The Effects of The Products Used In Nazogastric Tube Fixation

Not Applicable

• Conditions: Skin Injury
• Interventions: Device: Water-based barrier tape; Device: Hydrocolloid barrier tape; Device: Silk tape

• Registration Number: NCT04802694
• Lead Sponsor: Marmara University

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."

Detailed Description

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.

Study Timeline

• Study Start: 2020-10-02
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-03
• Last Update Posted: 2021-04-08
• Primary Completion: 2021-10-02
• Study Completion: 2021-10-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water-based barrier tape	Water-based barrier tape	The infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube
Hydrocolloid barrier tape	Hydrocolloid barrier tape	The infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube.
Adhesive product	Silk tape	The silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube.

Primary Outcome Measures

Name	Time	Method
Water-based barrier tape	24 hours	To evaluate the skin integrity of the infants following the removal of silk adhesive from water-based barrier tape
Hydrocolloid barrier tape	24 hours	To evaluate the skin integrity of the infants following the removal of silk adhesive from hydrocolloid barrier tape
Adhesive tape	24 hours	To evaluate the skin integrity of the infants following the removal of silk adhesive from infants skin without any barrier tape

Trial Locations

Locations (1)

Giresun University Women and Children's Hospital; 🇹🇷 Giresun, Turkey