Evaluate the Efficacy of Two Advanced Skin Treatment Regimens in Treating Incontinence-associated Dermatitis: Cluster Randomization Study
Phase: NA
Conditions: Incontinence-associated Dermatitis
Sponsor: Tan Tock Seng Hospital

Study Protocol and Data Analysis Plan – Dated 05 Aug 2020 
Title: Evaluate the Efficacy of Two Advanced Skin Treatment Regimens in Treating Incontinence-associated 
Dermatitis: Cluster Randomization Study 
 
Study protocol 
 
Study design 
An open-label, cluster randomized, three-group, prospective study will be adopted. Cluster randomization will 
be used to allocate the selected wards to the experimental or control group for ease of operation (Hemming, 
Eldridge, Forbes, Weijer, amp; Taljaard, 2017), avoiding confusion on the treatment regimens and cross-
contamination of subjects (Sedgwick, 2012). The randomized code for the nursing units will be generated using 
www.randomizer.org as Treatment 1 or Treatment 2 or Control. Blinding is not possible as the treatment 
products cannot be “masked”. A purposive sampling on inpatients with IAD will be recruited into the study 
upon consent. The inclusion and exclusion criteria are as listed in K1 amp; K2. The participants will 
automatically follow the randomization code selected (implied either control or treatment arm) by the nursing 
unit he is being admitted.  
Study materials 
Control 
The control regimen for IAD is the current standard of care implemented by the organizations participating in 
the study. The control regime are combination of treatment - varied practices currently for the treatment of 
IAD – including the use of potassium permanganate, barrier cream or zinc oxide with skin wipes or soap and 
water for cleaning 
Treatment products 
The recommended treatment for IAD should include a structured skin care regimen containing a skin cleanser 
and a skin protectant. The chemical components recommended as protectants should contain either zinc-
based, petrolatum-based, dimenthicone-based, or an acrylic polymer. The four preselected products for 
review are: (1) Conveen easi cleanse and Coloplast Conveen critic barrier (2) 3M No rinse cleanser and 3M 
Cavilon No string Barrier Film (3) 3M No rinse cleaner and 3M Cavilon Advanced Skin Protectant(4) Smith and 
Nephew Moisturizing cleanser and Secura EP cream 30% 
Study process 
 
Screening/Recruitment 
1. When a potential candidate is identified, the research team members will be activated.  
2. Eligible participants from the cluster randomized nursing units will be screened. If they meet the 
inclusion/exclusion criteria, the PI / co-I will be approached the participants face-to-face.  
3. The study information will be explained to them at their individual bedside cubicles or a quiet corner of the 
nursing unit for semi-ambulant participants. Time will be given for consideration to the study. All questions 
asked 
will be answered. Upon verbal agreement, the consent will be taken using the appropriate ICFs attached. 
4. The nurse-in-charge/doctor-in-charge of the patient will be notified of the participant's agreement to the 
study. 
Study day process 

Study Protocol and Data Analysis Plan – Dated 05 Aug 2020 
5. Arrangement will be made with the nurse-in-charge to synchronize the daily skin assessments with the 
study assessment to avoid unnecessary exposure. 
6. An initial baseline assessment (Day 0) will be conduct on the participant’s buttocks, posterior aspect of thigh 
and perineal region. The subject will be placed on a lateral comfortable position. 
7. Observations made will include the amount and extent of denudement, exudate level, redness, signs of 
infection and the skin condition. 
8. A baseline photo will be taken prior treatment. 
9. Concealed treatment codes placed in a sealed opaque envelope will be used for randomizing the cluster. 
Each nursing units will be asked to draw the sealed envelope. With the sealed envelopes contained numbers 1 
to 3 where 1 = Standard of care (control), 2 = Treatment regimen 1, 3 = Treatment regime 2. Each draw will 
determine the allotted treatment for the study site to adopt. 
10. The treatment products will be issued to the nurse for application. 
11. The treatment regimens will be applied as per manufacturer’s recommendation.  
12. Patients will be followed up three times a week for a maximum of 21 days, or until the IAD has healed or 
discharged from the study site.  
13. Each review (including baseline assessment), photos will be taken to document the extent of the IAD over 
the buttocks and/or thighs and/ or perineal region. 
14. All assessments will be made using IADS-D and GLOBIAD tool. Permissions to use the assessment tool has 
been given.  
15. On Day 3, 5 and 7, an assessment will be made to the skin appearance if the IAD has not resolved. 
16. Patients on treatment regimens will be identified using visual cue - different flower icons. Patients on 
control regimens will be treated as per hospital policy on data management 
17. All collected data will be entered into the CRF. 
18. Upon completion of the data collection, the data will be transcribed into EXCEL and validated 
independently by two different assigned persons. 
19. The validated data in EXCEL will be imported into SPSS and R for data analysis on a later date.  
 
Data collection 
 
Baseline parameters and other outcome measures that will be collected include the pain scores, classification 
of IAD and healing rates, episodes of incontinence, deterioration to PI or development of other adverse events 
(Kon et al., 2017) will be collected based on the case record form. Subsequently, 4 more assessments will be 
made on the participants on the progress of the IAD following treatment(s)/control regimens.  
 
 
 
Data Analysis plan 
 

Study Protocol and Data Analysis Plan – Dated 05 Aug 2020 
All data will be entered into a Microsoft Office Excel 2013 and independently verified for accuracy of the 
transcription. The data will then be imported into Statistical Package for the Social Sciences (SPSS) IBM Version 
24 and R for analysis and coding. Descriptive analysis including means and standard deviations or medians and 
interquartile ranges for the numerical variables and frequencies for categorical variables will be used to 
describe the study sample characteristics. ANOVA will be used to analyse for group differences. The measure 
of effect (risk difference or mean difference) and a confidence interval or measure of variation will be 
examined. The intra-cluster correlation coefficient (ICC) will be examined with an ICC of 0.10 used as the 
acceptable determine for cluster independence during observations (Thomson 2012). Multivariate regression 
will be used to evaluate the effect of treatment regimens, adjusting for risk factors. A significance level of 0.05 
will be used.  
 
 
We will measure skin characteristics by an independent wound nurse clinician to determine if the photographs 
reflected any change in skin, size of redness, skin infection or other changes during the follow-up of days 1, 3, 
5 and 7 after application of the product. Photographs will be examined to detect any signs of improvement or 
deterioration in skin condition – redness, maceration of skin and skin erosion (Van de Bussche et al., 2018). A 
copy of the photograph assessment form is attached. The outcome measures include the pain scores, 
assessment scores for IAD and healing rates, episodes of incontinence, deterioration to PI or development of 
other adverse events (Kon et al., 2017).