Skip to main content
OpenTrials
Completed

NCT Number: NCT07186907

Hydrocolloid Dressings in Diaper Dermatitis

Diaper dermatitis (commonly known as diaper rash) is one of the most frequent skin problems in newborns and infants, especially in neonatal intensive care units (NICUs). This study was designed to compare two treatment approaches for diaper dermatitis: hydrocolloid dressings and a cream containing 40% zinc oxide. The severity of diaper rash was evaluated at the beginning of treatment and at 24, 48, and 72 hours of follow-up.

Completed

Looking for future studies?

Notify Me

Key information

Age range

0 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, Bakırköy, 34140, Turkey (Türkiye)

About this study

Diaper dermatitis (diaper rash) is a common skin problem in neonates and infants, often associated with prolonged exposure of the skin to moisture, urine, and stool. Infants hospitalized in neonatal intensive care units (NICUs) are particularly vulnerable due to frequent stools, immature skin, and exposure to irritants. This study was conducted to evaluate the effectiveness of hydrocolloid dressings compared with standard barrier cream containing 40% zinc oxide in the management of diaper dermatitis. A total of 44 infants hospitalized in a NICU and clinically diagnosed with diaper dermatitis were included. Infants were allocated into two groups: the intervention group received hydrocolloid dressings applied to the affected area, while the control group received zinc oxide cream. The severity of diaper dermatitis was assessed using a standardized clinical evaluation scale at baseline and at 24, 48, and 72 hours after initiation of the intervention. The primary aim was to compare changes in severity scores and healing time between the two treatment groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hospitalization in the NICU
  • Body weight greater than 1000 g at the start of the intervention
  • Gestational age above 26 weeks
  • Diaper dermatitis diagnosis confirmed by a clinician
  • Clinically stable condition at enrollment
  • Written informed consent obtained from parents or legal guardians

Exclusion criteria

  • Congenital skin anomalies
  • Dermatitis due to other dermatological conditions
  • Systemic bacterial or fungal infections
  • Receiving immunosuppressive treatment

Treatment and study plan

Hydrocolloid dressing

Device

Hydrocolloid dressing was used for diaper dermatitis

Zinc oxide cream %40

Drug

Zinc oxide cream was used in diaper dermatitis.

Primary outcomes

  1. Change in diaper dermatitis severity score

    Time frame: Baseline, 24 hours, 48 hours, and 72 hours after initiation of intervention.

    The severity of diaper dermatitis will be assessed using the Clinical Evaluation Scale for Characterization of the Severity of Diaper Dermatitis (Stamatas & Tierney, 2014). Scores range from 0 (no dermatitis) to 3.0 (severe dermatitis), with 0.5-point increments. Higher scores indicate greater severity.

  2. Time to complete healing of diaper dermatitis

    Time frame: Within 72 hours after initiation of intervention.

    Complete healing is defined as a diaper dermatitis score of "0" on the Clinical Evaluation Scale. The proportion of infants achieving complete healing within 72 hours will be compared between groups.

Sponsors and collaborators

Lead sponsor

Gozde AKSUCU

Other

Registry information

Official study title

Hydrocolloid Dressing for Diaper Dermatitis in NICU Hospitalized Neonates and Young Infants: A Quasi-Experimental Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

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.

Published trials that share one or more normalized conditions with this study.