Prevena Incision Management System Wound Care

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02953769

Enrollment

Registered

2016-11-03

Start date

2017-03-29

Completion date

2018-10-16

Last updated

2019-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventral Hernia

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Objective for Wound Care Comparison	December 31, 2017	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.

Countries

United States

Outcome results