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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.2 years study duration

Study Start

First participant enrolled

October 1, 2012

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed

4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed

Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

4.2 years

First QC Date

October 9, 2012

Last Update Submit

January 17, 2018

Conditions

Scarring

Keywords

Prevenanegative pressure wound therapyIncisional wound vac

Outcome Measures

Primary Outcomes (1)

Scarring
Assess quality of scar: hypertrophy, hyperpigmentation, etc
0-6 months

Study Arms (2)

Prevena

ACTIVE COMPARATOR

Incision with prevena device overlying

Device: Prevena

Standard of Care dressing

ACTIVE COMPARATOR

Prevena device is not used

Procedure: Standard of Care Dressing

Interventions

PrevenaDEVICE

Device will be applied at end of procedure over closed incision

Prevena

Standard of Care DressingPROCEDURE

Dressing applied as Standard of Care

Standard of Care dressing

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

abdominal procedure with incision \>20cm
must be \>18 years of age

You may not qualify if:

\<18 years of age
history of allergy or reaction to adhesives
pregnant or anticipated pregnancy within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of California, Irvinelead

Study Sites (1)

University of California at Irvine

Orange, California, 92868, United States

Location

Related 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.
PMID: 21761149BACKGROUND
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.
PMID: 21804414BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Gregory Evans, MD
The University of California Irvine
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 12, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations

US(1)

Study Stopped

Prospective Observation of Wound Healing With Prevena Incision Management System

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Prevena

Standard of Care dressing

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Prevena

Standard of Care dressing

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations