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

NCT02803164 | Completed Results FDA Device

• 1 other identifier: 16-002486
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Open Chest Wounds

Outcome Measures

Primary Outcomes (1)

• Duration of Negative Pressure Wound Therapy (NWPT)

  The total number of days of receiving NWPT

  12 month follow up

Secondary Outcomes (2)

• Wound Closure

  12 months

• Length of Hospital Stay

  12 months

Study Arms (2)

Vacuum-assisted dressing

OTHER

Eligible subjects will receive negative pressure wound therapy during surgery.

Device: Wound Vacuum-assisted dressing

Historical control group for comparison

OTHER

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

Other: Control group

Interventions

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).

Also known as: Wound Vacuum-assisted dressing (V-AD)

Vacuum-assisted dressing

Control group OTHER

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

Historical control group for comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mauricia Buchanan

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Dr. Mathew Thomas
• Organization: Mayo Clinic

thomas.mathew@mayo.edu

904-953-2000

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 16, 2016
• Study Start: February 10, 2017
• Primary Completion: November 3, 2020
• Study Completion: November 3, 2020
• Last Updated: September 29, 2021
• Results First Posted: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)