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Semi-permanent tattoos in breast radiotherapy (STaBRad) study: a randomised-controlled clinical trial comparing the ‘Precision Plus Micropigmentation System’ to permanent skin tattoos in radical breast radiotherapy patients

Published online by Cambridge University Press:  10 November 2017

A. O’Neill*
Affiliation:
Radiotherapy Department, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust, Belfast, UK Centre for Cancer Research & Cell Biology, Queen’s University Belfast, Belfast, UK
S. McAleer
Affiliation:
Clinical Oncology, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
H. McCarty
Affiliation:
Clinical Oncology, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
J. Clarke
Affiliation:
Clinical Oncology, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
A. Drake
Affiliation:
Clinical Oncology, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
J. Hurwitz
Affiliation:
Medical Oncology, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
A. Clayton
Affiliation:
Medical Oncology, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
E. Shaw
Affiliation:
Oncology Nursing, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust, Belfast, UK
H. Vennard
Affiliation:
Radiotherapy Department, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust, Belfast, UK
S. Gray
Affiliation:
Radiotherapy Department, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust, Belfast, UK
J. Robinson
Affiliation:
Radiotherapy Department, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust, Belfast, UK
B. Simpson
Affiliation:
Radiotherapy Department, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust, Belfast, UK
M. Stevenson
Affiliation:
Centre for Public Health, Queen’s University Belfast, Belfast, UK
G. G. Hanna
Affiliation:
Centre for Cancer Research & Cell Biology, Queen’s University Belfast, Belfast, UK Clinical Oncology, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
J. M. O’Sullivan
Affiliation:
Centre for Cancer Research & Cell Biology, Queen’s University Belfast, Belfast, UK Clinical Oncology, Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
*
Correspondence to: Angela O’Neill, Radiotherapy Department, Cancer Centre, Belfast City Hospital, Lisburn Road, Belfast BT9 7AB, UK. Tel: 02895048236. E-mail: [email protected]

Abstract

Introduction and purpose

Accurate and reproducible patient positioning is a critical step in radiotherapy for breast cancer. This has seen the use of permanent skin markings becoming standard practice in many centres. Permanent skin markings may have a negative impact on long-term cosmetic outcome, which may in turn, have psychological implications in terms of body image. The aim of this study was to investigate the feasibility of using a semi-permanent tattooing device for the administration of skin marks for breast radiotherapy set-up.

Materials and methods

This was designed as a phase II double-blinded randomised-controlled study comparing our standard permanent tattoos with the Precision Plus Micropigmentation (PPMS) device method. Patients referred for radical breast radiotherapy were eligible for the study. Each study participant had three marks applied using a randomised combination of the standard permanent and PPMS methods and was blinded to the type of each mark. Follow up was at routine appointments until 24 months post radiotherapy. Participants and a blind assessor were invited to score the visibility of each tattoo at each follow-up using a Visual Analogue Scale. Tattoo scores at each time point and change in tattoo scores at 24 months were analysed by a general linear model using the patient as a fixed effect and the type of tattoo (standard or research) as covariate. A simple questionnaire was used to assess radiographer feedback on using the PPMS.

Results

In total, 60 patients were recruited to the study, of which 55 were available for follow-up at 24 months. Semi-permanent tattoos were more visible at 24 months than the permanent tattoos. Semi-permanent tattoos demonstrated a greater degree of fade than the permanent tattoos at 24 months (final time point) post completion of radiotherapy. This was not statistically significant, although it was more apparent for the patient scores (p=0·071) than the blind assessor scores (p=0·27). No semi-permanent tattoos required re-marking before the end of radiotherapy and no adverse skin reactions were observed.

Conclusion

The PPMS presents a safe and feasible alternative to our permanent tattooing method. An extended period of follow-up is required to fully assess the extent of semi-permanent tattoo fade.

Type
Original Articles
Copyright
© Cambridge University Press 2017 

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