Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications

Study Overview
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Brief Summary
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The purpose of this study is to determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site infections (SSI) when compared to the standard of care dressing.

Detailed Description
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In an attempt to decrease wound infection incidence and improve healing time of open surgical wounds, vacuum assisted closure (VAC) was developed. This innovative technique provided contained controlled wound irrigation without bacterial aerosolization. A newer customizable subset of the Prevena incision Management System TM called Prevena Peel and Place TM has been released a few months ago. The new model can be cut to specific wound sizes and has a connector that can be attached to the already widely available VAC machines. The versatility and the comparability to older models of Prevena Peel and Place TM have not been tested to this date. The investigators believe that a randomized clinical trial evaluating the use of the Prevena Incision Management System TM for homecare and the use of Prevena Peel and Place TM for inpatients in special populations is warranted. Obese patients (BMI≥30) undergoing open surgery will have decreased surgical site infection rates, improved healing time, better quality of life (QOL) and lower readmission rates with use of Prevena in the post-operative management of surgical incisions.

Official Title
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The SAVIOR Trial: Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications

Conditions
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Wound Infection, Surgical, Obesity, Postoperative Complications

Intervention / Treatment
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* Device: Prevena
* Device: Standard Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) / Medical Ethics Committee (MEC) of the respective clinical site. Patient meets the criteria for and is undergoing open surgery at Johns Hopkins Medical Institutes. Patient with BMI≥ 30 at the time of surgery Patient agrees to return for all required clinical follow up for the study. Exclusion Criteria: Known allergic reaction to acrylic adhesives or silver. Known history of intolerance to any component of Prevena Incision Management System TM. Very fragile skin around incision site. Bleeding disorder or refuses blood transfusion. Malignancy or other condition limiting life expectancy to <5 years. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevena<br>After surgery this group will receive the Prevena device (negative pressure wound therapy). | Device: Prevena<br>* Prevena Incision Management system<br>|
| Active Comparator: Standard dressing<br>After surgery this group will receive standard of care dressings on their surgical wound. | Device: Standard Dressing<br>* This involves standard of care dressing including but not limited to gauze.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines | The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery | Up to 7 days postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other Wound Complications (Aggregate) | Dehiscence, seroma and hematoma. Reported as number of aggregate events. | Up to 14 days postop | 
| Skin Bacterial Count as Assessed by Microbacterial Count | Skin bacterial count after removal of either Prevena or standard dressing. A micro-bacterial swap will be performed and sent to the microbiology lab for assessing bacterial count | Up to 7 days postop | 
| Physical Function as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | 
| Readmissions | Readmission events for the patients. | Up to 30 days postop | 
| Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | 
| Social Functioning as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | 
| Energy / Fatigue as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Energy and fatigue are aggregated in this section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | 
| Emotional Well Being as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | 
| Pain as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | 
| General Health as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Obese, surgical site infection, closed incisions, negative pressure therapy