Prospective Observation of Wound Healing With Prevena Incision Management System
- Conditions
- Scarring
- Interventions
- Procedure: Standard of Care DressingDevice: Prevena
- Registration Number
- NCT01704924
- Lead Sponsor
- University of California, Irvine
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- abdominal procedure with incision >20cm
- must be >18 years of age
- <18 years of age
- history of allergy or reaction to adhesives
- pregnant or anticipated pregnancy within 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care dressing Standard of Care Dressing Prevena device is not used Prevena Prevena Incision with prevena device overlying
- Primary Outcome Measures
Name Time Method Scarring 0-6 months Assess quality of scar: hypertrophy, hyperpigmentation, etc
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of California at Irvine
🇺🇸Orange, California, United States