None listed
Conditions
Brief summary
This study will evaluate whether using the Stomal Sponge, a soft, absorbent insert placed inside a stoma bag, can help reduce leakage and improve skin health in babies with high-output stomas. The study will be conducted in the Mater Mothers’ Neonatal Critical Care Unit in Brisbane and will involve 15 babies using the Stomal Sponge, compared with a group of 15 similar babies who did not use the sponge in the past. The researchers will measure how often stoma bags need to be changed due to leakage, how long the bags stay in place, and whether the skin around the stoma remains healthy. Parents will also be asked about their experience with stoma care. The Stomal Sponge is already approved for use in Australia and is being used in this study in line with its intended purpose. The study aims to assess its potential clinical benefits in a neonatal hospital setting.
Interventions
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
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.
Sponsors
Mater Mothers' Hospital Brisbane
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed