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Completed

NCT Number: NCT04802694

The Effects of The Products Used In Nazogastric Tube Fixation

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."

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Key information

Conditions

Skin Injury

Age range

4 week–6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Giresun University Women and Children's Hospital

Giresun, Turkey (Türkiye)

About this study

The study was planned as randomized controlled and experimental design to compare the efficiency of three different methods protecting skin deficiencies using adhesive products for 4-6 weeks infants. The universe of the study consisted of 4-6 weeks infants in neonatal and infants clinics of Giresun Women's and Children's Hospital between the dates of October 2020-2021. Power analysis was performed through G*Power (v3.1.7) programme in order to determine the number of the sample. At the beginning of the study, a pilot study was carried out with 15 participants from each of the groups and the effect size was calculated as d=0.672 regarding the assessment of skin condition scores and 108 participants in total should be included in the study as 36 participants for each groups in order to obtain 80% power in the level of α=0.05. Block randomization technique is applied in the study as a randomization method. "As for data collection "Infant desciption form" and "Neonatal Skin Condition Score Scale" is used. The scale is filled by two independent observer via double-blind method.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All the 4-6 weeks infants including interventional process and without any skin diseases

Exclusion criteria

  • 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

Treatment and study plan

Water-based barrier tape

Device

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.

Hydrocolloid barrier tape

Device

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.

Silk tape

Device

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.

Primary outcomes

  1. Water-based barrier tape

    Time frame: 24 hours

    To evaluate the skin integrity of the infants following the removal of silk adhesive from water-based barrier tape

  2. Hydrocolloid barrier tape

    Time frame: 24 hours

    To evaluate the skin integrity of the infants following the removal of silk adhesive from hydrocolloid barrier tape

  3. Adhesive tape

    Time frame: 24 hours

    To evaluate the skin integrity of the infants following the removal of silk adhesive from infants skin without any barrier tape

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Comparison of The Effects of The Products Used In Nazogastric Tube Fixation on Skin Integrity In Babies: Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2021
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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