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Negative Pressure Wound Therapy vs Standard Care Dressing

NCT ID: NCT03566641

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-28

Study Completion Date

2019-04-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Negative-Pressure Wound Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparing the rate of occurrence of surgical site infection, total hospital cost and length of stay between two groups: group 1 represents patients who receive Prevena for postoperative wound care and group 2 represents patients who receive standard care dressing for the same purpose.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Out study is a single-blinded randomized clinical trial. The patient will be informed about the type of dressing used for their wound care, but the investigator and the outcome assessor will be blinded for which type of dressing used for each participant patient.

Study Groups

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Negative pressure wound therapy

This group of patients will receive negative pressure wound therapy (prevena) as their postoperative wound care method.

Group Type EXPERIMENTAL

Negative pressure wound therapy

Intervention Type DEVICE

The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound.

standard care dressing

This group of patients will receive standard care dressing as their postoperative wound care method.

Group Type ACTIVE_COMPARATOR

standard care dressing

Intervention Type OTHER

The application of a standard care dressing (instead of negative pressure wound therapy) across the surface of wound.

Interventions

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Negative pressure wound therapy

The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound.

Intervention Type DEVICE

standard care dressing

The application of a standard care dressing (instead of negative pressure wound therapy) across the surface of wound.

Intervention Type OTHER

Other Intervention Names

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Prevena dray gauze

Eligibility Criteria

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Inclusion Criteria

* Consent for participation from the patient or his legal representative

Exclusion Criteria

* Currently infected wounds
* Patients with history of immunosupression
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toledo Health Science Campus

OTHER

Sponsor Role lead

Responsible Party

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Munier Nazzal, M.S. M.D

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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munier nazzal, md

Role: PRINCIPAL_INVESTIGATOR

UTMC

Locations

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UTMC

Toledo, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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Prevena V. 11/14/17

Identifier Type: -

Identifier Source: org_study_id

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