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

• Register: ANZCTR
• Last refreshed on: 16 September 2019
• Main ID: ACTRN12617000537358
• Date of registration: 13/04/2017
• Prospective Registration: Yes
• Primary sponsor: Queensland University of Technology
• Public title: Efficacy of Incontinence Associated Dermatitis Interventions for Critically Ill Patients in Intensive Care: the Distinct Pilot Randomised Control Trial.
• Scientific title: Efficacy of Incontinence Associated Dermatitis Interventions for Critically Ill Patients in Intensive Care: the Distinct Pilot Randomised Control Trial.
• Date of first enrolment: 02/08/2017
• Target sample size: 30
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617000537358.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 3

Countries of recruitment

Australia

Contacts

• Name: Prof Fiona Coyer

• Name: Prof Fiona Coyer

Key inclusion & exclusion criteria

Inclusion criteria: 1) >17 years of age
2) Incontinent of urine and/or stool.
3) Predicted ICU length of stay (LOS) of at least 5 days

Exclusion criteria: 1) Burns.
2) Colorectal surgery resulting in a colostomy
3) Current pressure area ulcer/sore where the skin is affected by incontinence.
4) Current community-acquired IAD.
5) Continent of urine and faeces.
6) Have a dermatological disease (e.g. psoriasis, eczema) that is likely to interfere with the evaluation of the patient.
7) Presence of a fungal infection on the study area
8) Are currently enrolled in 3 non-intervention drug or device studies in the ICU research site
9) Currently participating in an investigational drug or device study.
10) The participant has a medical condition that in the opinion of the investigator would exclude him/her from participating in the study.
11) Hypersensitivity to CavilonTM Advanced Skin Protectant or its excipients.


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Skin - Dermatological conditions

Incontinence Associated Dermatitis (IAD);
Incontinence Associated Dermatitis (IAD)

Intervention(s)

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

Primary Outcome(s)

The primary outcome is the development of IAD. The primary outcome will be assessed by direct clinical examination of the skin surrounding participant’s perianal area, buttocks and thighs. Diagnosis of IAD will be made using the IAD Severity Categorisation Tool (Beeckman D et al. (2015). Proceedings of the Global IAD expert Panel. Incontinence-associated dermatitis: Moving prevention forward. Wounds International. Retrieved from http://www.woundsinternational.com/media/other-resources/_/1154/files/iad_web.pdf).[The primary outcome will be assessed three times a week for the duration of the time the participant is within the ward. ]

Secondary Outcome(s)

The secondary outcome (2) is to assess the feasibility of of conducting a larger, adequately powered trial testing the product using the pilot study design. Outcomes or benchmarks for a successful study will be:-
a. Eligibility: >= 80% of potentially eligible patients screened will be eligible
b. Recruitment: >= 80% of eligible participants will agree to enrol
c. Protocol fidelity: >= 95% of participants in the intervention group will receive prescribed intervention
d. Retention: < 10% of patients will be lost to follow up.
[The outcome will be assessed when 30 participants have successfully completed the trial.]

Secondary Outcome 1: Duration of IAD. Skin assessments will be made with the IAD Severity Categorisation Tool.[The secondary outcome (1) will be assessed three times a week for the duration of the time the participant has IAD. ]

Secondary ID(s)

None

Source(s) of Monetary Support

3M Company

Ethics review

Status: Approved
Approval date:
Contact:

Royal Brisbane and Womens Hospital Human Research Ethics Committee