Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03566641
Other study ID # Prevena V. 11/14/17
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT02892435 - Prevena™ Incision Management System vs Conventional Management for Wound Healing Phase 2
Recruiting NCT04618406 - The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower Limb N/A
Not yet recruiting NCT01603901 - Regulated Negative Pressure-Assisted Wound Therapy Device N/A
Terminated NCT04026334 - Evaluation of V.A.C. VERAFLO CLEANSE CHOICE™ Dressing Using Normal Saline to Promote Increased Healthy Wound Bed Tissue N/A
Completed NCT02682316 - Negative Pressure Wound Therapy in Post-Operative Incision Management Phase 3
Recruiting NCT05716503 - Comparison Between Negative Pressure Wound Therapy and Conventional Wound Dressings Before and After Split-Thickness Skin Grafting in Diabetic Foot Wounds N/A
Recruiting NCT02901613 - Prophylactic Post-Cesarean Incisional Negative-pressure Wound Therapy in Morbidly Obese Patients N/A
Completed NCT02526342 - Impact of Negative Pressure Wound Therapy on Free Muscle Flaps N/A