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

NCT ID: NCT03021668

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-06-30

Brief Summary

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

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.

Conditions

Surgical Site Infection; Pancreatic Neoplasms; Pancreatic Cancer; Chemotherapy Effects; Chemoradiation; Surgical Wound; Wound Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prevena Peel & Place Dressing

Intervention Type: DEVICE

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

Standard closure of the wound

In the participants randomized to this arm the surgical site will be closed using the standard closure technique.

Group Type: PLACEBO_COMPARATOR

Standard Closure of the Surgical Incision

Intervention Type: OTHER

This would involve standard closure of the incision site

Interventions

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

Intervention Type: DEVICE

Standard Closure of the Surgical Incision

This would involve standard closure of the incision site

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew J Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00109564

Identifier Type: -

Identifier Source: org_study_id