Intervention
skin irritation, itchiness, allergic reaction
ALLERGIC REACTION, FAECAL INCONTINENCE
Where there is evidence of skin irritation and/or participant-reported discomfort and/or itchiness due to the dressing, the dressing will be removed, the skin reaction reported using standard hospital incident reporting protocols, and the patient exited from the clinical study. Where the patient has developed persistent urinary and/or faecal incontinence, the sacral dressing will be removed, and the patient exited from the clinical study. In our pilot trial, only six participants (5% of the total sample) reported dressing discomfort, due to dressing migration or mild itchiness without any other clinical symptoms of allergic reaction [Note that in either group, diagnosis of a sacral HAPI resulting in the patient exiting the study will be made on a case-by-case basis in consultation with the clinician caring for the patient and/or the team leader. This decision will not influence the assessment of the outcome assessor (i.e. they will not be aware of the decision made by the clinician/team leader). Where there is indecision among the clinical staff caring for the patient regarding the diagnosis of a Stage 1 PI, the assessment by the blinded assessor will be used to determine if the patient should exit the clinical study.