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

Essity Hygiene and Health AB40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Skin Folds

Interventions

DressingsDEVICE

Sorbact® Ribbon, Sorbact® Compress and InterDry®

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Written informed consent to participate in this study 2. Healthy men and women between 18-80 years 3. Patient is mentally and physically able to participate in this study 4. Intact skin on the forearms without any signs of irritation 5. Agreed on not to shower or use cosmetic products on the arms the same day as visit 1 and during the study period 6. Agreed not to engage in intense physical activity throughout the study period Exclusion Criteria: 1. Skin disorder of any kind. 2. Known allergy to adhesives or/and any other component(silver) in the investigation devices. 3. Pregnant or lactating women. 4. Presence of tattoos on the forearms. 5. Ongoing medication with antibiotic. 6. Suffer from excessive sweating, hyperhidrosis.

Locations (1)

Essity Study site

Mölndal, Sweden

RECRUITING

Outcomes

Primary Outcomes

Difference in skin pH

Difference in skin pH between the simulated skin fold and the area under Sorbact® Compress, measured after approximately 24 hours of wear time

Time frame: 24 hours of wear time

Secondary Outcomes

Difference in skin pH

Difference in skin pH between the simulated skin fold and the area under Sorbact® Compress,

Time frame: 24 hour of wear time

Difference in skin pH

Difference in skin pH between the simulated skin fold and the area under InterDry®,

Time frame: 24 hours of wear time

Change in skin hydration under occlusion from baseline

Change in skin hydration from baseline to after wear time, measured in the simulated skinfold under occlusion using a moisture meter

Time frame: 24 hours of wear time

Central Contacts

Fana Hunegnaw

CONTACT

+46761361512 fana.hunegnaw@essity.com

Data from ClinicalTrials.gov

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