Scarring
Conditions
Keywords
Prevena, negative pressure wound therapy, Incisional wound vac
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.
Interventions
DEVICEPrevena
Device will be applied at end of procedure over closed incision
PROCEDUREStandard of Care Dressing
Dressing applied as Standard of Care
Sponsors
University of California, Irvine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scarring | 0-6 months | Assess quality of scar: hypertrophy, hyperpigmentation, etc |
Countries
United States
Outcome results
None listed