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

Not Applicable

Terminated

Conditions: Wound Infection, Surgical
Obesity
Postoperative Complications

Interventions: Device: Standard Dressing
Device: Prevena

Registration Number: NCT02461433

Lead Sponsor: Johns Hopkins University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 2

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dressing	Standard Dressing	After surgery this group will receive standard of care dressings on their surgical wound.
Prevena	Prevena	After surgery this group will receive the Prevena device (negative pressure wound therapy).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Energy / Fatigue as Assessed by Short Form Survey (SF) 36	Up to 14 days postop	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
Social Functioning as Assessed by Short Form Survey (SF) 36	Up to 14 days postop	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
Emotional Well Being as Assessed by Short Form Survey (SF) 36	Up to 14 days postop	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
Other Wound Complications (Aggregate)	Up to 14 days postop	Dehiscence, seroma and hematoma. Reported as number of aggregate events.
Physical Function as Assessed by Short Form Survey (SF) 36	Up to 14 days postop	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
Skin Bacterial Count as Assessed by Microbacterial Count	Up to 7 days postop	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
Readmissions	Up to 30 days postop	Readmission events for the patients.
Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36	Up to 14 days postop	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
Pain as Assessed by Short Form Survey (SF) 36	Up to 14 days postop	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
General Health as Assessed by Short Form Survey (SF) 36	Up to 14 days postop	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