Hydrocolloid Dressings in Diaper Dermatitis

Gozde AKSUCU

Status: Completed

Conditions: Diaper Dermatitis Healing; Diaper Rash; Diaper Dermatitis

Treatments: Device: Hydrocolloid dressing; Drug: Zinc oxide cream %40

Study type: Interventional

Funder types: Other

Identifiers

NCT07186907

2017-15-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Hydrocolloid dressing

Experimental group

Treatment:

Device: Hydrocolloid dressing

Zinc oxide cream (Control group)

Active Comparator group

Treatment:

Drug: Zinc oxide cream %40