The Effects of The Products Used In Nazogastric Tube Fixation

Marmara University

Status: Unknown

Conditions: Skin Injury

Treatments: Device: Water-based barrier tape; Device: Hydrocolloid barrier tape; Device: Silk tape

Study type: Interventional

Funder types: Other

Identifiers

NCT04802694

87982892-929

Details and patient eligibility

About

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."

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 4 to 6 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Water-based barrier tape

Experimental group

Description:

The infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube

Treatment:

Device: Water-based barrier tape

Hydrocolloid barrier tape

Experimental group

Description:

The infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube.

Treatment:

Device: Hydrocolloid barrier tape

Adhesive product

Active Comparator group

Description:

The silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube.

Treatment:

Device: Silk tape