The Effects of The Products Used In Nazogastric Tube Fixation
Comparison of The Effects of The Products Used In Nazogastric Tube Fixation on Skin Integrity In Babies: Randomized Controlled Study
1 other identifier
interventional
108
1 country
1
Brief Summary
The present study was planned to compare the effect of products, used in the fixation of nasogastric tube, on skin integrity of 4-6 weeks infants hospitalized at neonatal and infant units. The hypothesis of the study is "Water-based barrier tape is more effective to protect skin integrity than hydrocolloid barrier tape."
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 2, 2020
CompletedFirst Submitted
Initial submission to the registry
March 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2021
CompletedApril 8, 2021
April 1, 2021
1 year
March 15, 2021
April 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Water-based barrier tape
To evaluate the skin integrity of the infants following the removal of silk adhesive from water-based barrier tape
24 hours
Hydrocolloid barrier tape
To evaluate the skin integrity of the infants following the removal of silk adhesive from hydrocolloid barrier tape
24 hours
Adhesive tape
To evaluate the skin integrity of the infants following the removal of silk adhesive from infants skin without any barrier tape
24 hours
Study Arms (3)
Water-based barrier tape
EXPERIMENTALThe infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube
Hydrocolloid barrier tape
EXPERIMENTALThe infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube.
Adhesive product
ACTIVE COMPARATORThe silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube.
Interventions
The infants in experiment 1 group will be applied water-based barrier tape. The area will be covered by water-based barrier tape to fix nasogastric tube and after waiting 1 minute for drying up it will be fastened by silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the water-based barrier tape, the skin integrity of the infants will be evaluated through "Neonatal Skin Condition Score Scale" and the score will be recorded in the chart. Water-based barrier tape will be applied to the area every time the plaster will be changed and current skin condition score will be noted to the chart.
As for experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube. The hydrocolloid barrier tape, which was cut and shaped appropriately beforehand, will be applied to the area in order to stabilize the nasogastric tube and the tube will be stabilized with silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the hydrocolloid barrier tape, the skin integrity of the infants will be evaluated through "Neonatal Skin Condition Score Scale" . Since the hydrocolloid barrier tape can stay on the skin for 7 days and be transparent, the assessment of skin condition will be realized for 7 days and noted down to the chart.
The silk tape used in clinic routinely will be used for control group infants to fix the nasogastric tube without any barrier. The silk tape will be 5cm long and it will be changed in every 24 hours. Following the removal of silk tape, the skin integrity of the infants will be evaluated through "Neonatal Skin Condition Score Scale" and the score will be recorded in the chart.
Eligibility Criteria
You may qualify if:
- All the 4-6 weeks infants including interventional process and without any skin diseases
You may not qualify if:
- The infants receiving treatment without any interventional process
- Those having a skin disease
- Those infants having PICC and SVK catheters and do not meet the required criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Giresun University Women and Children's Hospital
Giresun, Turkey (Türkiye)
Related Publications (1)
Lund CH, Osborne JW. Validity and reliability of the neonatal skin condition score. J Obstet Gynecol Neonatal Nurs. 2004 May-Jun;33(3):320-7. doi: 10.1177/0884217504265174.
PMID: 15180195RESULT
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc.Prof
Study Record Dates
First Submitted
March 15, 2021
First Posted
March 17, 2021
Study Start
October 2, 2020
Primary Completion
October 2, 2021
Study Completion
October 2, 2021
Last Updated
April 8, 2021
Record last verified: 2021-04