Hydrocolloid Dressings in Diaper Dermatitis

Not Applicable

Completed

• Conditions: Diaper Dermatitis; Diaper Dermatitis Healing; Diaper Rash
• Interventions: Device: Hydrocolloid dressing; Drug: Zinc oxide cream %40

• Registration Number: NCT07186907
• Lead Sponsor: Gozde AKSUCU

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.

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 Timeline

• Study Start: 2017-11-13
• Primary Completion: 2018-03-13
• Study Completion: 2018-03-17
• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Hydrocolloid dressing	Hydrocolloid dressing	-
Zinc oxide cream (Control group)	Zinc oxide cream %40	-

Primary Outcome Measures

Name	Time	Method
Change in diaper dermatitis severity score	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.
Time to complete healing of diaper dermatitis	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.

Trial Locations

Locations (1)

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