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Recruiting NCT07547488

Influence of Dressings on Skin pH Alterations in Simulated Skin Folds in Healthy Subjects

No phase Interventional Skin Folds

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dressings.
Who it may be relevant to
Registry conditions: Skin Folds. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study investigates the effect of different dressings on skin pH when applied to a simulated skin fold environment.

Detailed description

This study evaluates the impact of various dressings on skin pH when applied to a simulated skin fold environment. To replicate the occlusive conditions commonly found in skin folds, a non-breathable film will be placed over the dressings, maintaining occlusion for approximately 24 hours.

Skin pH measurements will be taken during two separate visits: once before dressing application and again after approximately 24 hours of wear time. Both measurements will be conducted on the same location on the forearms of healthy participants. The goal is to investigate how different dressings influence skin pH under occlusive conditions.

Interventions

  • Device Dressings
    Sorbact® Ribbon, Sorbact® Compress and InterDry®

Primary outcome measures

  • Difference in skin pH [Time frame: 24 hours of wear time]
Secondary outcome measures (3)
  • Difference in skin pH [Time frame: 24 hour of wear time]
  • Difference in skin pH [Time frame: 24 hours of wear time]
  • Change in skin hydration under occlusion from baseline [Time frame: 24 hours of wear time]

Eligibility criteria

Inclusion criteria

  • Written informed consent to participate in this study
  • Healthy men and women between 18-80 years
  • Patient is mentally and physically able to participate in this study
  • Intact skin on the forearms without any signs of irritation
  • Agreed on not to shower or use cosmetic products on the arms the same day as visit 1 and during the study period
  • Agreed not to engage in intense physical activity throughout the study period

Exclusion criteria

  • Skin disorder of any kind.
  • Known allergy to adhesives or/and any other component(silver) in the investigation devices.
  • Pregnant or lactating women.
  • Presence of tattoos on the forearms.
  • Ongoing medication with antibiotic.
  • Suffer from excessive sweating, hyperhidrosis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Sweden · 1 center
  • Essity Study site — Mölndal

Identifiers

NCT: NCT07547488 · pHase

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗