Prevena™ Incision Management System vs Conventional Management for Wound Healing

Study Overview
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Brief Summary
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Comparison in abdominal wound healing after contaminated or dirty surgery with incisional negative pressure wound therapy versus standard dressing.

Detailed Description
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All patients submitted to contaminated or dirty abdominal surgery have more risk of surgical site infections. The investigators intend to randomize this kind of patients and comparison wound healing after dressed with incisional negative pressure wound therapy or standard dressing. In the study group INPWT (Prevena) is positioned immediately next surgery and dressed for six days. Every patients will be medicate in sixth, ninth, fifteenth and thirtieth day after surgery and will be valued wound healing with a scale score. Moreover for each patient it will be assessed risk developing wound complications through possum score and comorbidities.

Official Title
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Wound Healing After Dirty/Contaminated Emergency Abdominal Surgery: Prevena™ Incision Management System vs Conventional Management

Conditions
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Wound Healing, Prevena, Dirty Abdominal Surgery, Contaminated Abdominal Surgery, Emergency Abdominal Surgery, Negative-Pressure Wound Therapy

Intervention / Treatment
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* Device: incisional negative pressure wound therapy
* Device: conventional dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: abdominal surgery open surgery contaminated or dirty surgery Exclusion Criteria: not abdominal surgery mininvasive surgery clean surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevena arm<br>patients underwent to contaminated/dirty surgery who positioned incisional negative pressure wound therapy and kept for six days | Device: incisional negative pressure wound therapy<br>* positioning incisional negative pressure therapy over closed wound.<br>* Other names: Prevena - KCI;|
| Active Comparator: Control arm<br>patients underwent to contaminated/dirty surgery who positioned conventional dressing | Device: conventional dressing<br>* positioning conventional dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection (SSI) reduction | quantify SSI decrease after incisional negative pressure wound therapy | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection (SSI) and risk factors as diabetis, obesity and cancer | check connection between wound complications and risk factors and showing if Incisional Negative Pressure Wound Therapy (INPWT) could reduce effects of these risk factors | 2 years |