To Be Printed on Local Trust Headed Paper

TO BE PRINTED ON LOCAL TRUST HEADED PAPER

THE PEGASUS TRIAL

Parent/Guardian Information Leaflet

A feasibility study and open pilot two-arm randomised controlled trial comparing Pressure Garment Therapy with no Pressure Garment Therapy for the prevention of abnormal scarring after burn injury (PEGASUS)

We would like to invite your child to take part in our research study. Before you decide whether you want them to take part we would like you to understand why the research is being done and what it would involve for your child. One of our team will go through the information leafletswith you and your child and will answer any questions you have.We‘d suggest this should take about 30 minutes Please ask us if anything is unclear or if you would like more information. Taking part is voluntary and it is up to you and your child to decide whether or not you would like them to take part.

Part (1) tells you the purpose of this study and what will happen to you if you take part.

Part (2) gives you more detailed information about the conduct of the study.

Part One

What is the purpose of the study?

The most common complication following burns reported in up to 70% of patients, is red and raised (hypertrophic) scarring. This study is designed to look at the use of pressure garment therapy in the prevention of hypertrophicscarring. Scarring occurs when the burn wounds are healed and can vary with age, race, genetic factors, burn type and depth. Some people’sscars remain flat and supple and others become lumpy and firm.

Currently a selection of scar treatments are used throughout the UK and the world, with each treatment claiming to be the most effective. Unfortunately due to the lack of research and evidence not one particular treatment can be described as being ‘the best’.

The following treatments claim to be the most effective:

• Pressure Garment Therapy
• Moisturisation (using moisturising creams and sun protection creams)
• Silicone (gels, creams, sheets and sprays)
• Massage

Pressure garments are bespoke Lycra® garments measured for and fitted by your scar management team and are recommended to be worn for 23 hours a day for up to 18 months.

Your child’s involvement will help us see whether or not,in the future we will be able to conduct a larger study to look at the whether using pressure garments with massage, moisturisation and silicone helps to flatten and soften burns scars or if using massage, moisturisation and silicone,without pressure garment therapy is just as effective.

Examples of Pressure garments:

Why has my child been invited to participate?

Your child has been asked to join our study because:

1. Theyhave sustained a burn injury greater than 1% of your total body surface area (TBSA)
2. Theyare eligible for scar management therapy intervention.

The trial will be carried out across six specialist burns units throughout the UK. Some centres specialise in treating adults or children, whereas others treat both adults and children.

Does my child have to take part?

It is up to you and your child to decide to whether or not to join the study. We will describe the study and go through some information leaflets with you and your child.You are free to withdraw your child at any time, without giving a reason. This would not affect the standard of care you receive.

What will happen to my child if they take part?

Participation in this study is voluntary. If you and your child decide that they would like to take part, a member of the study team, will explain the study to you and answer any questions you might have. They will ask you some questions about your health and any medication you may be taking. You will then be asked to sign a consent form and if appropriate, your child will be asked to sign an assent form. You should only do this if you are happy that you understand the project and want to take part.

If you consent for your child to participate they will be randomly allocated to either:

• Pressure garment therapy with massage, moisturisationand silicone or;
• Massage, moisturisationand silicone

This means that there is a 50:50 chance (the same as tossing a coin) that your child may or may not be allocated to wear pressure garments.

Your childwill be closely monitored at months one, three, six, nine and 12 over a 12 month period. The 12 month appointment will only be completed if this date is before September 2015 as analysis of the trial’s data will begin at this point.

At each visit (approx. 2 hours) your child’s assessments may include:

• Range of motion
• Measurement of their scar’selasticity
• Photographs of their scar
• Completion of questionnaires

If you agree for your child to take part in the trial, their hospital visits will be at the times when they would normally have hospital visits for their burn injury.

Expenses and Payments

Your child will not receive any expenses or payments for being involved in the study or for attending the outpatient appointments. There will be no additional hospital visits to make for the trial and all hospital visits will be at times when you would normally have appointments for your burn injury, as such, there will be no provision for travel expenses. Participants are not expected to pay for any treatments during the course of the trial.

What will I have to do?

The most important part of the study is attending all of the appointments and to comply with your therapy treatment plan i.e. massage, moisturisation, silicone and Pressure Garment Therapy (the latter, if applicable).

What alternative treatments are available?

Currently pressure garment therapy is just one of a range of treatments used in scar management. At the moment we do not know whether it is the pressure garment therapy or a combination of massage, moisturising cream and silicone that are useful in preventing hypertrophic scars.

What are the possible disadvantages and risks of taking part?

There are no associated risks with being involved in the study as all the procedures we are planning to perform are frequently performed in the hospital.In a small number of patients a rash may develop following the use of pressure garments and/ or silicone. If this happens please inform your child’s doctor, nurse or therapist and your treatment will be reviewed.

What are the possible benefits of taking part?

We are unable to guarantee any direct benefit to participants that take part in this trial. Nonetheless, your child will be contributing to an improved understanding of scar management therapy. The information gained from this trial will also contribute to further studies and may help improve the treatment of people with a burn injury in the future.

Part Two

What if relevant new information becomes available?

Sometimes we get new information about the treatment being studied. We will tell you and your doctor about it and give you and your child an opportunity to discuss it with a trial nurse or doctor. If this new information means that we should stop the study, or change how we are running it, we will do this and make sure that your childis offered the best treatment.

What will happen if I don’t want to carry on with the study?

You are free to withdraw your child from the study at any time and this will not affect their care. You can either withdraw your child completely or choose to keep in contact with us to let us know their progress. Information collected earlier in the study may still be used.

What if there is a problem?

If you have concerns about any aspect of this study, you should ask to speak to the research coordinator who will do her best to answer your questions (contact numbers below).

We do not anticipate that anything will go wrong. We will of course take great care that nothing goes wrong but if your child is harmed by taking part in this research you should understand that there are no special compensation arrangements. If your child is harmed due to someone’s negligence, then you may have grounds for a legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms are available to you: ask to speak to the complaints manager of the hospital.

If you have a concern about any aspect of this study you should ask to speak to the researcher who will do their best to answer your questions (insert Local PI contact details here). If you remain unhappy and wish to complain formally you can contact your local Patient Advice and Liaison Services (PALS) group or local equivalent group (insert name where applicable) (insert contact details here).

Quality of life assessment

It is important for us to understand the effect of your child’s scarring and treatment on their quality of life so that we can provide future patients with information on what they can expect to experience.

If your childis aged between five and 15 years old, they maybe asked to complete a questionnaire about their general well-being. If your child is aged between two and four years old, we may you ask you to complete a questionnaire on their behalf.

If your child is completing their own questionnaire, because only they truly know how they feel, we would like them to complete the questionnaire without input from family, loved ones or their clinical team. It is important to note that the data will be anonymised – no-one outside the research team will be able to identify your personal responses. The information you provide will be managed by the research team and summarised in reports at the end of the study.

This information will notbe used to inform your child’s clinical care directly; therefore, it is important that you let your clinical team (GP, nurse or hospital consultant) know if you have any concerns regarding their wellbeing. Support can also be found from: [Please add appropriate support info e.g. PALS]

Will my taking part in this study be kept confidential?

We will follow ethical and legal practice and all information about your childwill be handled in confidence. If you agree for your child to take part, their doctor will send basic information about your child and their condition to the PEGASUS Trial Office at the University of Birmingham Clinical Trials Unit (BCTU), on paper and electronically, where it will be securely stored under the provisions of the Data Protection Act 1998 and/or applicable laws and regulations. Information held by the NHS may be used to follow your progress. The study data may also be looked at by representatives of regulatory authorities and by other authorised people to check that the study is being carried out correctly. Your family GP, and other doctors involved in your child’s clinical care, will be kept informed. All those associated with the study will have a duty of confidentiality to you as a research participant.

In line with Good Clinical Practice Regulations, at the end of the study, the data will need to be securely archived for at least 5 years (but ideally not less than 25 years). Arrangements for confidential destruction will then be made.

Involvement of the General Practitioner/Family Doctor (GP)

You will be asked to give permission for us to tell your GP on your child’s behalf.

What will happen to the results of the research study?

The results will be published in medical journals or presented at medical conferences. All the information we present will continue to be anonymous. If you wish to be informed of the results of the study, please inform the research staff and we can ensure that this happens at the end of the study once all the information has been analysed.

Who is organising and funding the research?

The study is being coordinated by the University of Birmingham Clinical Trials Unit and is funded by the National Health Research’s Health Technology Assessment Programme (project number 12/145/04).

The research doctors will not receive a payment for including you in this study

Who has reviewed the study?

All research in the NHS is looked at by independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by East Midlands Ethics Committee.

Further information and contact details

If you require any further information please contact the research team on the details below. If you would prefer to speak to an independent person, regarding the trial please contact the Patients Advice and Liaison Service (PALS) on xxx xxxxxxx

Contact Details for research team:

Principal Investigator

Research Nurse

Scar Management Therapist

Parent/Guardian Information Leaflet V1.2,1st October 2014 Page 1 of 5