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| Name | Class |
|---|---|
| Red Cross Hospital Beverwijk | OTHER |
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This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| keloid or hypertrophic scars | All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralesional cryotherapy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | Judgment of recurrence, defined as a growing, pruritic, nodular scar | 0-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Scar elasticity | Scar elasticity, measured in two parameters: extension and elasticity | 0-12months |
| Measure | Description | Time Frame |
|---|---|---|
| Scar volume | Determined by creating a mold of the scar with dental putty | 0-12months |
| Redness (erythema) and pigmentation (melanin), | Redness (erythema) and pigmentation (melanin), which were measured using the DermaSpectrometer |
Inclusion Criteria:
Exclusion Criteria:
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A mixed patient population with all Fitzpatrick skin types
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| Name | Affiliation | Role |
|---|---|---|
| Michiel CE van Leeuwen, MD | VUmc | Principal Investigator |
| Frank B Niessen, PhD, MD | Vumc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VUmc | Amsterdam | North Holland | 1081HV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12711943 | Background | Har-Shai Y, Amar M, Sabo E. Intralesional cryotherapy for enhancing the involution of hypertrophic scars and keloids. Plast Reconstr Surg. 2003 May;111(6):1841-52. doi: 10.1097/01.PRS.0000056868.42679.05. | |
| 25626801 | Derived | van Leeuwen MCE, van der Wal MBA, Bulstra AJ, Galindo-Garre F, Molier J, van Zuijlen PPM, van Leeuwen PAM, Niessen FB. Intralesional cryotherapy for treatment of keloid scars: a prospective study. Plast Reconstr Surg. 2015 Feb;135(2):580-589. doi: 10.1097/PRS.0000000000000911. |
| Label | URL |
|---|---|
| homepage VU medical center, hospital Amsterdam, the Netherlands | View source |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
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| 0-12months |
| Subjective scar evaluation | 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' | 0-12months |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |