Hydrocolloid Dressings in Diaper Dermatitis

NCT ID: NCT07186907

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-13
• Study Completion Date: 2018-03-17

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.

Conditions

Diaper Dermatitis; Diaper Dermatitis Healing; Diaper Rash

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydrocolloid dressing

Group Type: EXPERIMENTAL

Hydrocolloid dressing

Intervention Type: DEVICE

Hydrocolloid dressing was used for diaper dermatitis

Zinc oxide cream (Control group)

Group Type: ACTIVE_COMPARATOR

Zinc oxide cream %40

Intervention Type: DRUG

Zinc oxide cream was used in diaper dermatitis.

Interventions

Hydrocolloid dressing

Hydrocolloid dressing was used for diaper dermatitis

Intervention Type: DEVICE

Zinc oxide cream %40

Zinc oxide cream was used in diaper dermatitis.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gozde AKSUCU

OTHER

Sponsor Role: lead

Responsible Party

Gozde AKSUCU

Assistant Professor (PhD)

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, Bakırköy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2017-15-12

Identifier Type: -

Identifier Source: org_study_id