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| ID | Type | Description | Link |
|---|---|---|---|
| 2022/001). | Other Grant/Funding Number | Science Research Program of Health Sciences University. |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Foam Dressing | Active Comparator | Patients received standard foam dressing for tracheostomy wound care (Group A, n=25) |
|
| Silver-Impregnated Foam Dressing | Experimental | Patients received silver-impregnated foam dressing for tracheostomy wound care (Group B, n=25) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asli SAHIN YILMAZ, professor | Umraniye Education and Research Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acibadem Atasehir Hastanesi | Istanbul | Ataturk Mahallesi | 34660 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42146117 | Derived | 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:e70436. doi: 10.1002/lio2.70436. eCollection 2026 Jun. |
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Individual participant data will not be shared.
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |
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| 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. |
|
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 |