Patient Information Sheet
Stratpharma topical medical devices – continuous post marketing surveillance
The following document may help you to understand the information already discussed by your Doctor regarding your participation in a clinical research study. It may give you the opportunity to decide whether or not to participate – after knowing the possible risks and benefits of such a study. The information obtained from this study may possibly be helpful to others.
The variety of dressings and topical agents available commercially for skin problems or diseases is extensive. There is currently no uniform consensus amongst professionals for the best protocol for many indications.
Conventionally, the approach to skin indications has been the application of moisturizers, lotions, topical antibiotic or steroid ointment. This practice is based more on perception and habit, and not on sound scientific evidence, especially regarding reduction in adverse reactions. In addition, this scenario may contribute to increase the risk of allergic contact dermatitis.
The aim of this clinical research study is to confirm the efficacy, safety and tolerability of Stratpharma topical medical devices as used in their commercial indications. Stratpharma medical devices are topical silicone gels that have been developed from advanced forms of silicone polymers in a gel format that dry to form a very thin and flexible silicone gel dressing making it an effective and convenient therapy for the treatment of many skin conditions.
Study Procedure:
If you have at least one of the following conditions you will be invited to participate in this study:
• Abnormal scar(s)
• Acute wound (from different sources, like surgery or trauma)
• Chronic wound (from different sources, venous syndrome, pressure ulcer etc)
• Stretch marks (either existing or in the risk of forming e.g. due to pregnancy)
• Compromised skin surface (from elective surgery)
• Skin rashes (including but limited due to reactions to drugs)
• Radiation dermatitis (a side effect of radiation therapy
If you agree to participate in this study your affected area will be treated with Stratpharma’s range of topical medical devices. A secondary dressing may be applied in addition to Stratpharma’s products at the discretion of the treating physician or nurse.
The study product to which you are allocated will depend on the indication you are being treated for.
Strataderm or StrataTriz: abnormal scars
• Stratamed or StrataGRT: acute or chronic wounds
• Stratamark: treatment or prevention of stretch marks
• Stratacel: compromised skin surface
• StrataCTX: skin rashes
• StrataXRT: radiation dermatitis
You will be assessed for the purpose of the study during your normal follow up visits with your physician as part of standard clinical practice. You will be asked to answer a questionnaire about the product features and your personal experience at the last visit.
Photographs
Your doctor/nurse may take photographs of treated area at the beginning of treatment and then again at each subsequent visit as applicable as a visual record of the progress. By signing this form you are agreeing that the photograph can be published, reproduced and displayed for medical or commercial purposes with your identity obscured. Under no circumstance will your identity be shown.
Expected duration of your participation
The participation in this study will be determined by the normal follow up visits with your physician as part of standard clinical practice. You are not expected to continue participation beyond standard clinical practice.
Potential Risks
Silicone is considered a safe product to use on the skin. All the ingredients of Stratpharma products have been tested and approved for use. Since no adverse device effects are known so far there is no known risk from use of Stratpharma products.
Should you experience any irritation or allergy please consult your doctor/nurse.
You should not take any other medication or use other creams to help your treated area during the study period unless instructed by your doctor. This includes over the counter medications. If you do so, you must inform the doctor/nurse at your next visit. In such a case, you might be withdrawn from the study.
If discontinuation of the studied products occurs due to allergy (or another reason), substitution of alternative products is at the treating clinician’s discretion.
Confidentiality
Your medical records will be treated with confidentiality and will be revealed only to other doctors / scientists of this study and if required, to the regulatory authorities – FDA and to the Independent Ethics Board – Allendale IRB. The results of this study may be published in a scientific journal but you will not be identified by your name.
Your Participation & Your Rights
Your participation in this study is voluntary and you may withdraw from the study at any time without having to provide reasons. If at any time you feel worse or suffer from any other illness, then, please let it be known to your attending Doctor/nurse. If the treatment appears to be unsuitable for you, it will be stopped. You will be informed of any significant new findings about Stratamed which may occur during the study & which may have a bearing on your participation in the study. If you do agree to take part in this study, your health records will need to be made available to the manufacturer of Stratamed, health authorities and relevant regulatory authorities. If you do not wish to participate initially or further at any later stage, the level of care you receive will in no way be affected. If the treatment appears suitable for you and you are satisfied by this treatment, your physician may continue the same treatment for you. This study has been submitted to an Independent Ethics Committee. Should any problem or question arise with regard to this study, with regard to your rights as a participant in clinical research or with regard to any research related injury, you should contact the following persons:
Dr Staab
Allendale Independent Review Board
Tel: 860 434 5872
• Stratpharma products will be provided for the use in the trial free of charge
• You will not receive any payment for participating in the study
Name/Position Contact Ph: After Hours Emergency contact Ph:
Amanda Irwin, MD
Principal Investigator
+1 619 930 5788 +1 619 930 5788
Email contact Address Internal code
medical@stratpharma.com
eserrano@stratpharma.com
Aeschenvorstadt 57
4051 Basel, Switzerland SPAPMSALL001
Product contents
Stratpharma products
Polysiloxanes,
Siloxane resin
Polydimethylsiloxanes,
siloxanes,
alkylmethyl silicones
Informed Consent for use of Product User Feedback
I exercising my free power of choice, hereby give my consent for feedback and/or photographs my Doctor/Nurse and I provide regarding my experience using Stratpharma products to be used by the product Manufacturer, Stratpharma, for the following purposes:
Withdrawal
Participation in this study is entirely voluntary and you may withdraw at any time without affecting your care at this hospital either now or in the future.
If you decide to discontinue the study treatment, the investigator may request for your permission to attend follow-up visits to allow collection of information regarding your health status. Alternatively, the investigator may request your permission to access my medical records for collection of follow-up information for research and analysis
Post Marketing Surveillance
I agree that Stratpharma can use the feedback that my Doctor/Nurse and I provide in order to monitor how effective this product is from both a Healthcare Professional`s and a patient’s point of view, and also to collate information regarding the user`s experience. I agree that the feedback that my Doctor/Nurse and I provide can be used by Stratpharma without compensation or remuneration for the purpose of medical training, product marketing, and promotion at congresses targeting healthcare professionals.
I grant to Stratpharma AG the right to reproduce, and display my feedback without compensation or remuneration, for the purpose of medical training, product marketing and promotion at congresses targeting healthcare professionals. Stratpharma will not use my personal information contained in this informed consent document for any other purpose than as a record of my consent to use product feedback provided as stated.
I am aware that if I wish to withdraw my consent for my feedback to be used in this way then I am free to do so and will contact Stratpharma in writing at the following address to notify that I wish to withdraw my consent:
Stratpharma AG Aeschenvorstadt 57 CH-4051 Basel Switzerland
Where consent is withdrawn, Stratpharma will destroy the “Informed Consent for use of Product Feedback” form containing my personal information and the applicable feedback form. Stratpharma will remove any feedback provided from our database.
I confirm that I understand and agree with all above stated terms of consent.