Prevena Incision Management System Wound Care

Terminated

• Conditions: Ventral Hernia

• Registration Number: NCT02953769
• Lead Sponsor: AdventHealth

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.

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-03
• Study Start: 2017-03-29
• Primary Completion: 2018-10-16
• Study Completion: 2018-10-16
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Florida Hospital Celebration Health; 🇺🇸 Celebration, Florida, United States