Tracheostomy ComplicationNCT07392294
Foam Dressing Versus Silver Foam Dressing for Pediatric Tracheostomy Wound Care
A study testing Standard Foam Dressing and Silver-Impregnated Foam Dressing in people with Tracheostomy Complication and Pressure Ulcer (PU), run by Acibadem Atasehir Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Tracheostomy Complication, Pressure Ulcer (PU), Surgical Wound
- What is being tested?
- Standard Foam Dressing and Silver-Impregnated Foam Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients aged 0-18 years
- Undergoing elective tracheostomy
- Tracheostomy performed by the pediatric otolaryngology team
- Followed in neonatal or pediatric intensive care units
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Atasehir Hastanesi
Istanbul, Ataturk Mahallesi, 34660
About this study
Official 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
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.
Read more
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.
Read the 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.
- Being tested
- Standard Foam Dressing, Silver-Impregnated Foam Dressing
- Keywords
- Pediatric tracheostomy, Foam dressing, Silver-impregnated dressing, Pressure ulcer prevention, Peristomal complications, Wound care, Braden Q Scale, Children
- Medical subject headings
- Pressure Ulcer, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Foam DressingDevice
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 DressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Foam Dressing | Active comparator | Patients received standard foam dressing for tracheostomy wound care (Group A, n=25) Receives: Device: Standard Foam Dressing |
| Silver-Impregnated Foam Dressing | Experimental | Patients received silver-impregnated foam dressing for tracheostomy wound care (Group B, n=25) Receives: Device: Silver-Impregnated Foam Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days postoperatively
Secondary outcomes (2)
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.
Measured: 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).
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Mar 2022
- Primary completion30 Jul 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem Atasehir Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP SAHIN ONDER, Acibadem Atasehir Hospital
- Investigators
- Asli SAHIN YILMAZ, professor, Study chair, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392294
- Sponsor's protocol ID
- 85-2021
- Other IDs
- 2022/001).
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Bostanci SA, Onder SS, Surmeli M, Atay G, Sahin O, Yilmaz AAS. Foam Versus Silver-Impregnated Foam Dressings for Pediatric Tracheostomy: A Randomized Trial. Laryngoscope Investig Otolaryngol. 2026 May 14;11(3):e70436. doi: 10.1002/lio2.70436. eCollection 2026 Jun.
PubMed 42146117
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07392294
- Acronym / sponsor ID
- 85-2021
- Keywords
- Pediatric tracheostomy, Foam dressing, Silver-impregnated dressing, Pressure ulcer prevention, Peristomal complications, Wound care, Braden Q Scale, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Acibadem Atasehir HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Foam Dressing | Active comparator | Device: Standard Foam DressingPatients received standard foam dressing for tracheostomy wound care (Group A, n=25) |
| Silver-Impregnated Foam Dressing | Experimental | Device: Silver-Impregnated Foam DressingPatients received silver-impregnated foam dressing for tracheostomy wound care (Group B, n=25) |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pediatric patients aged 0-18 years
- Undergoing elective tracheostomy
- Tracheostomy performed by the pediatric otolaryngology team
- Followed in neonatal or pediatric intensive care units
Key exclusion criteria (6 listed)
- Patients over 18 years of age
- Emergency tracheostomy
- Percutaneous tracheostomy
- Pre-existing skin diseases
- History of head and neck surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Foam DressingDescriptionStandard foam dressing applied under tracheostomy cannula. Dressings were changed when 75% saturated with secretions or left in place up to 7 days if dry. | Device | Standard Foam Dressing |
| Silver-Impregnated Foam DressingSilver-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. | Device | Silver-Impregnated Foam Dressing |
Primary outcome
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.
2 secondary outcomes
Braden Q Risk Assessment Scale Score
Time frame: Postoperative days 1, 7, 14, and 21
Pressure Ulcer Severity by NPIAP Classification
Time frame: 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 42146117Bostanci SA, Onder SS, Surmeli M, Atay G, Sahin O, Yilmaz AAS. Foam Versus Silver-Impregnated Foam Dressings for Pediatric Tracheostomy: A Randomized Trial. Laryngoscope Investig Otolaryngol. 2026 May 14;11(3):e70436. doi: 10.1002/lio2.70436. eCollection 2026 Jun.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
Related trials for Tracheostomy Complication
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
RecruitingObservational study
Increased Body Temperature Post Tracheostomy: a Retrospective Study
Tracheostomy Complication
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Outcomes After Tracheal Cannula Removal
Tracheostomy
RecruitingObservational study
Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.
Anesthesia Complication, Tracheostomy Complications
RecruitingObservational study
"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?"
Surveillance, Endoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asli SAHIN YILMAZ, professor study chair
Umraniye Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Foam Dressing and Silver-Impregnated Foam Dressing in people with Tracheostomy Complication and Pressure Ulcer (PU), run by Acibadem Atasehir Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Peristomal Complications (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07392294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.