Surgical and aesthetic outcome, quality of life, and cost-effectiveness of keloid treatment

Completed

• Conditions: 10014982; Excessive scar tissue; fibroproliferative disorder

• Registration Number: NL-OMON39619
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 176

Inclusion Criteria

Keloid patients, 18-75 yr old, full mental competence, sufficient knowledge of Dutch or English language, keloid suitable for primairy closure after excision, minimum keloid size of 1x1cm.

Exclusion Criteria

Hypertrofic scars. Keloids less than 1 year existent, burn scars, pregnancy, previous radiotherapy which prohibits additional rediotherapy (only for the group of recurrent keloids), hypersensitivity for lidocaine, adrenaline, triamcinolone. Chronic use (>1 month) of systemic corticosteroids, or immunosuppressive medication (e.g. TNF alfa inhibitors). Use of systemic chemotherapy. Severe morbidity with a life expectancy of less than one year.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is POSAS score.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Secondary endpoints are volume reduction, Skindex-29, SF-36, ED-5Q, QST,<br /><br>histology, appearance of adverse reactions and indication for further<br /><br>treatment.</p><br>