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

Open Chest Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803164
• Other study ID #: 16-002486
• Status: Completed
• Phase: N/A
• Start date: February 10, 2017
• Est. completion date: November 3, 2020

Study information

• Verified date: September 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 3, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Open Chest Wounds
• Wounds and Injuries

Intervention

Device:
• 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).

Other:
• Control group
Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.

Locations

Country	Name	City	State
United States	Mauricia Buchanan	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Negative Pressure Wound Therapy (NWPT)	The total number of days of receiving NWPT	12 month follow up
Secondary	Wound Closure	The total number of days to wound closure	12 months
Secondary	Length of Hospital Stay	The total number of days in hospital	12 months

External Links

•   Mayo Clinic Clinical Trials
•   Published manuscript