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

NCT03021668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2019-08-28

Study results available
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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

Interventions

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

OTHER

Standard Closure of the Surgical Incision

This would involve standard closure of the incision site

Sponsors & Collaborators

Principal Investigators

  • Matthew J Weiss, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-05-31
Completion
2018-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03021668 on ClinicalTrials.gov