Hydrocolloid Dressings in Diaper Dermatitis

NCT07186907 | Completed

• 1 other identifier: 2017-15-12
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diaper Dermatitis; Diaper Dermatitis Healing; Diaper Rash

Keywords

diaper dermatitis; hydrocolloid dressing; zinc oxide; NICU; quasi-experimental

Outcome Measures

Primary Outcomes (2)

• Change in diaper dermatitis severity score

  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

  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.

Study Arms (2)

Hydrocolloid dressing

EXPERIMENTAL

Device: Hydrocolloid dressing

Zinc oxide cream (Control group)

ACTIVE COMPARATOR

Drug: Zinc oxide cream %40

Interventions

Hydrocolloid dressing DEVICE

Hydrocolloid dressing was used for diaper dermatitis

Hydrocolloid dressing

Zinc oxide cream %40 DRUG

Zinc oxide cream was used in diaper dermatitis.

Zinc oxide cream (Control group)

Eligibility Criteria

• Age: 0 Days - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gozde AKSUCU: lead

Study Sites (1)

Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, Bakırköy, 34140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diaper Rash

Interventions

Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor (PhD)

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 22, 2025
• Study Start: November 13, 2017
• Primary Completion: March 13, 2018
• Study Completion: March 17, 2018
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)