Pressure Ulcer (PU), Surgical Wound, Tracheostomy Complication
Conditions
Keywords
Pediatric tracheostomy, Foam dressing, Silver-impregnated dressing, Pressure ulcer prevention, Peristomal complications, Wound care, Braden Q Scale, Children
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.
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.
Interventions
DEVICEStandard 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.
DEVICESilver-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.
Sponsors
Acibadem Atasehir Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Peristomal Complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Braden Q Risk Assessment Scale Score | 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. |
| Pressure Ulcer Severity by NPIAP Classification | 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). |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRAsli SAHIN YILMAZ, professor
Umraniye Education and Research Hospital
Outcome results
None listed