NCT05716490

Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy

Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy: A Multi-arm Randomized Prospective Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Centro Hospitalar do Tâmega e Sousa · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Surgical Complication
• Surgical Wound Dehiscence
• Surgical Wound Haemorrhage
• Surgical Wound, Healed

Interventions

Type	Name	Description
DEVICE	Incisional negative pressure wound therapy	Application of negative pressure wound therapy for prophylaxis of surgical site occurrences
OTHER	Control group - standard wound dressing	Covering of surgical wound with standard wound dressing

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-08-01
• Completion: 2023-09-01
• First posted: 2023-02-08
• Last updated: 2023-11-13

Locations

1 site across 1 country: Portugal