Study to Analyze the Surgical Site Infections in a Group of Patients Who Were Randomly Applied a Negative Pressure Therapy Dressing Versus Conventional Dressing

Study Overview
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Brief Summary
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Surgical site complications generate a series of consequences that prolong hospital stay, increase interventions and procedures, and consequently considerably increase healthcare costs. Hence, the importance of studying measures to reduce these complications and the most feared of them is surgical site infection. The objective of the study is to analyze the complications of the surgical site in a group of participante with risk factors for developing them after undergone abdominal surgery in the period described.

Detailed Description
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All non-consecutive participants operated on in a hospital were included, both those who, based on a protocol prepared by the investigators unit, were classified as having no risk of developing complications, low risk or high risk. Partfipants classified as low and high risk, after their consent to participate in the study, entered to form part of it. This participanta were classified before surgery according to the risk factors of themselves and of the procedure, and those at risk were randomized to treatment with a negative pressure therapy dressing or no treatment, and a cure was performed with a conventional dressing. The participants classified as not at risk of complications were not included in the study. In this way the investigators tried to analyze if the intervention with the negative pressure therapy dressing reduced the complications of the surgical site.The primary objective was to analyze the reduction of surgical site infections in participants treated with negative pressure therapy compared to those treated with conventional dressing. As secondary objectives the investigators proposed to measure other complications in both groups and the hospital stay.

Official Title
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Randomized Study on the Efficacy of Negative Pressure Wound Therapy (NPWT) in the Prevention of Surgical Site Complications

Conditions
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Surgical Site Infection, Complication,Postoperative, Surgical Wound Infection, Surgical Complication

Intervention / Treatment
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* Device: negative preassure wound therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with risk factors for developing surgical site complications undergo abdominal surgery consent of the patient to participate in the study Exclusion Criteria: non-consent of the patient to participate in the study patients without risk of developing surgical site complications

Ages Eligible for Study
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Minimum Age: 14 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomly apply a negative pressure therapy dressing in the operating room to heal a surgical wound or a conventional dressing without negative pressure in those patients at high risk of presenting complications and surgical site infections
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: negative wound therapy group<br>those who receive negative pressure therapy | Device: negative preassure wound therapy<br>* wound treated with negative pressure therapy dressing<br>|
| No Intervention: conventional dressing group<br>those patients who heal with conventional dressing, therefore negative pressure therapy is not applied | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical site complications | development of surgical site infection of wound seroma, skin dehiscence, wound necrosis | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay | days | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical site infections, prophylaxis, negative pressure wound therapy, abdominal surgery