Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. A Randomized Prospective Clinical Trial.

Study Overview
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Brief Summary
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Negative pressure wound closure technique (NPWT) has been widely introduced in different clinical settings. Most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen. NPWT as a prophylactic effort to prevent complications of high risk surgical wounds has recently been introduced, but the concept is still lacking clinical evidence in terms of clinical effectiveness and cost effectiveness. In this randomized, multi centric study investigators aim to compare prophylactic negative pressure wound closure (ciNPWT) with traditional, dry wound dressing at high infection risk laparotomy wounds.

Detailed Description
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The aim is to compare ciNPWT (closed incisional negative pressure wound dress) technique to the traditional, dry wound dressing technique at high infection risk laparotomy wounds. Control arm will be treated as usual: sterile gauze or high-absorbing surgical wound dress. Experimental arm will be dressed with: one layer of silver-containing, impregnated mesh laxer (Atrauman® Ag - Hartmann) directly placed on the primary closed wound, one layer of alcohol-soaked foam (VivanoMed® White Foam - Hartmann) and sufficient-size sealant film (Hydrofilm® - Hartmann). A negative pressure of -90 Hgmm will be administered in a continuous mode over 5 days postoperatively. Surgical site infection and abdominal wall dehiscence rate will be assessed, as well as cost effectiveness will be calculated at both arms.

Official Title
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Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. Randomized Prospective Clinical Trial.

Conditions
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Surgical Wound, Wound Dehiscence, Surgical, Surgical Site Infection, Dehiscence of Internal Surgical Wound

Intervention / Treatment
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* Device: Prophylactic negative pressure wound dressing after laparotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High risk laparotomy patients. SSI risk at least 3x higher than normal rate (6-8%) Surgical wound type III or IV.. Exclusion Criteria: Patients not giving informed consent. Patients requiring open abdominal wound care. Patients with abdominal wall malignancy, Patients with peritoneal carcinomatosis, Patients who are planned for second look laparotomy within 5 days, Patients with less thank 3 month life expectancy. Patients who are operated with existing wound infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: 50-50% randomisation into interventional (ciNPWT) and control (traditionaltreatment) groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ciNPWT<br>Prophylactic negative pressure wound dress (Hartmann) is set up for 5 days right after operation. Continous -90 Hgmm negative pressure mode selected. No change of wound dress until 5 days completed. | Device: Prophylactic negative pressure wound dressing after laparotomy<br>* Five days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound.<br>|
| No Intervention: Traditional wound dressing<br>Control group with traditional, dry laparotomy wound dressing. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Surgical site infection requiring wound re-opening (suture removal) and open wound treatment. (Clavien-Dindo 2) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full thickness abdominal wall dehiscence, requiring re-operation | Full thickness abdominal wall dehiscence, requiring re-operation | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical site infection, cost effectiveness, negative pressure wound closure