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Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications

NCT02461433 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-02-26

Study results available
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Summary

The purpose of this study is to determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site infections (SSI) when compared to the standard of care dressing.

Conditions

  • Wound Infection, Surgical
  • Obesity
  • Postoperative Complications

Interventions

DEVICE

Prevena

Prevena Incision Management system

DEVICE

Standard Dressing

This involves standard of care dressing including but not limited to gauze.

Sponsors & Collaborators

Principal Investigators

  • Kimberley Steele, MD, PHD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-03-31
Completion
2017-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02461433 on ClinicalTrials.gov