Foam Dressing Versus Silver Foam Dressing for Pediatric Tracheostomy Wound Care

NCT07392294 | Completed

• 2 other identifiers: 85-20212022/001).
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Wound; Tracheostomy Complication; Pressure Ulcer (PU)

Keywords

Pediatric tracheostomy; Foam dressing; Silver-impregnated dressing; Pressure ulcer prevention; Peristomal complications; Wound care; Braden Q Scale; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Braden Q Risk Assessment Scale Score

  Postoperative days 1, 7, 14, and 21

• Pressure Ulcer Severity by NPIAP Classification

  30 days postoperatively

Study Arms (2)

Standard Foam Dressing

ACTIVE COMPARATOR

Patients received standard foam dressing for tracheostomy wound care (Group A, n=25)

Device: Standard Foam Dressing

Silver-Impregnated Foam Dressing

EXPERIMENTAL

Patients received silver-impregnated foam dressing for tracheostomy wound care (Group B, n=25)

Device: Silver-Impregnated Foam Dressing

Interventions

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.

Silver-Impregnated Foam Dressing

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.

Standard Foam Dressing

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem Atasehir Hospital: lead

Study Sites (1)

Acibadem Atasehir Hastanesi

Istanbul, Ataturk Mahallesi, 34660, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer; Surgical Wound

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Asli SAHIN YILMAZ, professor

  Umraniye Education and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: March 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: August 30, 2024
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)