Umbilical Cord Care in Term Neonates: The Role of Wondaleaf Adhesive Pouch (WLAP)
Condition: Umbilical Cord Infection; Umbilical Sepsis; Neonatal Sepsis
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis
Study type: Interventional

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.
    

Intervention name(s): Adhesive pouch
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Wondaleaf adhesive pouch (WLAP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Umbilical cord care; Omphalitis; Neonatal sepsis; Barrier dressing