vascular malformations capillary malformations port-wine stains wijnvlekken capillaire malformaties
Conditions
Interventions
All participants undergo one intervention session in which 3 homogeneous 1.5x1.5 cm parts of the capillary malformation are randomly allocated to [1] electrosclerotherapy, [2] bleomycin injection with
Sponsors
Academic Medical Center (AMC)
Eligibility
Inclusion criteria
Inclusion criteria: - Patients with ¡Ý1 completely or partially hypertrophic capillary malformation not exclusively located in the skin of the face, the skin overlying joints or in mucosal tissue - Age ¡Ý 18 years - Fitzpatrick skin type 1-3 without evident sun tan
Exclusion criteria
Exclusion criteria: - Patients with capillary malformations exclusively located in the face, in the skin overlying joints or in mucosa - Pregnant or breastfeeding women - Women with childbearing potential not using contraception - Patients with chronic renal dysfunction of GFR <50 ml/minute - Patients with chronic pulmonary dysfuction, active pulmonary infections or previous bleomycin lung toxicity - Patients with ataxia teleangiectasia - Patients with previous allergic reactions to bleomycin - Patients who already received the maximum dose of bleomycin (400 units mg or 400000 IU/m2) - Patients with implanted electrical devices such as pacemakers or ICD's - Patients with clinically manifested arrhythmia - Patients with epilepsy - Patients who are not able to return to the hospital for follow-up visits - Patients who are likely not able to understand the terms and risks of the study (e.g. cognitive impairment) - Legally incompetent adults - Patients of which informed consent was not obtained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - (Change in) global assessment of color, thickness, nodularity, pliability, surface area and overall improvement by both the patient and a blinded observer using a global assessment score and the POSAS instrument. - In terms of safety, we will investigate the number and type(s) of adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| - (Change in) color measured using colorimetry - (Change in) perfusion of the capillary malformations, measured using optical imaging techniques. | — |
Contacts
Public ContactC.M.A.M. van der Horst
Department of Plastic, Reconstructive and Hand Surgery, Academic Medical Center, University of Amsterdam
Outcome results
None listed