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Completed

NCT Number: NCT02581904

A Randomized Clinical Trial Evaluating Negative Pressure Therapy to Decrease Vascular Groin Incision Complications

The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.

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Key information

Conditions

Wound Infection Aneurysm Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Postoperative Complications Surgical Wound Dehiscence Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

The study randomizes patients (1:1) considered high risk, according to a specific set of risk factors, for wound complications into standard post-op dressings vs. Prevena vacuum dressing. The wounds will then be assessed for wound complications in the 30 days postoperatively. Wound complications include breakdown, infection and lymph leak. Patients not considered high risk will have standard post-op dressings and followed similarly to controls. The investigators will also assess economic impact of negative pressure dressing on length of stay and overall inpatient costs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing a femoral incision during vascular reconstruction or repair will be considered for study

Exclusion criteria

  • Emergency procedure
  • Unable to give informed consent

Treatment and study plan

Prevena Care

Device

The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.

Other names: Closed Incision Negative Pressure Device

Dry gauze dressing care

Device

Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily

Primary outcomes

  1. Groin Wound Complication

    Time frame: 30 days

    Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma

Secondary outcomes

  1. Hospital Length of Stay

    Time frame: 30 days

    Readmission to inpatient hospital for management of wound complications

  2. Return to Operating Room

    Time frame: 30 days

    Return to operating room for surgical management of wound complications

  3. Hospital Readmission

    Time frame: 30 days

    Readmission for wound complication

  4. Index Hospital Cost

    Time frame: 30 days

    Index Hospital Cost

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Evaluation of Closed Incision Negative Pressure Device (Prevena) to Prevent Vascular Wound Complications

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 21, 2015
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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