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Trial registered on ANZCTR


Trial ID
ACTRN12617000537358
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
13/04/2017
Date last updated
23/05/2018
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 291565 0
None
Universal Trial Number (UTN)
Trial acronym
DISTINCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incontinence Associated Dermatitis (IAD) 302658 0
Condition category
Condition code
Skin 302176 302176 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297628 0
Treatment: Devices
Intervention code [2] 297747 0
Prevention
Comparator / control treatment
Study participants who are randomised to be treated with the standard treatment will be considered the control group in this trial. Study protocol for control participants comprises of skin cleaning during daily bed bath with the use of a low pH no rinse liquid cleanser containing 2% CHG with warm tap water and soft cloths or a prepackaged wash cloth containing 2% CHG. Next a soft cloth/wipe impregnated with 3% dimethicone will be applied to the participant’s perianal area, buttocks and thighs after each daily bed-bath. Following each incontinence episode the exposed skin will be cleaned with tap water and soft clothes and gently dried and for participants with IAD, a soft cloth/wipe impregnated with 3% dimethicone will also be applied to the affected area.

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 later on in the day until the participant is discharged from the ICU or the IAD resolves.

The bedside nurse 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.
Control group
Active

Outcomes
Primary outcome [1] 301667 0
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).
Timepoint [1] 301667 0
The primary outcome will be assessed three times a week for the duration of the time the participant is within the ward.
Secondary outcome [1] 333498 0
Secondary Outcome 1: Duration of IAD. Skin assessments will be made with the IAD Severity Categorisation Tool.
Timepoint [1] 333498 0
The secondary outcome (1) will be assessed three times a week for the duration of the time the participant has IAD.
Secondary outcome [2] 333499 0
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.
Timepoint [2] 333499 0
The outcome will be assessed when 30 participants have successfully completed the trial.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of study group is concealed. Allocation will be done through pre-prepared sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomised into one of two subgroups (Intervention or Control). Study groups will be assigned using a computer generated random number generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations was performed for a Chi-Square test based on a change in the rate of IAD from 32% of control participants to 16% for the larger, follow-on parent study. Approximately 242 persons or 121 persons per group (inclusive of 10% attrition) with average ICU stay of 5 days and exposure to the causative factor, faecal incontinence, will be required to detect a 50% reduction in incidence with 90% power and significance of p<0.05.

Sample sizes in pilot study are recommended to be 10% of the larger parent follow on study and thus the sample size for the pilot study will be 30 participants, 12.45% of the predicted sample size for the larger, follow-on parent study.

Data will be analysed according to the principle of intention to treat. Descriptive data, including clinical and feasibility outcomes, will be analysed using frequencies, means as percentages as appropriate for continuous and categorical variables.

Kaplan-Meier survival analysis will be used to compare time to new IAD events between groups.

Prevention of IAD, will be measured by IAD scores in subjects whose IAD re-epithelialized and who continued on the investigational product. The proportion of participants who have no progression of IAD, while still experiencing incontinence, will be estimated.

Study data will be used to confirm the sample size calculation for a larger, follow study.



Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7773 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 15705 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 296053 0
Commercial sector/Industry
Name [1] 296053 0
3M Company
Address [1] 296053 0
3M Corporate Headquarters
3M Center
Building 223-6S-04
St. Paul, Minnesota
United States
55144-1000
Country [1] 296053 0
United States of America
Primary sponsor type
University
Name
Queensland University of Technology
Address
GPO Box 2434
Brisbane
QLD 4001
Country
Australia
Secondary sponsor category [1] 294944 0
None
Name [1] 294944 0
Address [1] 294944 0
Country [1] 294944 0
Other collaborator category [1] 279521 0
Hospital
Name [1] 279521 0
Royal Brisbane and Women's Hospital
Address [1] 279521 0
Intensive Care Services
Royal Brisbane and Women's Hospital
Level 3 Ned Hanlon Building
Butterfield Street
Herston, QLD, 4029
Country [1] 279521 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297310 0
Royal Brisbane and Womens Hospital Human Research Ethics Committee
Ethics committee address [1] 297310 0
HREC Office
Royal Brisbane & Women’s Hospital
Level 7
Block 7
Butterfield Street
Herston Qld 4029
Ethics committee country [1] 297310 0
Australia
Date submitted for ethics approval [1] 297310 0
27/01/2017
Approval date [1] 297310 0
10/03/2017
Ethics approval number [1] 297310 0
HREC/17/QRBW/21

Summary
Brief summary
Incontinence associated dermatitis (lAD) is a preventable skin condition in the bottom and genital area due to exposure to moisture and other irritants. lt is characterised by patchy inflammation of the skin and eventually leads to skin erosion. The patient may experience itching or burning sensations and/or pain and can suffer a decrease quality of life. lAD results in complications including increased risk of developing a pressure injury or a skin infection. As a result, lAD associated complications can be expensive for healthcare services. This study intends to evaluate the effectiveness of 3M Cavil on TM Advanced Skin Protectant to prevent, delay and/or reduce the severity of lAD, in critically ill patients in the intensive care setting. This pilot study aims to enroll 30 eligible study participants who have been appropriately consented and screened. The interventional product will be administered three times a week, with the control product (standard treatment) administered daily whilst the participant is in the intensive care setting. Study participants will be assessed at baseline, Day 1 then daily or three times a week with evaluations including demographics, product application, skin assessment and completion of questionnaires. In addition the incidence and severity of adverse events and performance of the interventional product will be documented.
Trial website
Nil
Trial related presentations / publications
Nil to Date
Public notes
Nil
Attachments [1] 1619 1619 0 0

Contacts
Principal investigator
Name 73666 0
Prof Fiona Coyer
Address 73666 0
Level 2
Centre for Clinical Nursing
Royal Brisbane and Women’s Hospital
Butterfield Street
Herston
QLD 4029
Country 73666 0
Australia
Phone 73666 0
+61 7 3646 2140
Fax 73666 0
Email 73666 0
f.coyer@qut.edu.au
Contact person for public queries
Name 73667 0
Prof Fiona Coyer
Address 73667 0
Level 2
Centre for Clinical Nursing
Royal Brisbane and Women’s Hospital
Butterfield Street
Herston
QLD 4029
Country 73667 0
Australia
Phone 73667 0
+61 7 3646 2140
Fax 73667 0
Email 73667 0
f.coyer@qut.edu.au
Contact person for scientific queries
Name 73668 0
Prof Fiona Coyer
Address 73668 0
Level 2
Centre for Clinical Nursing
Royal Brisbane and Women’s Hospital
Butterfield Street
Herston
QLD 4029
Country 73668 0
Australia
Phone 73668 0
+61 7 3646 2140
Fax 73668 0
Email 73668 0
f.coyer@qut.edu.au