Prospective Evaluation of the Use of Intralesional Cryotherapy for Treatment of Keloid and Hypertrophic Scars

Amsterdam UMC, location VUmc

Status

Completed

Conditions

Keloid

Cicatrix, Hypertrophic

Treatments

Procedure: Intralesional cryotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT01994616

12/292

Details and patient eligibility

About

This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types.

Full description

Intralesional (IL) cryotherapy is a novel treatment for keloids and hypertrophic scars, in which the scar is frozen from inside. Published results are promising, however only Caucasian patient populations have been studied. This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types. All patients with keloid or hypertrophic scars meeting inclusion criteria were treated with a liquid nitrogen based device called Cryoshape Scar quality and possible recurrence are assessed pre- and postsurgery (3, 6 and 12 months) with objective devices determine scar color, scar elasticity, scar volume and patient's skin type. In addition, scars are evaluated using the Patient and Observer Scar Assessment Scale.

Enrollment

30 patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion
Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr)
A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks
Patients with all Fitzpatrick17 skin types
Patients older than 10 years of age

Exclusion criteria