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Negative Pressure Wound Therapy vs Standard Care Dressing

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03566641
Acronym
Prevena
Enrollment
0
Registered
2018-06-25
Start date
2018-04-28
Completion date
2019-04-15
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Negative-Pressure Wound Therapy

Brief summary

A comparison between the efficacy of negative pressure wound therapy and the efficacy of 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.

Interventions

DEVICENegative pressure wound therapy

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

OTHERstandard care dressing

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

Sponsors

University of Toledo Health Science Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Consent for participation from the patient or his legal representative

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Surgical site infection30-day postoperative periodThe rate of occurrence of signs and symptoms of surgical site infection

Secondary

MeasureTime frameDescription
length of total hospital stay6 monthsnumber of days of patients hospital stay after the surgery
cost of hospitalization6 monthsThe total cost in USD of patient's hospitalization
Rate of reoperation30-day postoperative periodThe rate of patients' re-operation after the principal operation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026