Foam Dressing Versus Silver Foam Dressing for Pediatric Tracheostomy Wound Care

Comparison of Foam Dressing Versus Silver-Impregnated Foam Dressing for Prevention of Peristomal Complications in Pediatric Tracheostomy: A Prospective Randomized Controlled Trial Using Validated Assessment Tools

This study compares two types of wound dressings used after tracheostomy surgery in children: standard foam dressing and silver-impregnated foam dressing.

Tracheostomy is a surgical procedure that creates an opening in the neck to help children breathe. Skin problems around the tracheostomy site are common, occurring in up to 29% of pediatric patients.

The purpose of this study is to determine if silver-impregnated foam dressing is better than standard foam dressing in preventing skin complications around the tracheostomy site.

Fifty children (ages 0-18 years) undergoing tracheostomy surgery were randomly assigned to receive either standard foam dressing or silver-impregnated foam dressing. All patients received the same standardized wound care. Patients were followed for one month after surgery.

The main outcome measured was the rate of skin complications. Secondary outcomes included pressure ulcer risk assessment using the Braden Q Scale and wound staging using the National Pressure Injury Advisory Panel classification.

Study Overview

• Status: Completed
• Conditions: Surgical Wound; Tracheostomy Complication; Pressure Ulcer (PU)
• Intervention / Treatment: Device: Standard Foam Dressing; Device: Silver-Impregnated Foam Dressing

Detailed Description

Peristomal skin complications represent a significant concern following pediatric tracheostomy, with reported incidence rates up to 29%. These complications include pressure ulcers, infections, granulation tissue, and skin breakdown.

This prospective randomized controlled trial was conducted at a single tertiary care center. Fifty pediatric patients undergoing elective tracheostomy were enrolled and randomly assigned to one of two groups:

Group A (n=25): Standard foam dressing Group B (n=25): Silver-impregnated foam dressing

All patients received a standardized postoperative care protocol including:

• Velcro ties with foam padding for tube securement
• Daily wound assessment
• Neutral head positioning for ventilated patients
• Standardized dressing change criteria

Patients were assessed on postoperative days 1, 7, 14, 21, and 30. Pressure ulcer risk was evaluated using the Braden Q Risk Assessment Scale, and any pressure injuries were staged according to the National Pressure Injury Advisory Panel (NPIAP) classification system.

This is the first randomized controlled trial comparing these dressing types using validated, standardized assessment tools in pediatric tracheostomy patients.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ataturk Mahallesi
    • Istanbul, Ataturk Mahallesi, Turkey (Türkiye), 34660
      • Acibadem Atasehir Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric patients aged 0-18 years
• Undergoing elective tracheostomy
• Tracheostomy performed by the pediatric otolaryngology team
• Followed in neonatal or pediatric intensive care units

Exclusion Criteria:

• Patients over 18 years of age
• Emergency tracheostomy
• Percutaneous tracheostomy
• Pre-existing skin diseases
• History of head and neck surgery
• Tracheostomy performed during airway reconstruction surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Foam Dressing; Patients received standard foam dressing for tracheostomy wound care (Group A, n=25)	Device: Standard Foam Dressing; DescriptionStandard foam dressing applied under tracheostomy cannula. Dressings were changed when 75% saturated with secretions or left in place up to 7 days if dry.
Experimental: Silver-Impregnated Foam Dressing; Patients received silver-impregnated foam dressing for tracheostomy wound care (Group B, n=25)	Device: Silver-Impregnated Foam Dressing; Silver-impregnated foam dressing applied under tracheostomy cannula. Dressings were changed when 75% saturated with secretions or left in place up to 7 days if dry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Peristomal Complications	Measure DescriptionOverall rate of peristomal complications including infection, pressure ulcer, granulation tissue, and skin necrosis. Measured as percentage of patients developing any complication.	30 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Braden Q Risk Assessment Scale Score	Measure DescriptionPressure ulcer risk assessment using Braden Q Scale (score range 7-28). Lower scores indicate higher risk: ≤12 high risk, 13-15 moderate risk, ≥16 no risk.	Postoperative days 1, 7, 14, and 21
Pressure Ulcer Severity by NPIAP Classification	Measure DescriptionPressure ulcer staging according to National Pressure Injury Advisory Panel (NPIAP) classification system: Stage 1 (non-blanchable erythema), Stage 2 (partial-thickness skin loss), Stage 3 (full-thickness skin loss), Stage 4 (full-thickness tissue loss).	30 days postoperatively

Collaborators and Investigators

• Sponsor: Acibadem Atasehir Hospital
• Investigators: Study Chair: Asli SAHIN YILMAZ, professor, Umraniye Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Children; Wound care; Pressure ulcer prevention; Foam dressing; Pediatric tracheostomy; Silver-impregnated dressing; Peristomal complications; Braden Q Scale
• Additional Relevant MeSH Terms: Wounds and Injuries; Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Surgical Wound; Pressure Ulcer
• Other Study ID Numbers: 85-2021; 2022/001). (Other Grant/Funding Number: Science Research Program of Health Sciences University.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No