Prospective Observation of Wound Healing With Prevena Incision Management System

NCT ID: NCT01704924

Last Updated: 2018-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Scarring

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Prevena

Incision with prevena device overlying

Group Type ACTIVE_COMPARATOR

Prevena

Intervention Type DEVICE

Device will be applied at end of procedure over closed incision

Standard of Care dressing

Prevena device is not used

Group Type ACTIVE_COMPARATOR

Standard of Care Dressing

Intervention Type PROCEDURE

Dressing applied as Standard of Care

Interventions

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Prevena

Device will be applied at end of procedure over closed incision

Intervention Type DEVICE

Standard of Care Dressing

Dressing applied as Standard of Care

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Gregory R. Evans

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory Evans, MD

Role: PRINCIPAL_INVESTIGATOR

The University of California Irvine

Locations

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University of California at Irvine

Orange, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21761149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21804414 (View on PubMed)

Related Links

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http://www.kci1.com/KCI1/prevena

Prevena Product Website

Other Identifiers

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KCI-2011-8268

Identifier Type: -

Identifier Source: org_study_id

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