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The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing

NCT02302222 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-10-16

Study results available
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Summary

The goal of this study is to evaluate the impact of Customizable in the management of extensive closed surgical incisions for Subjects undergoing abdominal surgery for incisional hernia repair and/or functional panniculectomy as compared to SOC dressing, and to significantly reduce the SSC rate experienced by Subjects receiving Customizable vs. SOC surgical incision dressing.

Conditions

  • Herniorrhaphy
  • Abdominoplasty

Interventions

DEVICE

Customizable Dressing with ActiV.A.C. Therapy Unit

DEVICE

Standard of Care Dressing

Sponsors & Collaborators

  • KCI USA, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-07-31
Completion
2017-07-31

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 NCT02302222 on ClinicalTrials.gov