The Effects of The Products Used In Nazogastric Tube Fixation

Sponsor
Marmara University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04802694
Collaborator
(none)
108
1
3
12
9

Study Details

Study Description

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."

Condition or Disease Intervention/Treatment Phase
  • Device: Water-based barrier tape
  • Device: Hydrocolloid barrier tape
  • Device: Silk tape
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Comparison of The Effects of The Products Used In Nazogastric Tube Fixation on Skin Integrity In Babies: Randomized Controlled Study
Actual Study Start Date :
Oct 2, 2020
Anticipated Primary Completion Date :
Oct 2, 2021
Anticipated Study Completion Date :
Oct 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Device: Water-based barrier tape
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.

Experimental: Hydrocolloid barrier tape

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

Device: Hydrocolloid barrier tape
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.

Active Comparator: Adhesive product

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

Device: Silk tape
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Hydrocolloid barrier tape [24 hours]

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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Weeks to 6 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Giresun University Women and Children's Hospital Giresun Turkey

Sponsors and Collaborators

  • Marmara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
cagri covener ozcelik, Assoc.Prof, Marmara University
ClinicalTrials.gov Identifier:
NCT04802694
Other Study ID Numbers:
  • 87982892-929
First Posted:
Mar 17, 2021
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by cagri covener ozcelik, Assoc.Prof, Marmara University

Study Results

No Results Posted as of Apr 8, 2021