Objective Assessment of Radiation Induced Skin Fibrosis
Research type
Research Study
Full title
Objective Assessment of Radiation Induced Skin Fibrosis in the Head and Neck Pre and Post Lipotransfer Treatment (student study)
IRAS ID
182205
Contact name
Peter Butler
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
UCL Data Protection Registration number , Z6364106/2016/04/71
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Radiation induced fibrosis (RIF) is a common late complication of radiotherapy, resulting in progressive functional and cosmetic impairment, which can be particularly devastating in the head and neck. Limitations in speech, eating and self-care occur secondary to tissue scarring and contracture. The associated facial disfigurement can induce psychological distress in the form of anxiety or depression. Current reconstructive options are limited. Autologous fat grafting (using patient's own fat) has been utilized as a filler to contour deformities for several years. Several papers have been published describing regression of RIF following autologous fat treatment. However, a major limitation of existing clinical research is the lack of experimental data that quantifies fibrosis. Studies draw conclusions based on subjective, imprecise outcome measures, making statistical evaluation difficult and potentially introducing bias.
In this study, we will use a variety of non-invasive techniques to objectively assess the quality of fibrotic skin in response to autologous fat treatment. Professor Butler and Mr Kalavrezos will identify participants in preoperative clinic at the Royal Free Hospital and University College London Hospital, prior to their fat treatment that are suitable for the study. Dr Griffin will gain written consent on the day of their operation to enter the study.
Firstly, we will perform a physical assessment to evaluate the patient’s baseline pain, mobility and sensation. Secondly, ultrasound will be used to assess blood flow and tissue viability in irradiated skin. The stiffness and elasticity of the skin will also be assessed. Questionnaires will be provided to assess the healing from the patient’s perspective. All investigations will be repeated following fat treatment.
The information gained from this study will improve our knowledge of the efficacy of fat treatment for RIF, allowing us to improve our reconstructive surgical techniques and provide better outcomes for patients requiring these types of reconstructive surgeries.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1603
Date of REC Opinion
31 Aug 2016
REC opinion
Further Information Favourable Opinion