Prospective Observation of Wound Healing With Prevena Incision Management System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Scarring
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •abdominal procedure with incision >20cm
- •must be >18 years of age
Exclusion Criteria
- •<18 years of age
- •history of allergy or reaction to adhesives
- •pregnant or anticipated pregnancy within 6 months
Outcomes
Primary Outcomes
Scarring
Time Frame: 0-6 months
Assess quality of scar: hypertrophy, hyperpigmentation, etc
Secondary Outcomes
No secondary outcomes reported
Investigators
Gregory R. Evans
Professor
University of California, Irvine