Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections

Study Overview
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Brief Summary
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Pancreaticoduodenectomy is associated with high perioperative morbidity, with surgical site infection (SSIs) being one of the most common complications. A retrospective study at Hopkins on SSIs in these patients identified the rate of SSIs to be 16.7% and pre-operative bile stent/drain and neoadjuvant chemotherapy were independent predictors of surgical site infection. Patients with these factors having a predicted risk of up to 32%. Another subsequent retrospective study demonstrated that the use of negative pressure wound therapy device was significantly associated with a decrease in the rate of SSIs. The hypothesis of the investigator(s) for the current study is that placement of Prevena Peel & Place Dressing (Negative Pressure Wound Therapy, NPWT) in patients undergoing pancreaticoduodenectomy who are at high risk of SSIs will result in a significant decrease in their SSI rate.

Detailed Description
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Although outcomes of pancreaticoduodenectomy have improved, it remains a procedure with a high perioperative complication rate. Surgical site infection is one of the most common complications after pancreaticoduodenectomy. In a retrospective review of all patients who underwent pancreaticoduodenectomy at Johns Hopkins between 9/2011 and 8/2014, a total of 679 patients, 30-day surgical site infection was observed in 16.7%. By univariate analysis, perioperative blood transfusion, operative time greater than 7 hours, preoperative chemotherapy and/or radiation, bile stent, absence of a superficial wound vacuum closure device, and vascular resection were associated with surgical site infection (all, p<0.05). On multivariable analysis, pre-operative bile stent/drain and neoadjuvant chemotherapy were independent predictors of surgical site infection (all, p<0.001). Studies in colorectal patients have found an estimated cost of up to $1400 per patient secondary to prolonged hospitalization, wound care, and wound complications in patients with procedures complicated by a surgical site infection. Furthermore, in another study of 1144 patients undergoing pancreaticoduodenectomy between 1995 and 2011 at Johns Hopkins Hospital, post-operative complications delayed time to adjuvant therapy, decreased median survival. The hypothesis of the investigator(s) is that placement of Prevena Peel & Place Dressing using the standard Acelity vacuum dressing after suture on patients undergoing pancreaticoduodenectomy at highest risk of infection will result in a significant decrease in surgical site infection rate. The investigator(s) plan to perform a randomized control trial where the patients who have had pre-operative bile stent/drain placement and/or neoadjuvant chemotherapy will undergo closure with Prevena Peel & Place Dressing using the standard Acelity vacuum dressing after suture versus standard closure. The investigator(s) will then follow the participant(s) for 30 days postoperatively to determine surgical site infection and other perioperative complication rate.

Official Title
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A Randomized Control Trial of Prevena Peel & Place Dressing Versus Standard Closure for Patients Undergoing Pancreaticoduodenectomy Who Have Undergone Neoadjuvant Chemotherapy or Biliary Stent Placement

Conditions
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Surgical Site Infection, Pancreatic Neoplasms, Pancreatic Cancer, Chemotherapy Effects, Chemoradiation, Surgical Wound, Wound Complication

Intervention / Treatment
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* Device: Prevena Peel & Place Dressing
* Other: Standard Closure of the Surgical Incision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient to undergo pancreaticoduodenectomy for pancreatic tumors at the Johns Hopkins Hospital Patient treated with neoadjuvant chemotherapy with or without radiation therapy prior to surgical resection, AND/OR placement of a biliary stent and/or drain for biliary tree decompression Exclusion Criteria: Age 18 years or younger Laparoscopic or robotic pancreaticoduodenectomy Patient did not undergo either placement of a preoperative biliary stent/drain or neoadjuvant chemotherapy with or without radiation therapy All patients who are have known allergies or are sensitive to silver and acrylic adhesives

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevena Peel & Place Dressing for wound closure<br>In the participants randomized to this arm the surgical site will be closed using Prevena Peel & Place Dressing. | Device: Prevena Peel & Place Dressing<br>* Prevena Peel & Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound<br>|
| Placebo Comparator: Standard closure of the wound<br>In the participants randomized to this arm the surgical site will be closed using the standard closure technique. | Other: Standard Closure of the Surgical Incision<br>* This would involve standard closure of the incision site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Surgical Site Infection | Surgical site infection will be diagnosed and classified based on the World Health Organization definition into superficial Infection (involving only skin and subcutaneous tissue of incision), deep incisional (involving deep tissues) or organ/space (involving organs and spaces other than the incision which was opened or manipulated during operation) | Within 30 days of the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged Length of Stay, Measured in Days | Length of stay of patient at the hospital from date of surgery | Within 10 days of surgery | 
| Rate of Readmission for Surgical Site Infections (SSIs) | Any readmission for surgical site infections (SSIs) related to the surgery within the first 30 days after surgery | Within 30 days of operation | 
| 30-d Readmission | Need for 30-day readmission | Within 30 days of surgery |