Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy (OPTIWOUND)

Centro Hospitalar do Tâmega e Sousa

Status: Completed

Conditions: Surgical Wound, Healed; Surgical Wound; Surgical Site Infection; Surgical Complication; Surgical Wound Haemorrhage; Surgical Wound Dehiscence; Surgical Wound Infection

Treatments: Device: Incisional negative pressure wound therapy; Other: Control group - standard wound dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT05716490

29/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 3 patient groups

Standard

Active Comparator group

Description:

Control group which will cover surgical wound with conventional wound dressing

Treatment:

Other: Control group - standard wound dressing

PICO

Experimental group

Description:

Group that will use Pico® device for wound dressing

Treatment:

Device: Incisional negative pressure wound therapy

PREVENA

Experimental group

Description:

Group that will use Prevena® device for wound dressing

Treatment:

Device: Incisional negative pressure wound therapy