Determining the possible association of skin irritation threshold and hypertrophic scar formatio

Completed

• Conditions: littekenhypertrofie van de huid; Hypertrophic scar; raised scar; 10014982

• Registration Number: NL-OMON43681
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Reduction mammoplasty, at least 3 months post-operative
18 years of age or older
Legally competent
Patient group: scar hypertrophy in at least one of the scars
Control group: all scars have remained normal (flat) during the entire post-operative period

Exclusion Criteria

Fitzpatrick photo skin type V
Skin disease, skin lesions
Immunological disorders
Pregnancy/lactation or systemic immunosuppressive treatment during the first two years post-operatively or during the patch test

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the IT as determined by visual irritation<br /><br>grading scale after SLS patch test.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are IL1a/IL1Ra ratios in the SC, TEWL, erythema<br /><br>as measured with DermaSpectrometer®, response of PBMC*s to stimulation with<br /><br>LPS, leukocyte numbers and cytokines in serum.</p><br>