleansing techniques, primarily work by enhancing the skin's barrier function and maintaining hydration. Moisturizers containing ingredients like urea, glycerin, or glycyrrhetinic acid help to retain moisture and repair the skin barrier, which is crucial for preventing dryness and irritation. Gentle cleansing with weak wiping pressure, as opposed to ordinary pressure, preserves the skin's integrity and reduces the risk of damage, especially in vulnerable populations like older adults. These treatments are essential for skin health patients as they help to maintain the skin's protective functions, reduce the risk of infections, and improve overall comfort and quality of life.

What side effects are associated with this type of intervention?

Common treatments for skin health, such as moisturizers, barrier creams, and topical corticosteroids, generally have minimal side effects. Moisturizers and barrier creams are typically well-tolerated, with rare instances of skin irritation. Topical corticosteroids can cause skin thinning, stretch marks, and increased susceptibility to infections with prolonged use. Nonprescription acne treatments like salicylic acid and benzoyl peroxide may cause dryness, peeling, and rare but serious hypersensitivity reactions. Overall, these treatments are considered safe with proper use and monitoring.

What prior FDA approvals exist?

FDA-approved treatments for skin health include topical glycopyrronium tosylate for hyperhidrosis, which reduces excessive sweating and helps maintain skin integrity. For atopic dermatitis, treatments like topical tacrolimus and pimecrolimus are approved to reduce inflammation and improve skin barrier function. These treatments, while not directly related to ventilating suspension interfaces, share the goal of improving skin health by managing moisture and inflammation.

What other types of research exist?

Promising novel alternatives for improving skin health in patients include: 1) Weak wiping pressure during bed baths, which has been shown to be more effective in preventing skin disorders and providing satisfaction compared to ordinary pressure. 2) Hyperoxygenated fatty acid compounds, which have demonstrated effectiveness in preventing pressure ulcers. 3) Soft silicone multi-layered foam dressings, which have been effective in preventing pressure ulcers in high-risk patients. These alternatives can be considered for treatment in 2024.

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Prosthetic Suspension System

Ventilating vs Non-Ventilating Suspension Systems for Amputation

N/A

Recruiting

Research Sponsored by Össur Ehf

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Summary

This trial is testing a new type of artificial limb attachment that lets air flow through to keep the skin cool and dry. It focuses on people with above-knee amputations to see if this new system improves skin health compared to regular attachments.

Who is the study for?

This trial is for individuals over 18 years old who have had a below-knee amputation and weigh between 50-136 kg. They should be able to understand instructions, use a prosthetic liner, and have been confident prosthetic users for more than three months. The study excludes those not fitting these criteria or unable to follow the protocol.

What is being tested?

The investigation compares two types of lower limb prosthetic suspension systems: one with ventilation (AeroFit Seal-In Liner/Socket) and one without (Seal-In Silicone Liner). It aims to assess user-reported benefits on skin health from using these systems in daily life.

What are the potential side effects?

While specific side effects are not listed, potential issues may include discomfort, skin irritation or damage due to the fit and function of the liners and sockets being tested.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Subject perceived skin health (PEQ-RLH)

Secondary outcome measures

Incidents of prosthesis slippage, the need to remove liner to dry limb or liner and incidents of complete loss of suspension.

Subject perceived activity restriction and prosthesis use, TAPES-R

Subject perceived quality of life EQ-5D-5L

Trial Design

2Treatment groups

Experimental Treatment

Group I: Crossover BABExperimental Treatment2 Interventions

Group 1 starts using the ventilating suspension system (condition A), group 2 starts using non-ventilating suspension system (condition B) and then they cross-over to the other system, two times.

Group II: Crossover ABAExperimental Treatment2 Interventions

Group 1 starts using the ventilating suspension system (condition A), group 2 starts using non-ventilating suspension system (condition B) and then they cross-over to the other system, two times.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for skin health, such as moisturizers and gentle cleansing techniques, primarily work by enhancing the skin's barrier function and maintaining hydration. Moisturizers containing ingredients like urea, glycerin, or glycyrrhetinic acid help to retain moisture and repair the skin barrier, which is crucial for preventing dryness and irritation. Gentle cleansing with weak wiping pressure, as opposed to ordinary pressure, preserves the skin's integrity and reduces the risk of damage, especially in vulnerable populations like older adults. These treatments are essential for skin health patients as they help to maintain the skin's protective functions, reduce the risk of infections, and improve overall comfort and quality of life.

Atopic dermatitis and the indoor climate. The effect from preventive measures.Effectiveness of weak wiping pressure during bed baths in hospitalized older adults: A single-blind randomized crossover trial.Evidence-based treatment of atopic dermatitis with topical moisturizers.

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Who is running the clinical trial?

Össur EhfLead Sponsor

21 Previous Clinical Trials

3,832 Total Patients Enrolled

Media Library

AeroFit Seal-In Liner / Socket (Prosthetic Suspension System) Clinical Trial Eligibility Overview. Trial Name: NCT05925712 — N/A

Skin Health Research Study Groups: Crossover ABA, Crossover BAB

Skin Health Clinical Trial 2023: AeroFit Seal-In Liner / Socket Highlights & Side Effects. Trial Name: NCT05925712 — N/A

AeroFit Seal-In Liner / Socket (Prosthetic Suspension System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05925712 — N/A

Skin Health Patient Testimony for trial: Trial Name: NCT05925712 — N/A

~27 spots leftby Sep 2025

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