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Not listed No phase listed Observational

Assess the Efficacy of Prevena Plus vs SOC to Closed Incision in Pts Undergoing CAWR and Other Laparotomy Procedures.

ClinicalTrials.gov ID: NCT04539015

Public ClinicalTrials.gov record NCT04539015. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 7:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized Study to Evaluate the Efficacy of Applying Prevena Plus to Closed Surgical Incision in Patients Undergoing CAWR and Other Laparotomy Procedures vs SOC Surgical Incision Dressing in Preventing SSI

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this study to establish the efficacy of Prevena™ Plus in preventing surgical site infection after complex abdominal wall procedures and major laparotomies as compared to SOC dressing. We hypothesized that use of Prevena Plus will significantly decrease the incidence of Surgical Site Infection (SSI) and subsequently may have an impact over reducing hospital cost. Study data will be analyzed for clinical outcomes through 30 days. The patients will be followed every day during the hospital stay and study follow-up visits will be conducted in the clinic at 2 weeks and 1 month from the date of discharge.

Study identification

NCT ID
NCT04539015
Recruitment status
Not listed
Study type
Observational
Phase
Not listed
Lead sponsor
New York Medical College
Other
Enrollment
170 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 8, 2020
Primary completion
Dec 29, 2022
Completion
Feb 27, 2023
Last update posted
Sep 3, 2020

2020 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Westchester Medical Center Valhalla New York 10595 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04539015, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2020 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04539015 live on ClinicalTrials.gov.

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