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

August 13, 2019 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 212187
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prevena Peel & Place Dressing for wound closure
In the participants randomized to this arm the surgical site will be closed using Prevena Peel & Place Dressing.
Device: Prevena Peel & Place Dressing
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
Placebo Comparator: Standard closure of the wound
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
This would involve standard closure of the incision site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Surgical Site Infection
Time Frame: Within 30 days of the operation
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
Time Frame: Within 10 days of surgery
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)
Time Frame: Within 30 days of operation
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
Time Frame: Within 30 days of surgery
Need for 30-day readmission
Within 30 days of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Matthew J Weiss, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

January 6, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00109564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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