Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy

Not Applicable

Completed

• Conditions: Surgical Site Infection; Surgical Wound Infection; Surgical Complication; Surgical Wound Dehiscence; Surgical Wound; Surgical Wound Haemorrhage; Surgical Wound, Healed
• Interventions: Other: Control group - standard wound dressing; Device: Incisional negative pressure wound therapy

• Registration Number: NCT05716490
• Lead Sponsor: Centro Hospitalar do Tâmega e Sousa

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-01-28
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-08
• Primary Completion: 2023-08-01
• Study Completion: 2023-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Control group - standard wound dressing	Control group which will cover surgical wound with conventional wound dressing
PICO	Incisional negative pressure wound therapy	Group that will use Pico® device for wound dressing
PREVENA	Incisional negative pressure wound therapy	Group that will use Prevena® device for wound dressing

Primary Outcome Measures

Name	Time	Method
Surgical site infection	30 days	Surgical site infection following emergency laparotomy

Secondary Outcome Measures

Name	Time	Method
Surgical site occurrences	30 days	Seroma, hematoma, wound dehiscence

Trial Locations

Locations (1)

Centro Hospitalar do Tâmega e Sousa; 🇵🇹 Penafiel, Porto, Portugal