An interventional study of Intralesional cryotherapy in Keloid, Cicatrix and Hypertrophic, sponsored by Amsterdam UMC, location VUmc. Completed at 1 site in Netherlands. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2014-02-14.
Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Treatment
This prospective evaluation studies the effectiveness of Intralesional (IL) cryotherapy with a argon gas based device in treating keloids and hypertrophic scars in population consisting of all Fitzpatrick skin type patients
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 population consisting of all Fitzpatrick skin type patients.
Multiple devices are available, mostly based on a simple open system. Closed, argon gas based, systems are highly controlled and provide accurate freezing. However, this technique has never been used for IL cryotherapy for the treatment of keloid or hypertrophic scars. All patients with keloid or hypertrophic scars meeting inclusion criteria were treated with a argon based device called Seednet. 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.
123 studies on the registry are indexed under Keloid; 23 are open to participants now.
This study's enrollment of 33 is close to the median of 30 across 97 interventional studies indexed under Keloid.
Browse Keloid studies →Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.
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Exclusion Criteria:
All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy
Procedure: Intralesional 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
Also known as: Seednet
Recurrence
Judgment of recurrence, defined as a growing, pruritic, nodular scar
Time frame: 0-12 months
Scar elasticity
Scar elasticity, measured in two parameters: extension and elasticity
Time frame: 0-12months
Scar volume
Determined by creating a mold of the scar with dental putty
Time frame: 0-12months
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Amsterdam UMC, location VUmc