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OpenTrials
Completed

NCT Number: NCT02803164

Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds

Vacuum-assisted dressings (V-AD) are effective in treating patients with open chest wounds (OCW) and will decrease the time-to-closure of such wounds when compared to a historical cohort of patients managed by traditional wound care management.

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Key information

Conditions

Open Chest Wounds

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mauricia Buchanan

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is scheduled to undergo surgical intervention(s) as part of the standard care for management of intra-thoracic infection.

Exclusion criteria

  • Patent bronchopleural fistulas. Severe respiratory failure requiring mechanical ventilation at the time of first consultation.
  • Proven or suspected malignancy in the wound. Coagulopathy due to medical or pharmacologic reasons. Dependency on anticoagulants or antiplatelet medication due to high risk for adverse events if these medications are stopped for a prolonged period of time.

Allergy to acrylic products.

Treatment and study plan

Wound Vacuum-assisted dressing

Device

The NPWT system (V.A.C. Therapy System, KCI USA Inc.) consisted of a medical-grade non-adherent polyvinyl alcohol white foam applied directly to the infected surface, followed by an open-pore reticulated polyurethane black foam cut to fit the wound and covered by a transparent air-tight adhesive drape. A suction cup with tubing was placed over a small slit on the drape and connected to a suction machine (V.A.C. ULTA Therapy Unit).

Other names: Wound Vacuum-assisted dressing (V-AD)

Control Group

Other

Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.

Primary outcomes

  1. Duration of Negative Pressure Wound Therapy (NWPT)

    Time frame: 12 month follow up

    The total number of days of receiving NWPT

Secondary outcomes

  1. Wound Closure

    Time frame: 12 months

    The total number of days to wound closure

  2. Length of Hospital Stay

    Time frame: 12 months

    The total number of days in hospital

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Pilot Study to Evaluate the Efficacy of Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2016
Registry last updated
Sep 29, 2021

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.