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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-10

Study Completion Date

2020-11-03

Brief Summary

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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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Detailed Description

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Conditions

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Open Chest Wounds

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vacuum-assisted dressing

Eligible subjects will receive negative pressure wound therapy during surgery.

Group Type OTHER

Wound Vacuum-assisted dressing

Intervention Type 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).

Historical control group for comparison

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

Group Type OTHER

Control group

Intervention Type OTHER

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

Interventions

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Wound Vacuum-assisted dressing

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).

Intervention Type DEVICE

Control group

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

Intervention Type OTHER

Other Intervention Names

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Wound Vacuum-assisted dressing (V-AD)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No