Prospective Observation of Wound Healing With Prevena Incision Management System

University of California Irvine (UCI)

Status: Withdrawn

Conditions: Scarring

Treatments: Procedure: Standard of Care Dressing; Device: Prevena

Study type: Interventional

Funder types: Other

Identifiers

NCT01704924

KCI-2011-8268

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Prevena

Active Comparator group

Description:

Incision with prevena device overlying

Treatment:

Device: Prevena

Standard of Care dressing

Active Comparator group

Description:

Prevena device is not used

Treatment:

Procedure: Standard of Care Dressing