None listed
Conditions
Brief summary
Preterm infants, particularly those born at less than 26 weeks gestational age, are highly vulnerable to skin injuries, which can lead to colonisation by pathogenic bacteria, sepsis, pain, and lifelong scarring. StrataCTX is a silicone polymer-based film-forming gel that creates a protective layer on the skin, promoting (re-)epithelialisation and healing. This gel shows promise in preventing skin injuries in preterm infants. The primary objective of this pilot trial is to evaluate the safety, feasibility, and preliminary efficacy of StrataCTX in preventing skin injuries in preterm infants compared to our standard care, topical coconut oil.
Interventions
This trial will compare the current standard extremely preterm skin care in our NICU, to the investigational product, StrataCTX. StrataCTX is included in the Australian Register of Therapeutic Goods (#317640) as a skin semi-occlusive dressing for the treatment of dry skin and cutaneous rashes, and is suitable for children, including infants, and people with sensitive skin.
Assessment: Infants in the trial will be monitored daily for 14 days post birth. Skin condition will be assessed daily usin
This trial will compare the current standard extremely preterm skin care in our NICU, to the investigational product, StrataCTX. StrataCTX is included in the Australian Register of Therapeutic Goods (#317640) as a skin semi-occlusive dressing for the treatment of dry skin and cutaneous rashes, and is suitable for children, including infants, and people with sensitive skin. Assessment: Infants in the trial will be monitored daily for 14 days post birth. Skin condition will be assessed daily using standardized neonatal skin condition scores (NSCS) (performed each shift as part of routine care for every NICU patient), with additional photographic documentation. Skin microbiome: Superficial skin swabs will be collected from the neck, chest and abdomen on days 1 (prior to start of intervention), 8-10 (following completion of 7 days intervention) and 14-16 (wash-out period). Intervention: StrataCTX, a silicon polymer-based gel, produced by Swiss skin care specialist Stratpharma which dries into a thin, transparent, protective layer that bonds lightly to the skin and provides an optimised environment for healing and re-epithelisation. The intervention will be applied by a trained research nurse dedicated to the project. The StrataCTX is applied to the neck and frontal torso of the infant 2-4 times daily, starting within 24h from birth, for the first 7 days of life (time of highest risk of skin injuries to torso). A minimum amount of StrataCTX to create a thin film that dries within ~5 min (required volume ca. 1-1.5 ml) will be applied. Other body areas will receive routine treatment with topical coconut oil. For infants < 25 weeks GA, the gel is applied withn 24 hours of birth, 4 x daily. For infants >= 25 weeks GA, the gel is applied twice daily. The application of gel is recorded every day (4 times, 3 times, 2 times, 1 time, not applied. The reason is noted if application is once or less). Daily photographs are taken of skin condition and daily NSCS recorded for 14 days post admission.
Sponsors
Child and Adolescent Health Service (WA)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 26 Weeks
Healthy volunteers
No
Inclusion criteria
a) Infants born at less than 26 weeks gestational age and within 24h from birth. b) Parental written consent obtained.
Exclusion criteria
a) Infants with congenital skin disorders or surgical conditions contraindicating topical treatment. b) Infants whose parents do not provide consent.
Outcome results
None listed