NCT01704924

Prospective Observation of Wound Healing With Prevena Incision Management System

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to assess the quality of wound healing in abdominal scars with and without the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved wound healing with less swelling, bruising, and inflammation, as well as less potential for infection, seroma, and dehiscence.

Detailed description

The quality of wound healing can be of the utmost importance for patients undergoing large abdominal surgery. Incisional negative pressure wound therapy has been observed to decrease seroma and infection rates in high risk patients. This study aims to quantify the effect, if any, that negative pressure wound therapy has on closed incisions. The technology may provide benefits even in lower risk patients.

Conditions

• Scarring

Interventions

Type	Name	Description
DEVICE	Prevena	Device will be applied at end of procedure over closed incision
PROCEDURE	Standard of Care Dressing	Dressing applied as Standard of Care

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2012-10-12
• Last updated: 2018-01-19

Locations

1 site across 1 country: United States