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Hydrocolloid Dressings in Diaper Dermatitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07186907
Enrollment
44
Registered
2025-09-22
Start date
2017-11-13
Completion date
2018-03-17
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaper Dermatitis, Diaper Dermatitis Healing, Diaper Rash

Keywords

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

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.

Interventions

Hydrocolloid dressing was used for diaper dermatitis

DRUGZinc oxide cream %40

Zinc oxide cream was used in diaper dermatitis.

Sponsors

Gozde AKSUCU
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Days to 1 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in diaper dermatitis severity scoreBaseline, 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 dermatitisWithin 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026