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NCT02953769 Clinical Trial

Prevena Incision Management System Wound Care

Ventral Hernia Clinical Trial

Official title:
Use of Prevena Incision Management System in Wound Morbidity in Complex Ventral Hernia Patients. A Prospective Randomized Control Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02953769
Other study ID # 951279
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 29, 2017
Est. completion date October 16, 2018

Study information
Verified date July 2019
Source Florida Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparison of ventral hernia repair using standard wound care versus Prevena.

Description:

Compare the outcomes for patients who have abdominal reconstruction for ventral hernia repair, regarding wound morbidity, post-operative pain and patient comfort to ambulation, with the use of Prevena™ to those patients who have ventral hernia repair to those who have standard wound care.

Recruitment information / eligibility
Status Terminated
Enrollment 61
Est. completion date October 16, 2018
Est. primary completion date October 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria:

1. Age 18 - 89

2. Open ventral hernia repair with or abdominal wall reconstruction after midline or non-midline defects.

3. Able to provide informed consent

Exclusion Criteria:

1. Immunosuppresses patients

2. Children 0 - 17

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Florida Hospital Celebration Health Celebration Florida

Sponsors (2)
Lead Sponsor Collaborator
Florida Hospital KCI USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Objective for Wound Care Comparison To quantify differences in the routine care of wound morbidity versus the use of Prevena™ by observing the healing process and obtaining quality of life by using the Carolinas Comfort Scale. December 31, 2017
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