Who will take informed consent? {26a}
illness, disability
EVENT
ResNs at each site trained in Good Clinical Practice (GCP) screen and recruit participants, obtain their consent, and randomly allocate them to a study group via an independent web-based randomisation service (in accordance with the hospital procedures informed by state governance and international standards). Written informed consent is sought from each patient, family member, or legal guardian (proxy) prior to randomisation.If consenting participants are allocated to the intervention group, they will be asked to assess their level of satisfaction with comfort of the dressing. They may also be invited to participate in an individual interview conducted by the research assistant to describe their experience of participating in the trial, as part of the process evaluation.If the participant or their person responsible (i.e. proxy) is unable to read, an impartial witness must be present during the entire consent process. After the patient or their proxy has orally consented to the patient’s participation and has signed the consent form, the witness must also sign and date the consent to attest the information is understood by the patient or their proxy and consent was given freely. Furthermore, where the impairment, disability, or illness is temporary or episodic, an attempt will be made to seek consent at a time when the condition does not interfere with the person’s capacity to give consent.Participants, their family member, or legal guardian are advised that they can withdraw from the study at any time and that withdrawal will not jeopardise any treatment or relationship with the hospital. A Revocation of Consent form is provided to all participants on enrolment as a means of withdrawal and clearly states that in the event of participant withdrawal, data already collected will be included in the aggregated analysis but that no further data will be collected.