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NCT01704924 Clinical Trial

Prospective Observation of Wound Healing With Prevena Incision Management System

Scarring Clinical Trial

Official title:
Prospective Observation of Wound Healing With Prevena Incision Management System

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01704924
Other study ID # KCI-2011-8268
Secondary ID
Status Withdrawn
Phase N/A
First received October 9, 2012
Last updated January 17, 2018
Start date October 2012
Est. completion date December 2016

Study information
Verified date January 2018
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Prevena
Device will be applied at end of procedure over closed incision
Procedure:
• Standard of Care Dressing
Dressing applied as Standard of Care

Locations
Country Name City State
United States University of California at Irvine Orange California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (2)

Pachowsky M, Gusinde J, Klein A, Lehrl S, Schulz-Drost S, Schlechtweg P, Pauser J, Gelse K, Brem MH. Negative pressure wound therapy to prevent seromas and treat surgical incisions after total hip arthroplasty. Int Orthop. 2012 Apr;36(4):719-22. doi: 10.1007/s00264-011-1321-8. Epub 2011 Jul 15. — View Citation

Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Scarring Assess quality of scar: hypertrophy, hyperpigmentation, etc 0-6 months
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