Clinical trial NCT05716490: Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy
Official title: Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy: A Multi-arm Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Surgical Wound
Surgical Wound Infection
Surgical Complication
Surgical Wound Dehiscence
Surgical Wound Haemorrhage
Surgical Wound, Healed
Keywords: iNPWT
Incision negative pressure wound therapy
emergency laparotomy
general surgery
surgical site infection
Lead sponsor: Centro Hospitalar do Tâmega e Sousa
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical site infection
timeFrame: 30 days
Secondary outcomes:
measure: Surgical site occurrences
timeFrame: 30 days
Other outcomes:
measure: Length of stay
timeFrame: 30 days
measure: Reinterventions
timeFrame: 30 days
measure: Adverse events related to devices
timeFrame: 30 days
measure: Surgical complications
timeFrame: 30 days
Locations:
city: Penafiel
country: Portugal
facility: Centro Hospitalar do Tâmega e Sousa
state: Porto
Study officials:
affiliation: Centro Hospitalar do Tâmega e Sousa
name: Marcelo J Costa, MD
role: PRINCIPAL_INVESTIGATOR
References: