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NCT Number: NCT07392294

Foam Dressing Versus Silver Foam Dressing for Pediatric Tracheostomy Wound Care

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.

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Key information

Conditions

Tracheostomy Complication Pressure Ulcer Pressure Ulcer (PU) Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Surgical Wound Wounds and Injuries

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem Atasehir Hastanesi

Istanbul, Ataturk Mahallesi, 34660, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Foam Dressing

Device

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.

Silver-Impregnated Foam Dressing

Device

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.

Primary outcomes

  1. Incidence of Peristomal Complications

    Time frame: 30 days postoperatively

    Measure DescriptionOverall rate of peristomal complications including infection, pressure ulcer, granulation tissue, and skin necrosis. Measured as percentage of patients developing any complication.

Secondary outcomes

  1. Braden Q Risk Assessment Scale Score

    Time frame: Postoperative days 1, 7, 14, and 21

    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.

  2. Pressure Ulcer Severity by NPIAP Classification

    Time frame: 30 days postoperatively

    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).

Sponsors and collaborators

Lead sponsor

Acibadem Atasehir Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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