This case study is part of the live twitter learning session on Saturday 10th April 2021. For more information, please follow @receivingconsnt and see the pinned tweet. – Emma
In case study 1 we will meet Jakub and Sophia – 2 potential participants for the FeeLyne* study, a study looking at which wound dressing is superior in enucleation surgery.
*Please note this is an entirely fictitious study and BioLyne does not exist
Key details:
- The study is testing the safety and efficacy of an exciting new dressing which is impregnated with a newly developed substance, “BioLyne” thought to accelerate the healing process and cut down on infection rates.
- There is only one surgeon who is currently involved with the study and both Jakob and Sophia are on her list to have their operations in 2 weeks time.
- You will be meeting Jakob and Sophia at their pre-operative visit in the outpatients clinic. They have both already been sent the study information by post and are both aware of the operation they are going to be having.
- The inclusion criteria is any patient undergoing enucleation surgery for any reason. There are no exclusion criteria. Patients must have capacity to consent to participation in the study.
- If the patient decides to go ahead with the study, the dressing allocated to be used will be chosen at random. The patient will not know which is used but the surgeon and team will.
- The patient must agree to avoid cats for the first 21 days following surgery if they take part in this study. This is because there is a concern that cat hair may interact with the trial dressing and cause redness and swelling at the dressing site. There are no other known potential interactions.
- Both dressings are the same size. The dressings will be changed and assessed by a specialist ophthalmic research nurse.
- The patient will be asked to complete a questionnaire at 6hrs, 12hrs, 24hrs and 48hrs following surgery. The research nurse will come to the patient’s bedside to ask the questions.
- Once the patient goes home, they will be given a diary and asked to fill it in every day for a week. There will be a follow-up phone call at 3, 6 and 12 months. The research team will also monitor the patient’s health by checking medical records.
Jakub – is a 84 year old who has had been suffering with eye pain since a fall 2 years ago. He was on warfarin for atrial fibrillation and when he fell, he hit his eye and had a severe intra-ocular bleed which resulted in him losing his sight completely. His vision in his right eye is described as “good” and he is able to read with glasses. He wishes to go ahead with the enucleation in the hope it will relieve the pain he experiences.
Sophia – is a 67 year old who has had an intra-ocular malignancy in her right eye. Her current vision in her right eye is very poor but she does have perception of light. Her vision in her left eye is described as “poor” but she can see very large print. She is keen to go ahead with the enucleation in the hope that it will stop the advancement of the malignancy.
Receiving Consent 