Hydrocolloid Dressings in Diaper Dermatitis

September 18, 2025 updated by: Gozde AKSUCU

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Bakırköy
      • Istanbul, Bakırköy, Turkey (Türkiye), 34140
        • Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrocolloid dressing
Device: Hydrocolloid dressing
Hydrocolloid dressing was used for diaper dermatitis
Active Comparator: Zinc oxide cream (Control group)
Drug: Zinc oxide cream %40
Zinc oxide cream was used in diaper dermatitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 24 hours, 48 hours, and 72 hours after initiation of intervention.
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.
Within 72 hours after initiation of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gozde AKSUCU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2017

Primary Completion (Actual)

March 13, 2018

Study Completion (Actual)

March 17, 2018

Study Registration Dates

First Submitted

September 11, 2025

First Submitted That Met QC Criteria

September 18, 2025

First Posted (Actual)

September 22, 2025

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-15-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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