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WithdrawnNCT01704924Updated Jan 19, 2018

Prospective Observation of Wound Healing With Prevena Incision Management System

An interventional study of Prevena and Standard of Care Dressing in Scarring, sponsored by University of California, Irvine. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-19.

Sponsored by University of California, Irvine · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
No study subjects enrolled, Investigator decided to cancel the project
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Scarring

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Keywords

  • Prevena
  • negative pressure wound therapy
  • Incisional wound vac
03

In context

Cicatrix

307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.

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Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Prevena

    Incision with prevena device overlying

    Device: Prevena

  • Active comparator
    Standard of Care dressing

    Prevena device is not used

    Procedure: Standard of Care Dressing

Interventions

  • DevicePrevena

    Device will be applied at end of procedure over closed incision

  • ProcedureStandard of Care Dressing

    Dressing applied as Standard of Care

06

What researchers measure

Primary outcomes

  1. Scarring

    Assess quality of scar: hypertrophy, hyperpigmentation, etc

    Time frame: 0-6 months

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Study locations

1 site
  • University of California at Irvine
    Orange, California 92868, United States
08

References and documents

Publications

  • 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. PubMed 21761149 ↗
  • 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. PubMed 21804414 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01704924
Lead sponsor
University of California, Irvine
Responsible party
Gregory R. Evans (Professor, University of California, Irvine) — Principal investigator
First posted
Oct 12, 2012
Start date
Oct 2012
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jan 19, 2018

Study contacts

Gregory Evans, MD
principal investigator · The University of California Irvine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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