Foam Dressing Versus Silver Foam Dressing for Pediatric Tracheostomy Wound Care

January 30, 2026 updated by: SERAP SAHIN ONDER, Acibadem Atasehir Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative days 1, 7, 14, and 21
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).
30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem Atasehir Hospital

Investigators

  • Study Chair: Asli SAHIN YILMAZ, professor, Umraniye Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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