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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39619

Enrollment

176

Registered

2012-06-29

Start date

2012-11-07

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Excessive scar tissue fibroproliferative disorder

Interventions

1) Primary keloids: intralesional cryotherapy or extralesional excision with adjuvant triamcenolonacetonide 40mg/ml injections starting 2 weeks post operative. 2) Recurrent keloids: intralesional cr

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary endpoint is POSAS score.	—

Secondary

Measure	Time frame
Secondary endpoints are volume reduction, Skindex-29, SF-36, ED-5Q, QST, histology, appearance of adverse reactions and indication for further treatment.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)