Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Incisional negative pressure wound therapy
* Other: Control group - standard wound dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are enrolled chronologically at the time of surgery into a slot of a previously randomized table with the 3 interventional arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Control group which will cover surgical wound with conventional wound dressing | Other: Control group - standard wound dressing<br>* Covering of surgical wound with standard wound dressing<br>|
| Experimental: PICO<br>Group that will use Pico® device for wound dressing | Device: Incisional negative pressure wound therapy<br>* Application of negative pressure wound therapy for prophylaxis of surgical site occurrences<br>|
| Experimental: PREVENA<br>Group that will use Prevena® device for wound dressing | Device: Incisional negative pressure wound therapy<br>* Application of negative pressure wound therapy for prophylaxis of surgical site occurrences<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Surgical site infection following emergency laparotomy | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site occurrences | Seroma, hematoma, wound dehiscence | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iNPWT, Incision negative pressure wound therapy, emergency laparotomy, general surgery, surgical site infection