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Dermatology
Protocol
Electrosclerotherapy for capillary malformations: study protocol for a randomised within-patient controlled pilot trial
  1. Sophie E R Horbach1,
  2. Albert Wolkerstorfer2,
  3. Daniel Martijn de Bruin3,
  4. Chantal M A M van der Horst1
  1. 1Department of Plastic, Reconstructive and Hand Surgery, Academic Medical Center (AMC), University of Amsterdam, Amsterdam, Noord-Holland, Netherlands
  2. 2Department of Dermatology, Academic Medical Center (AMC), University of Amsterdam, Amsterdam, Noord-Holland, Netherlands
  3. 3Department of Biomedical Engineering and Physics, Academic Medical Center, University of Amsterdam, Amsterdam, Noord-Holland, Netherlands
  1. Correspondence to Dr Sophie E R Horbach; s.e.horbach{at}amc.uva.nl

Abstract

Introduction The current state-of-the-art treatment modality for hypertrophic capillary malformations (CMs), laser therapy, has a considerable rate of non-responders and recurrence. Intralesional bleomycin injections (or ‘sclerotherapy’) are commonly used to treat venous and lymphatic malformations with an excellent effect, but these intravascular injections are not possible in CMs due to the small diameter of the vessels. Electroporation—an electric field applied to the tissue—could increase the permeability of endothelial cells, which could theoretically facilitate targeted localised bleomycin delivery. We therefore hypothesise that bleomycin injections in combination with electroporation—‘electrosclerotherapy’ (EST), also known as ‘electrochemotherapy’—could potentially be a novel alternative treatment option for CMs.

Methods and analysis In this randomised within-patient controlled pilot trial, 20 patients with hypertrophic CMs will be enrolled. Three regions of interest (ROIs) within the CM will be randomly allocated for treatment with (A) EST, (B) bleomycin sclerotherapy without electroporation and (C) no treatment. Patients and outcome assessors are blinded for the treatment allocation. Treatment outcome for each ROI will be measured approximately 7 weeks after the treatment procedure, using patient-reported and physician-reported global assessment scores, colorimetry, laser speckle imaging and reporting of adverse events.

Ethics and dissemination The study protocol is approved by the ethics review committee of the Academic Medical Center, Amsterdam. Results will be published in peer-reviewed medical journals and will be presented at international conferences and scientific meetings. Study results will be fed back to the patient population through website and social media notifications.

Trial registration number NCT02883023;Pre-results. NTR6169.

  • capillary malformations
  • vascular malformations
  • electrosclerotherapy
  • bleomycin
  • electroporation
  • electrochemotherapy

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-016401

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    Footnotes

    • Contributors SERH, AW and CMAMH were involved in the inception of the study. SERH, AW, DMB and CMAMH conceptualised and designed the study. SERH, AW and CMAMH will collect data. SERH, AW, DMB and CMAMH will perform data analyses or interpretation of data. SERH drafted the initial manuscript of this study protocol. AW, DMB and CMAMH revised the manuscript for intellectual content and approved the final manuscript as submitted.

    • Funding This work was supported by a personal academic research scholarship, received by the corresponding author SERH. IGEA S.p.A. provided the materials needed for this study free of charge.

    • Competing interests None declared.

    • Ethics approval The Institutional Review Board of the Academic Medical Center in Amsterdam approved the study protocol (V1.1, 25 October 2016).

    • Provenance and peer review Not commissioned; externally peer reviewed.

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