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Electrosclerotherapy for capillary malformations: study protocol for a randomised within-patient controlled pilot trial.

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.

SUBMITTER: Horbach SER

PROVIDER: S-EPMC5695370 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Electrosclerotherapy for capillary malformations: study protocol for a randomised within-patient controlled pilot trial.

Horbach Sophie E R SER Wolkerstorfer Albert A de Bruin Daniel Martijn DM Jansen Sanne M SM van der Horst Chantal M A M CMAM

BMJ open 20171114 11

<h4>Introduction</h4>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 inc ...[more]

PMID: 29138199

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Project description:BACKGROUND:Striae gravidarum (stretch marks) are considered the most common connective tissue/skin change in pregnancy. Though not a health issue they can affect women in different ways, for example, cause stress or be an aesthetic or cosmetic concern. Many women use one or more of the commercially available products to try and prevent their development during pregnancy despite the fact that that there is a lack of high-quality evidence to support their use. There is a dearth of studies on the prevention of striae gravidarum and large, robust trials are lacking. Until such time as more products are investigated, much of the knowledge remains anecdotal. This pilot study will evaluate the feasibility of conducting a study to evaluate the effectiveness of a commercially available moisturising oil compared to no treatment for the prevention and reduction in severity of striae gravidarum. METHODS:The definitive study will be a randomised controlled trial to evaluate the effectiveness of a moisturising oil (commercially available moisturising oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum. This protocol is for a pilot randomised trial to evaluate the feasibility of conducting such a study. The pilot study will be a two-arm, unblinded, pragmatic parallel randomised trial with a 1:1 randomisation ratio between control and intervention groups. Women in the intervention group will be asked to apply a moisturising oil to their abdomen during pregnancy, while women in the control group will not use any treatment. It is proposed to recruit 20 primigravida, who are 12-16 weeks pregnant from an Irish Maternity Hospital, in each arm to assess the feasibility of running such a trial. DISCUSSION:This pilot trial will evaluate the feasibility of conducting the main study to evaluate the effectiveness of a moisturising oil (commercially available moisturising oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum. It will potentially initiate the generation of high-quality evidence to guide women in their choice of anti-stretch mark product. TRIAL REGISTRATION:ISRCTN Registry, ISRCTN76992326 . Registered on 14 July 2017.

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Project description:IntroductionAlthough diabetes distress is found to be associated with decreased glycaemic control among adults with type 1 diabetes, the psychological and emotional impact of living with the condition is often not recognised and often under-reported in diabetes care. Therefore, regular assessment of diabetes distress is recommended. Assessment of diabetes distress using patient-reported outcome measures (PROMs) in clinical practice has the potential to enhance care for people with diabetes by identifying problems and improving patient-clinician communication. In this study protocol, we describe a pilot randomised controlled trial (RCT) aiming to test the feasibility of all components of an empowerment-based intervention using PROMs as dialogue support in clinical diabetes consultations, and to address the uncertainties associated with running a fully powered evaluation study.Methods and analysisWe will undertake a two-arm pilot RCT of an intervention using the Problem Areas In Diabetes (PAID) scale in clinical diabetes consultations in order to conclude whether a fully powered trial is appropriate and/or feasible. The study will also include qualitative indepth interviews with participants and healthcare providers. Our objectives are to (1) evaluate the recruitment procedures and attrition rates; (2) evaluate the performance of the randomisation procedure; (3) evaluate the participants' mean scores on the outcome measures before and after the intervention; (4) evaluate if the intervention consultations are acceptable and feasible; and (5) explore patients' and healthcare providers' experiences with the use of PAID as dialogue support and empowerment-based communication skills in clinical diabetes consultations. The quantitative data analysis includes descriptive statistics (frequencies, percentages, means, SD and CI). For the qualitative data, we will perform thematic analysis.Ethics and disseminationEthical approval has been obtained from the Western Norway Regional Committee for Medical and Health Research Ethics (2017/1506/REC west). We will present the findings from the study phases at national and international conferences and submit manuscripts to peer-reviewed journals and popular science journals.Trial registration numberNCT03471104; Pre-results.

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Dataset Information

Electrosclerotherapy for capillary malformations: study protocol for a randomised within-patient controlled pilot trial.

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Electrosclerotherapy for capillary malformations: study protocol for a randomised within-patient controlled pilot trial.

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