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Trial registered on ANZCTR


Registration number
ACTRN12625000896471p
Ethics application status
Submitted, not yet approved
Date submitted
24/07/2025
Date registered
18/08/2025
Date last updated
18/08/2025
Date data sharing statement initially provided
18/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Application of Stomal Sponges to Eliminate Leakage (TASSEL)
Scientific title
A Single-Centre, Quasi-Experimental Controlled Before-and-After Study Evaluating the Application of Stomal Sponges to Eliminate Leakage (TASSEL) in Neonatal High-Output Stoma Management
Secondary ID [1] 314990 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TASSEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Jejunostomy 338310 0
Ileostomy 338311 0
Peristomal skin complications 338312 0
High-output stoma 338313 0
Condition category
Condition code
Oral and Gastrointestinal 334603 334603 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Reproductive Health and Childbirth 334604 334604 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves the use of the Stomal Sponge, a TGA-approved, Class Ia, non-sterile, single-use absorbent insert made from compressed polyvinyl alcohol (PVA). It is specifically designed for use inside stoma bags to absorb liquid effluent, thereby reducing recontact with the baseplate opening. The device is intended to reduce the frequency of unplanned appliance changes and minimise peristomal skin complications in neonates with high-output jejuno- or ileostomies.

During each routine stoma appliance change, a neonatal nurse inserts a single Stomal Sponge into the base of the stoma bag. The sponge expands upon contact with stool, holding the effluent in the bottom of the bag and away from the baseplate and adhesive interface. No additional materials are provided to families aside from the Parent/Guardian Information and Consent Form (PICF). All procedures are integrated into routine bedside care and documented using existing neonatal clinical tools.

The intervention is delivered face-to-face, individually, at the Mater Mothers’ Neonatal Critical Care Unit (NCCU) in South Brisbane, Australia. It is administered by experienced neonatal nurses trained in both neonatal stoma management and the specific requirements of the TASSEL study protocol. The principal investigator is a Registered Nurse with demonstrated expertise in neonatal surgical care and stomal therapy.

Each enrolled infant receives the intervention over a period of up to 14 days or until discharge, whichever occurs first. Frequency of use is based on clinical need and volume of stoma output, with most infants requiring 1 to 2 sponge insertions per day. Adherence to the intervention protocol is monitored through daily clinical records and cross-checked against standardised stoma observations and skin assessments. No tailoring or modification of the intervention is planned. Intervention fidelity will be reviewed by the research team using documentation consistency and compliance with the protocol.
Intervention code [1] 331579 0
Treatment: Devices
Comparator / control treatment
Historical controls will be drawn from a predefined period between 1 January 2022 and 31 December 2023. This dataset is retrieved independently as a fully anonymised extract and is never linked to live study identifiers or bedside prompts, maintaining a clear operational and administrative boundary between participants and non-participants throughout the project.

The comparator group consists of neonates who met the same eligibility criteria as the intervention cohort but did not receive the Stomal Sponge. These infants underwent standard post-surgical stoma management using appropriately fitted stoma appliances without any in-bag output-absorbing agents. Stoma care was delivered by neonatal nursing staff at Mater Mothers’ NCCU in accordance with routine clinical practice at the time.

The historical data period predates the introduction of the Stomal Sponge and excludes any infants documented as having received gelling agents or other in-bag materials. All comparator outcomes are extracted from routine clinical documentation.
Control group
Historical

Outcomes
Primary outcome [1] 342284 0
Unplanned stoma bag changes due to leakage
Timepoint [1] 342284 0
Daily from Day 1 to Day 14 post-enrolment or until discharge (primary timepoint: Day 14)
Secondary outcome [1] 450237 0
Mean stoma appliance wear time (hours per bag)
Timepoint [1] 450237 0
Over the course of the intervention period, from Day 1 (the day of Stomal Sponge application) to Day 14 post-enrolment or until hospital discharge, whichever occurs first.
Secondary outcome [2] 450238 0
Clinically significant peristomal skin breakdown
Timepoint [2] 450238 0
Assessed daily from Day 1 to Day 14 post-enrolment or until discharge
Secondary outcome [3] 450239 0
Parent-reported experience of stoma care, assessed as a composite outcome encompassing confidence, involvement, and perceived infant discomfort.
Timepoint [3] 450239 0
Collected at enrolment (Day 1) and again at Day 14 or discharge (whichever occurs first)

Eligibility
Key inclusion criteria
1. Neonates who have undergone jejunostomy or ileostomy surgery
2. Stoma output >20 mL/kg/day (high-output stoma)
3. Stoma output is collected in a stoma bag
4. Parent or legal guardian is present and able to provide informed consent
Minimum age
0 Days
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prolapsed stoma in direct contact with the Stomal Sponge
2. Stoma not used for faecal diversion
3. Requirement for refeeding of stoma output
4. Clinically unstable as determined by the treating neonatal consultant
5. Use of any in-bag agents (e.g. gelling agents) in historical control infants

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The planned sample size is 15 neonates in the intervention group and 15 matched historical controls, for a total of 30 participants. This number was selected based on the expected volume of eligible neonatal stoma cases at the study site during a 6-month recruitment period. While a formal power calculation was not performed due to limited published data on leakage frequency in this population, the sample size is considered adequate to assess the study objectives and estimate effect sizes for future trials.

The primary outcome, defined as the number of unplanned stoma bag changes per infant-day, will be analysed using negative binomial regression. The primary predictor variable will be study period (post-implementation versus pre-implementation). The model will adjust for stoma type, gestational age band, and birth weight band. If differences in feeding status are observed between matched pairs, feed status (categorised using SRAMT-defined tiers) will be added as a covariate in a sensitivity model. Results will be reported as rate ratios with 95% confidence intervals.

Secondary outcomes will be analysed using methods appropriate to their distribution and structure. Mean stoma bag wear time, measured in hours, will be evaluated using analysis of covariance (ANCOVA) if residuals are approximately normally distributed, or rank-based ANCOVA if not. The occurrence of clinically significant peristomal skin breakdown will be assessed using logistic regression, adjusting for cohort and relevant neonatal characteristics. Parent experience scores from the TASSEL-ED Parent-Reported Survey will be analysed using paired t-tests or Wilcoxon signed-rank tests, depending on the normality of the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
31/03/2026
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 319540 0
Charities/Societies/Foundations
Name [1] 319540 0
Mater Foundation
Country [1] 319540 0
Australia
Primary sponsor type
Hospital
Name
Mater Mothers' Hospital Brisbane
Address
Country
Australia
Secondary sponsor category [1] 322043 0
None
Name [1] 322043 0
Address [1] 322043 0
Country [1] 322043 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318117 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 318117 0
Ethics committee country [1] 318117 0
Australia
Date submitted for ethics approval [1] 318117 0
29/07/2025
Approval date [1] 318117 0
Ethics approval number [1] 318117 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143166 0
Miss Mackenzie Boundy
Address 143166 0
Mater Hospital, Raymond Terrace, South Brisbane QLD 4101
Country 143166 0
Australia
Phone 143166 0
+61 468388121
Fax 143166 0
Email 143166 0
[email protected]
Contact person for public queries
Name 143167 0
Mackenzie Boundy
Address 143167 0
Mater Hospital, Raymond Terrace, South Brisbane QLD 4101
Country 143167 0
Australia
Phone 143167 0
+61 468388121
Fax 143167 0
Email 143167 0
[email protected]
Contact person for scientific queries
Name 143168 0
Mackenzie Boundy
Address 143168 0
Mater Hospital, Raymond Terrace, South Brisbane QLD 4101
Country 143168 0
Australia
Phone 143168 0
+61 468388121
Fax 143168 0
Email 143168 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: As this is a single-centre study involving a small neonatal population, individual participant data will not be shared to protect privacy and confidentiality.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form  [email protected]
Other  [email protected] TASSEL-ED Parent-Reported Survey
Study protocol  [email protected]


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.