Surgical Site Infection, Surgical Wound, Surgical Wound Infection, Surgical Complication, Surgical Wound Dehiscence, Surgical Wound Haemorrhage, Surgical Wound, Healed
Conditions
Keywords
iNPWT, Incision negative pressure wound therapy, emergency laparotomy, general surgery, surgical site infection
Brief summary
The purpose of this study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (iNPWT)devices.
Detailed description
A multi-arm, randomized, single institution trial was conducted. All patients proposed for emergency laparotomy for different etiologies where considered eligible. Patients were enrolled following signature of informed consent. Excluded from this group were patients with recent previous interventions (laparotomy or minimally invasive surgery), patients not wishing a iNPWT device or patients with specific contraindications to any device. Later where excluded from the study patients on laparostomy, Intraoperative diagnosis of irreversible disease (Ex: Extensive mesenteric ischemia). Following enrollment patients were randomized to 3 groups - control group with standard dressings; PICO group with Pico® (Smith & Nephew Inc, Andover, MA) dressing and Prevena group using Prevena® (KCI USA, Inc., San Antonio, TX) dressing. Following admission the patients were monitored for surgical site occurrences and other complications by the investigation team until discharge. Subsequent 2 week post-operative evaluation (if patient had been discharged) was carried out in outpatient. A final consultation was made 30 days postoperatively.
Interventions
Application of negative pressure wound therapy for prophylaxis of surgical site occurrences
Covering of surgical wound with standard wound dressing
Sponsors
Study design
Intervention model description
Patients are enrolled chronologically at the time of surgery into a slot of a previously randomized table with the 3 interventional arms
Eligibility
Inclusion criteria
* All patients proposed for emergency laparotomy
Exclusion criteria
* Contra-indication for iNPWT * Irreversible disease diagnosis with expected short term mortality * Need for a staged procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | 30 days | Surgical site infection following emergency laparotomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site occurrences | 30 days | Seroma, hematoma, wound dehiscence |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | 30 days | post-operative length of stay |
| Reinterventions | 30 days | — |
| Adverse events related to devices | 30 days | — |
| Surgical complications | 30 days | — |
Countries
Portugal