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

NCT04539015 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2020-09-04

No results posted yet for this study

Summary

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.

Conditions

  • Hernia

Interventions

DEVICE

Prevena Plus

PREVENA Plus is a negative pressure wound therapy device intended for use on surgical incisions that continue to drain following sutured or stapled closures.

Sponsors & Collaborators

  • Acelity

    collaborator OTHER

  • New York Medical College

    lead OTHER

Principal Investigators

  • Rifat Latifi, MD · Chairman Department of Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2022-12-30
Completion
2023-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04539015 on ClinicalTrials.gov