Surgical site infection Orthopaedic fracture Wound complication following operative fracture fixation Negative-Pressure Wound Therapy Surgical Wound Infection Fractures, Bone Fracture Fixation, Internal Wound Healing Quality of Life Postoperative Complications Randomized Controlled Trial
Conditions
Interventions
After wound closure, occlusive drape (Ioban
3M) was applied 2 cm along each incision side. Non-adherent paraffin gauze (Bactigras
Smith &
Nephew) was placed over the incision, followed by a 1-inch polyurethane foam strip with a 16-French nasogastric tube as suction conduit, sealed with occlusive drape. Continuous negative pressure of -7
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
Incisional negative pressure wound therapy (iNPWT),Conventional wound dressing
Sponsors
Department of Orthopaedic Surgery, Police General Hospital, Bangkok, Thailand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Single-system musculoskeletal injury requiring operative internal fixation 2. Presence of at least one SSI risk factor as defined by the 2017 International Multidisciplinary Consensus on closed incision negative pressure therapy (Willy et al., Int Wound J 2017), including: Patient-related risk factors: - Diabetes mellitus - Obesity (BMI >30 kg/m2) - Active tobacco use - Hypoalbuminaemia - Corticosteroid use - Active alcoholism - Chronic renal insufficiency - Chronic obstructive pulmonary disease (COPD) - Hypertension - Advanced age (>80 years) Wound- and procedure-related risk factors: - High-tension incision - Traumatized soft tissue - Wound contamination - Open fracture - Repeated incisions at the same site - Prolonged operative time (>120 minutes) - High-risk anatomical site (calcaneus or tibial plateau) - Fasciotomy at same admission - Emergency surgical procedure
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Incarceration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical site infection Within 180 days postoperatively Rate of SSI classified per CDC surveillance definitions (superficial incisional, deep incisional, or organ/space); assessed by attending surgeon blinded to group allocation | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound dehiscence Postoperative days 3, 5, 7, 10, 14, and 30 Proportion of patients with wound dehiscence assessed by clinical examination using World Union of Wound Healing Societies (WUWHS) criteria,Dressing-related complications Postoperative day 3 Proportion of patients with blister formation, skin maceration, or device-associated skin injury assessed by clinical examination,Length of hospital stay At discharge Number of days from surgery to discharge recorded from hospital records,Health-related quality of life Postoperative days 5, 30, 90, and 180 Mean EQ-5D-5L Visual Analogue Scale score (0-100; higher scores indicate better health) assessed by patient self-report,Scar quality Postoperative days 30, 90, and 180 Mean POSAS 2.0 patient scale score (lower scores indicate better scar quality) assessed by patient self-report | — |
Countries
Thailand
Contacts
Public ContactAnuwat Thanasornwichaya
Department of Orthopaedic Surgery, Police General Hospital
Outcome results
None listed