Cicatrix, Hypertrophic, Keloid
Conditions
Keywords
Keloid, hypertrophic scar
Brief summary
This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types.
Detailed 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.
Interventions
PROCEDUREIntralesional cryotherapy
Intralesional (IL) cryotherapy is a treatment for keloids and hypertrophic scars, in which the scar is frozen from inside with the use of a cryoneedle
Sponsors
Red Cross Hospital Beverwijk
Amsterdam UMC, location VUmc
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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
* pregnancy * diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | 0-12 months | Judgment of recurrence, defined as a growing, pruritic, nodular scar |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scar elasticity | 0-12months | Scar elasticity, measured in two parameters: extension and elasticity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Scar volume | 0-12months | Determined by creating a mold of the scar with dental putty |
| Redness (erythema) and pigmentation (melanin), | 0-12months | Redness (erythema) and pigmentation (melanin), which were measured using the DermaSpectrometer |
| Subjective scar evaluation | 0-12months | performed by two experienced medical doctors and the patient using the Patient and Observer Scar Assessment Scale (POSAS). Each item of the POSAS was scored using a 10-step score, in which 10 reflected 'worst scar imaginable' and 1 indicated 'normal skin' |
Countries
Netherlands
Outcome results
None listed