Negative Pressure Wound Therapy vs Standard Care Dressing

Negative-Pressure Wound Therapy Clinical Trial

— Prevena  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03566641
• Other study ID #: Prevena V. 11/14/17
• Status: Withdrawn
• Phase: N/A
• Start date: April 28, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: May 2024
• Source: University of Toledo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 15, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Consent for participation from the patient or his legal representative

Exclusion Criteria:

• Currently infected wounds

• Patients with history of immunosupression

• Pregnancy

Related Conditions & MeSH terms

• Negative-Pressure Wound Therapy
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	UTMC	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	The rate of occurrence of signs and symptoms of surgical site infection	30-day postoperative period
Secondary	length of total hospital stay	number of days of patients hospital stay after the surgery	6 months
Secondary	cost of hospitalization	The total cost in USD of patient's hospitalization	6 months
Secondary	Rate of reoperation	The rate of patients' re-operation after the principal operation	30-day postoperative period