Negative Pressure Wound Therapy vs Standard Care Dressing (Prevena)

A Comparison of Negative Pressure Wound Therapy vs Standard Care, for Vascular, Plastic and General Surgery

A comparison between the efficacy of negative pressure wound therapy and the efficacy of standard care dressing

Study Overview

• Status: Withdrawn
• Conditions: Negative-Pressure Wound Therapy
• Intervention / Treatment: Device: Negative pressure wound therapy; Other: standard care dressing

Detailed Description

The aim of our study is to compare the efficacy of negative pressure wound therapy (Prevena) and standard clinical dressing in terms of prevention of postoperative surgical site infection, length of hospital stay, and total cost of hospitalization among vascular, plastic and general surgery patients.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43614
      • UTMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Consent for participation from the patient or his legal representative

Exclusion Criteria:

• Currently infected wounds
• Patients with history of immunosupression
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Negative pressure wound therapy; This group of patients will receive negative pressure wound therapy (prevena) as their postoperative wound care method.	Device: Negative pressure wound therapy; The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound.; Other Names: Prevena
Active Comparator: standard care dressing; This group of patients will receive standard care dressing as their postoperative wound care method.	Other: standard care dressing; The application of a standard care dressing (instead of negative pressure wound therapy) across the surface of wound.; Other Names: dray gauze

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection	The rate of occurrence of signs and symptoms of surgical site infection	30-day postoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of total hospital stay	number of days of patients hospital stay after the surgery	6 months
cost of hospitalization	The total cost in USD of patient's hospitalization	6 months
Rate of reoperation	The rate of patients' re-operation after the principal operation	30-day postoperative period

Collaborators and Investigators

• Sponsor: University of Toledo Health Science Campus
• Investigators: Principal Investigator: munier nazzal, md, UTMC

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 18, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Prevena V. 11/14/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes