NCT05569551

Umbilical Cord Care in Term Neonates: The Role of Wondaleaf Adhesive Pouch (WLAP)

Umbilical Cord Care in Term Neonates: The Revolutionized Role of Wondaleaf Adhesive Pouch (WLAP) in the Prevention of Neonatal Sepsis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: AIMST University Malaysia · Academic / Other
• Sex: All
• Age: 1 Hour – 2 Hours
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy of Wondaleaf Adhesive Pouch (WLAP) in the prevention of umbilical cord infection among full-term neonates. Methods: This is a prospective double-blinded randomized controlled trial on 218 term neonates in which 109 each was randomly assigned to interventional and conventional group. The Wondaleaf Adhesive Pouch (WLAP) dressings were applied to umbilical stumps of the term neonates in interventional group by trained midwife on the first day immediate after delivery. Mothers or caregivers were taught to observe the umbilical stump the subsequent days till the stump detached. The observations are supported by photographic images taken by caregiver and evaluated by the trial team and reporting inflammation with immediately removal of WLAP or otherwise no sign of infection till the detachment of stump.

Detailed description

Background: Neonatal death was the serious global burden with three-quarter of it was attributable to neonatal sepsis. It was estimated that the annual incidence cases have reached 1.3 million and posed significant economic impact to many low-income and middle-income countries. The purpose of this study is to evaluate the efficacy of Wondaleaf Adhesive Pouch (WLAP) in the prevention of umbilical cord infection among full-term neonates. Methods: This is a prospective double-blinded randomized controlled trial conducted in one hospital located in state of Kedah, Malaysia on 218 term neonates in which 109 each was randomly assigned to interventional and conventional group. The Wondaleaf Adhesive Pouch (WLAP) dressings were applied to umbilical stumps of the term neonates in interventional group by trained midwife on the first day immediate after delivery. Mothers or caregivers will be taught to observe the umbilical stump the subsequent days till the stump detached. The observations are supported by photographic images taken by caregiver to be evaluated by the trial team and reporting inflammation with immediately removal of WLAP or otherwise no sign of infection till the detachment of stump. Results and conclusion will be reported after completion of the study.

Conditions

• Umbilical Cord Infection
• Umbilical Sepsis
• Neonatal Sepsis

Interventions

Type	Name	Description
DEVICE	Adhesive pouch	Is a barrier dressing categorized under class C medical device. It is used to seal up the umbilical stump to prevent contamination until its cord detachment. It has an adhesive film that sticks to skin with a centrally located non-adhesive pouch ensuring that zero pressure is applied on the umbilicus. It is made of polyurethane, the same material as transparent intravenous cannula dressings making it hypoallergenic waterproof and breathable.

Timeline

• Start date: 2022-11-15
• Primary completion: 2023-08-16
• Completion: 2023-09-16
• First posted: 2022-10-06
• Last updated: 2024-01-26

Locations

1 site across 1 country: Malaysia