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Electrosclerotherapy for capillary malformations: study protocol for a randomised within-patient controlled pilot
Sophie E R Horbach1, Albert Wolkerstorfer2, Daniel Martijn de Bruin3
1Department of Plastic, Reconstructive and Hand Surgery, Academic Medical Center (AMC), University of Amsterdam, Amsterdam, Noord-Holland, Netherlands.
BMJ Open
|November 16, 2017
Summary
Electrosclerotherapy (EST), combining bleomycin with electroporation, is being investigated as a novel treatment for hypertrophic capillary malformations (CMs). This pilot trial compares EST to bleomycin alone and no treatment to assess efficacy and safety.
Area of Science:
- Vascular Anomalies
- Dermatology
- Regenerative Medicine
Background:
- Hypertrophic capillary malformations (CMs) currently lack effective treatments, with laser therapy showing limited success.
- Intralesional bleomycin is effective for venous and lymphatic malformations but not feasible for CMs due to vessel size.
- Electroporation may enhance drug delivery by increasing endothelial cell permeability.
Purpose of the Study:
- To investigate electrosclerotherapy (EST) as a novel treatment for hypertrophic CMs.
- To compare the efficacy of EST, bleomycin sclerotherapy, and no treatment in a randomized controlled trial.
Main Methods:
- A randomized, within-patient controlled pilot trial involving 20 patients with hypertrophic CMs.
- Three treatment arms: EST, bleomycin sclerotherapy alone, and no treatment.
- Outcomes assessed using patient/physician global assessment, colorimetry, and laser speckle imaging.
Main Results:
- This is a pre-results abstract; no results are available yet.
- The study is registered (NCT02883023, NTR6169) and awaiting data analysis.
- Adverse events will be systematically reported.
Conclusions:
- EST presents a potential new therapeutic option for hypertrophic CMs.
- Further research is needed to confirm the efficacy and safety of EST.
- Study findings will be disseminated through publications and conferences.
