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

NCT03021668 | Completed Results

• 1 other identifier: IRB00109564
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Prolonged Length of Stay, Measured in Days

  Within 10 days of surgery

• Rate of Readmission for Surgical Site Infections (SSIs)

  Within 30 days of operation

• 30-d Readmission

  Within 30 days of surgery

Study Arms (2)

Prevena Peel & Place Dressing for wound closure

EXPERIMENTAL

In the participants randomized to this arm the surgical site will be closed using Prevena Peel \& Place Dressing.

Device: Prevena Peel & Place Dressing

Standard closure of the wound

PLACEBO COMPARATOR

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

Interventions

Prevena Peel & Place Dressing 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

Prevena Peel & Place Dressing for wound closure

Standard Closure of the Surgical Incision OTHER

This would involve standard closure of the incision site

Standard closure of the wound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 212187, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection; Pancreatic Neoplasms; Surgical Wound

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Wounds and Injuries

Limitations and Caveats

The study was conducted at a high volume center for pancreatic surgery with a broad experience using Negative-Pressure Wound Therapy (NPWT), and therefore there is a question about the generalizability of the reductions we observed.

Results Point of Contact

• Title: Dr. Matthew J. Weiss
• Organization: Johns Hopkins Hospital

mweiss5@jhmi.edu

4106143368

Study Officials

• Matthew J Weiss, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 16, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: June 30, 2018
• Last Updated: August 28, 2019
• Results First Posted: February 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)