Efficacy of Incontinence Associated Dermatitis Interventions for Critically Ill Patients in Intensive Care: the Distinct Pilot Randomised Control Trial.

The Distinct Pilot Trial is a Phase III pilot study to determine the efficacy of the skin preparation, Cavilon Advanced Skin Protectant, against standard treatment for IAD in critically ill patients in intensive care setting. The intervention product, Cavilon Advanced Skin Protectant, is a liquid product which turns into a thin, waterproof, flexible, transparent barrier when exposed to skin and air using a product applicator. The active ingredients are hexamethyldisiloxane, acrylic tetrapolymer and 2-octyl cyanoacrylate. The intervention product is designed to both prevent and treat IAD by maintaining skin integrity and promote an environment for healing. The product is contained in a vial with applicator. Once the vial is broken, the product can be distributed over the skin with the applicator sponge. Each vial contains enough product to cover 650 square cm of skin and the product dries completely within 60 seconds. Further information about the intervention product can be found at (http://www.3m.com/3M/en_US/company-us/all-3m-products/~/All-3M-Products/Health-Care/Medical/Skin-Wound-Care/Barriers-Creams-Lotions/?N=5002385+8707795+8707798+8711017+8711098+8711102+3294857497&rt=r3) and (http://www.3m.com/3M/en_US/company-us/all-3m-products/~/3M-Cavilon-Advanced-Skin-Protectant-5050?N=5002385+8711102+3291589704&rt=rud) Study participants who are randomised to be treated with the intervention product will be monitored for initially for 12 hours to determine any sensitivity to an intervention product test patch (3 x 3 cm on the upper thigh). The product will then be applied 3 times a week to the participant’s perianal area, buttocks and thighs by the Research Nurse following the bed bath while the patient remains within the ICU. The intervention product will be continued to be applied to participants who have IAD at discharge from the ICU while they remain in the hospital until their IAD resolves. Study protocol for intervention participants also comprises of skin cleaning by the bedside nurse during daily bed bath with the use of a low pH no rinse liquid cleanser containing 2% chlorhexidine gluconate (CHG) with warm tap water and soft cloths or a prepackaged wash cloth containing 2% CHG and following each incontinence episode where the exposed skin will be cleaned with tap water, soft clothes and gently dried. Skin assessments of the presence and severity of IAD and pain assessments be performed 3 times a week by the research nurse during patient turns until the participant is discharged from the ICU or the IAD resolves. Bedside and research nurses will receive training in product application before the commencement of the study. The research nurse will receive training for skin and pain assessments before the commencement of the study. Training will be given by the investigators, Professor Coyer and Jill Campbell, who are both recognized clinical and research experts in IAD. All training will be provided face to face. Further general study information sessions will be provided at the hospital site for all clinicians. Bedside nurses will complete a bed bath check list to show adherence to protocol for both study groups with the Research nurse evaluating the protocol fidelity.