Negative Pressure Wound Therapy vs Standard Care Dressing

NCT03566641 | Withdrawn FDA Device

• 1 other identifier: Prevena V. 11/14/17
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Negative-Pressure Wound Therapy

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  The rate of occurrence of signs and symptoms of surgical site infection

  30-day postoperative period

Secondary Outcomes (3)

• length of total hospital stay

  6 months

• cost of hospitalization

  6 months

• Rate of reoperation

  30-day postoperative period

Study Arms (2)

Negative pressure wound therapy

EXPERIMENTAL

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

Device: Negative pressure wound therapy

standard care dressing

ACTIVE COMPARATOR

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

Other: standard care dressing

Interventions

Negative pressure wound therapy DEVICE

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

Also known as: Prevena

Negative pressure wound therapy

standard care dressing OTHER

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

Also known as: dray gauze

standard care dressing

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent for participation from the patient or his legal representative

You may not qualify if:

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

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead

Study Sites (1)

UTMC

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• munier nazzal, md

  UTMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: June 25, 2018
• Study Start: April 28, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 15, 2019
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)